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3. MA11.07 Phase 1/2 TRIDENT-1 Study of Repotrectinib in Patients with ROS1+ or NTRK+ Advanced Solid Tumors

Author

S. Kao, A. J. van der Wekken, Christina S. Baik, Matthew G Krebs, A. Drilon, R. Camidge, Byoung Chul Cho, Vamsidhar Velcheti, Ben Solomon, Jessica Lin, Shanna Stopatschinskaja, Viola W. Zhu, Stephen V. Liu, Robert C. Doebele, K.H. Lee, and Misako Nagasaka

Subjects
Pulmonary and Respiratory Medicine, Oncology, business.industry, Phase (matter), ROS1, Medicine, In patient, Trident, business, Nuclear medicine
Published
2021

4. P76.14 Time to First Progression in Patients with NSCLC with Brain Metastases Receiving 3rd Generation TKI alone vs TKI + Brain Radiation

Author

Chad G. Rusthoven, Tejas Patil, R. Camidge, Heather A. Wakelee, Seema Nagpal, Caroline E. McCoach, C. Yu, Rao Mushtaq, Fangdi Sun, Steve Braunstein, Nicholas J. Thomas, Erqi L. Pollom, and Nathaniel J. Myall

Subjects
Pulmonary and Respiratory Medicine, Oncology, medicine.medical_specialty, Brain radiation, business.industry, Internal medicine, medicine, In patient, business
Published
2021

5. P09.53 Comparative Effectiveness of Crizotinib versus Entrectinib in ROS1+ Non-Small Cell Lung Cancer (NSCLC) using Clinical Trial and Real-World Data

Author

Gabriel Tremblay, R. Wiltshire, L. Bartolome, Keith D. Wilner, M. Groff, L. Iadeluca, R. Camidge, Joseph C. Cappelleri, and Tiziana Usari

Subjects
Pulmonary and Respiratory Medicine, Oncology, medicine.medical_specialty, Crizotinib, business.industry, non-small cell lung cancer (NSCLC), Entrectinib, medicine.disease, Clinical trial, Internal medicine, medicine, ROS1, business, Real world data, medicine.drug
Published
2021

6. FP14.06 Multicenter Analysis of Mechanisms of Resistance to Osimertinib (O) in EGFR Mutated NSCLC: An ATOMIC Registry Study

Author

Joshua Bauml, C. Succe, Benjamin Levy, R. Murkherji, J. Woodley, Wade T. Iams, Kristen A. Marrone, Leora Horn, Caroline E. McCoach, W. Schwartzman, Stephen V. Liu, R. Camidge, Jonathan E. Dowell, Jared Weiss, Fangdi Sun, X. Wang, M. Shah, Vamsidhar Velcheti, Rosemarie Mick, T. Ullah, Jorge Nieva, R. Moreno, Liza C. Villaruz, K. Shaverdashvili, Neil Miller, Dara L. Aisner, G. Liu, Tejas Patil, Natasha B. Leighl, Christine M. Lovly, and Robert C. Doebele

Subjects
Pulmonary and Respiratory Medicine, Oncology, medicine.medical_specialty, business.industry, Internal medicine, Registry study, medicine, Osimertinib, business
Published
2021

7. Brigatinib vs crizotinib in patients with ALK inhibitor-naive advanced ALK+ NSCLC: Updated results from the phase III ALTA-1L trial

Author

M.R. Garcia Campelo, K.H. Lee, M. Tiseo, Angelo Delmonte, Myung-Ju Ahn, Enriqueta Felip, Maximilian Hochmair, Frank Griesinger, R. Camidge, Sanjay Popat, J-Y. Han, Dai Woo Kim, Pingkuan Zhang, Scott N. Gettinger, J.C.-H. Yang, Raffaele Califano, Q. Ni, Alexander I. Spira, and H.R. Kim

Subjects
ALK inhibitor, Oncology, Brigatinib, Crizotinib, business.industry, medicine.drug_class, Cancer research, Medicine, In patient, Hematology, business, medicine.drug
Published
2019

8. P84.03 GLASS: Global Lorlatinib for ALK(+) and ROS1(+) Retrospective Study: Real World Data of 123 NSCLC Patients

Author

Ömer Fatih Ölmez, Sadettin Kilickap, F. Çay Şenler, R. Camidge, Aziz Karaoglu, Ilhan Oztop, Muhammet Ali Kaplan, Cengiz Yilmaz, Mustafa Erman, R. Grinberg, Sergey Orlov, Irfan Cicin, Petros Christopoulos, Roni Gillis, Ahmet Demirkazik, Perran Fulden Yumuk, Deniz Tural, Ozgur Ozyilkan, N. Peled, Elizabeth Dudnik, Adnan Aydiner, Saime Paydas, Dogan Yazilitas, Yesim Eralp, Nezih Meydan, Havva Yesil Cinkir, Kerem Okutur, Kubra Aydin, H. Şenol Coşkun, Ismail Beypinar, F. Bugdayci Basal, Julien Mazieres, Noemi Reguart, Oliver Gautschi, Devrim Cabuk, M. Fedor, L. Roisman, M.A. Nahit Şendur, Taner Korkmaz, Abdurrahman Isikdogan, Alisan Zirtiloglu, Hande Turna, Patrizia Froesch, Terry L. Ng, Ahmet Sezer, E. Filippova, Umut Demirci, and Ibrahim Yildiz

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, Oncology, business.industry, ROS1, Medicine, Retrospective cohort study, Medical physics, business, Lorlatinib, Real world data
Published
2021

11. Final PFS, updated OS and safety data from the randomised, phase III ALEX study of alectinib (ALC) versus crizotinib (CRZ) in untreated advanced ALK+ NSCLC

Author

Alice T. Shaw, Shirish M. Gadgeel, Maurice Pérol, Vlatka Smoljanovic, Magalie Hilton, Dai Woo Kim, Rafael Rosell, Walter Bordogna, R. Camidge, S.-H. Ou, Tony Mok, Solange Peters, and Rafal Dziadziuszko

Subjects
0301 basic medicine, Alectinib, Oncology, medicine.medical_specialty, Crizotinib, business.industry, Stock options, Hematology, Stage iiib, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Pharmacy (field), 030220 oncology & carcinogenesis, Visual accommodation, Internal medicine, Medicine, In patient, business, medicine.drug
Abstract

Background We report mature PFS, updated OS and safety data from the global phase III ALEX study (NCT02075840) of ALC vs CRZ in patients (pts) with untreated ALK+ NSCLC after a further 12 months (m) of follow-up (cutoff date: 30 Nov 2018). Methods Eligible pts had stage IIIB/IV ALK+ NSCLC (by central IHC), ECOG PS 0–2 and no prior systemic therapy for advanced NSCLC. Asymptomatic CNS metastases (mets) were allowed. Pts were randomised 1:1 to twice-daily ALC 600mg (n = 152) or CRZ 250mg (n = 151). Primary endpoint: investigator (INV)-assessed PFS (RECIST v1.1), with q8w CNS imaging in all pts. Results Mature, median INV-assessed PFS: 34.8 m (95% CI 17.7–NR) ALC vs 10.9 m (95% CI 9.1–12.9) CRZ (ITT stratified HR 0.43, 95% CI 0.32–0.58; p Conclusions This final updated PFS analysis confirms the superior efficacy and favourable tolerability of ALC compared with CRZ in pts with untreated ALK+ NSCLC. OS data remain immature (stratified HR 0.69, 95% CI 0.47–1.02), with a 4-year OS rate of 64.5% (95% CI 55.6–73.4) with ALC. Table . 1484PD PFS event-free rate, % (95% CI) OS event-free rate, % (95% CI) ALC (n = 152) CRZ (n = 151) ALC (n = 152) CRZ (n = 151) Duration (years) Overall Baseline CNS mets Overall Baseline CNS mets Overall Overall Yes No Yes No 1 67.8 (60.3–75.3) 58.5 74.5 48.0 (39.7–56.2) 32.5 57.2 84.3 (78.4–90.2) 82.5 (76.1–88.9) 2 56.6 (48.6–64.6) 52.0 59.8 24.8 (17.6–32.1) 6.3 35.7 72.5 (65.1–79.9) 65.1 (56.7–73.4) 3 46.4 (38.2–54.5) 40.5 50.6 13.5 (7.7–19.3) 2.1 20.2 66.9 (59.0–74.8) 56.7 (47.8–65.6) 4 43.7 (35.4–51.9) 38.0 47.6 NE (NE–NE) NE NE 64.5 (55.6–73.4) 52.2 (42.6–61.8) NE, not estimable Clinical trial identification NCT02075840. Editorial acknowledgement Nicola Griffin of Gardiner-Caldwell Communications; funded by F. Hoffmann-La Roche. Legal entity responsible for the study F. Hoffmann-La Roche Ltd. Funding F. Hoffmann-La Roche Ltd. Disclosure T.S.K. Mok: Leadership role: Sanonics Ltd.; Honoraria (self), Advisory / Consultancy: ACEA Biosciences, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Chimed, Cirina, Fishawack Facilitate, Ignyta, Janssen, Lilly, Merck Serono, Merck Sharp & Dohme, Novartis, OncoGenex, Pfizer, F. Hoffmann-La Roche Ltd/Genentech, SFJ Pharm; Research grant / Funding (self): AstraZeneca, Bristol-Myers Squibb, Clovis Oncology, Merck Sharp & Dohme, Novartis, Pfizer, F. Hoffmann-La Roche Ltd, SFJ Pharmaceutical and XCovery. A.T. Shaw: Honoraria (self), Advisory / Consultancy: F. Hoffmann-La Roche Ltd, Genentech, Pfizer, Novartis, Ariad, Ignyta, Daiichi-Sankyo, Taiho, Blueprint medicines, LOXO, EMD Serono and Foundation medicine. R.D. Camidge: Honoraria (self), Advisory / Consultancy: AbbVie, Ariad, Array, Celgene, Clovis Oncology, Eli Lilly, Genoptix, G1 Therapeutics, Novartis, Orion, and F. Hoffmann-La Roche Ltd/Genentech. S.M. Gadgeel: Honoraria (self), Advisory / Consultancy: Ariad, AstraZeneca, Bristol-Myers Squibb, Pfizer and F. Hoffmann-La Roche Ltd/Genentech. R. Dziadziuszko: Honoraria (self), Advisory / Consultancy: F. Hoffmann-La Roche Ltd, Pfizer, Boehringer Ingelheim, Clovis Oncology, Novartis, AstraZeneca and Tesaro. D. Kim: Travel / Accommodation / Expenses: F. Hoffmann-La Roche Ltd, Pfizer, Boehringer Ingelheim, Clovis Oncology, Novartis, AstraZeneca and Tesaro; Travel / Accommodation / Expenses: Novartis Oncology; Research grant / Funding (institution): Alpha Biopharma, AstraZeneca/MedImmune, Hanmi, Janssen, Merus, Mirati Therapeutics, MSD, Novartis, ONO Pharmaceutical, Pfizer, Roche/Genentech, Takeda, TP Therapeutics, Xcovery and Yuhan. M. Perol: Honoraria (self), Advisory / Consultancy: F. Hoffmann-La Roche Ltd/Genentech, Pfizer, Eli Lilly, Boehringer Ingelheim, Clovis Oncology, Merck Sharp & Dohme, Chugai, Bristol-Myers Squibb, Amgen, Novartis, Pierre Fabre, AstraZeneca, Takeda ; Research grant / Funding (institution): F. Hoffmann-La Roche Ltd, AstraZeneca, Chugai and Takeda. S. Ou: Honoraria (self): ARIAD, AstraZeneca, Pfizer, F. Hoffmann-La Roche Ltd/Genentech and TP Therapeutics; Speaker Bureau / Expert testimony: ARIAD, AstraZeneca and F. Hoffmann-La Roche Ltd/Genentech; Research grant / Funding (self): ARIAD, AstraZeneca, Daiichi Sankyo, Pfizer and F. Hoffmann-La Roche Ltd/Genentech; Shareholder / Stockholder / Stock options: TP Therapeutics. W. Bordogna: Full / Part-time employment: F. Hoffmann-La Roche Ltd. V. Smoljanovic: Full / Part-time employment: F. Hoffmann-La Roche Ltd. M. Hilton: Full / Part-time employment: F. Hoffmann-La Roche Ltd. S. Peters: Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): AbbVie, Amgen, AstraZeneca, Bayer, Biocartis, Boehringer Ingelheim, Bristol-Myers Squibb, Clovis, Daiichi Sankyo, Debiopharm, Eli Lilly, F. Hoffmann-La Roche Ltd, Foundation Medicine, Illumina, Janssen, Merck Sharp and Dohme, Merck Serono, Merrimack, Nova. All other authors have declared no conflicts of interest.

Published
2019

12. Safety and preliminary clinical activity of repotrectinib in patients with advanced ROS1/TRK fusion-positive solid tumors (TRIDENT-1 study)

Author

R. Camidge, S.-H. Ou, Jessica J. Lin, Dai Woo Kim, Shanna Stopatschinskaja, Viola W. Zhu, Byoung Chul Cho, J.W. Lee, J. Jean Cui, Robert C. Doebele, A. Drilon, Alice T. Shaw, and David M. Hyman

Subjects
0301 basic medicine, medicine.medical_specialty, business.industry, Stock options, Hematology, Champions Oncology, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Overall response rate, Salivary gland tumor, Oncology, 030220 oncology & carcinogenesis, Family medicine, Tumor regression, Medicine, In patient, Turning point, business, Solid tumor
Abstract

Background Repotrectinib is a next-generation ROS1/TRK/ALK TKI with >90-fold potency versus crizotinib against ROS1 and >100-fold potency versus larotrectinib against TRK in engineered Ba/F3 cell proliferation assays. Preclinical studies demonstrate robust activity against all known ROS1/TRK resistance mutations, including the most common solvent-front mutations (SFM) ROS1 G2032R, TRKA G595R, and TRKC G623R/E. Methods In the ongoing phase 1 study (NCT03093116), TKI-naive and TKI-pretreated (≥1 TKI) pts with advanced ROS1, TRK, or ALK fusion+ solid tumors received repotrectinib. Endpoints include safety, PK, and confirmed overall response (cORR). Results As of 4-March-2019, 83 pts were treated with repotrectinib (dose levels from 40 mg QD to 200 mg BID under fasted/fed conditions). Most AEs were manageable and grade (gr) 1-2. The most common treatment-emergent AEs (found in > 30% of pts) were dizziness (57%), dysgeusia (51%), dyspnea (30%), and fatigue (30%). Four DLTs occurred and were manageable with dose modifications: gr3 dyspnea/hypoxia (n = 1); gr2 (n = 1) and gr3 (n = 1) dizziness at 160 mg BID, and gr3 dizziness (n = 1) at 240 mg QD. In ROS1+ NSCLC, the median number of prior TKIs was 1 (0-3); all TKI-naive and 77% of TKI-pretreated pts received prior chemotherapy. In 11 evaluable TKI-naive ROS1+ NSCLC pts, cORR by Blinded Central Review (BCR) was 82% (95% CI 48 - 98); median duration of response was not reached ((range 5.6 - 17.7+ months (mos)). In 18 ROS1+ NSCLC pts pretreated with 1 prior TKI, cORR by BCR was 39% (95% CI 17 – 64), and in 11 pts with 1 prior TKI at doses of 160 mg QD or above cORR was 55% (95% CI 23 - 83). All pts with ROS1 G2032R had tumor regression [cORR of 40% (n = 2/5)]. In 1 TKI-pretreated pt with ETV6-NTRK3+ and an acquired TRKC G623E-mutant salivary gland tumor, a cPR of 9.8 mos was achieved; the patient was treated for 17.9 mos. Enrollment continues. Updated data in ∼10 additional ROS1+ NSCLC and TRK+ solid tumor pts will be presented. Conclusions Repotrectinib was well tolerated and demonstrated encouraging overall clinical activity in pts with ROS1 fusion-positive NSCLC and TRK fusion-positive solid tumors. Clinical trial identification NCT03093116. Legal entity responsible for the study Turning Point Therapeutics Inc, San Diego, CA, USA. Funding Turning Point Therapeutics Inc, San Diego, CA, USA. Disclosure A. Drilon: Honoraria (self), Advisory / Consultancy: Ignyta/Genentech/Roche; Honoraria (self), Advisory / Consultancy: Loxo Oncology/Bayer/Lilly; Honoraria (self), Advisory / Consultancy: TP Therapeutics Inc; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Honoraria (self), Advisory / Consultancy: Blueprint Medicines; Honoraria (institution), Advisory / Consultancy: Takeda/Ariad/Milenium; Honoraria (self), Advisory / Consultancy: Helsinn; Honoraria (institution), Advisory / Consultancy: Beigene; Honoraria (self), Advisory / Consultancy: BergenBio; Honoraria (self), Advisory / Consultancy: Hengrui Therapeutics; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Exelixis; Honoraria (self), Advisory / Consultancy: Tyra Biosciences; Research grant / Funding (institution): Foundation Medicine; Licensing / Royalties: Wolters Kluwer; Travel / Accommodation / Expenses: Merck; Honoraria (self), Advisory / Consultancy: MORE Health; Honoraria (self), Advisory / Consultancy: Verastem; Travel / Accommodation / Expenses: Puma; Research grant / Funding (institution): Teva; Research grant / Funding (institution): GlaxoSmithKlein. B.C. Cho: Shareholder / Stockholder / Stock options: heraCanVac Inc; Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (self): Novartis; Honoraria (self), Research grant / Funding (self): Bayer; Honoraria (self), Research grant / Funding (institution): AtraZeneca; Honoraria (self), Research grant / Funding (institution): MOGAM Institute; Honoraria (self): Dong-A ST; Licensing / Royalties: Champions Oncology. J.J. Lin: Speaker Bureau / Expert testimony: TP Therapeutics Inc; Honoraria (institution): Chugai; Honoraria (institution): Boehringer-Ingelheim. V. Zhu: Shareholder / Stockholder / Stock options: TP Therapeutics Inc; Honoraria (self), Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Astra Zeneka; Honoraria (institution), Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Takeda; Honoraria (self): Biocept; Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Roche/Genentech. R.D. Camidge: Research grant / Funding (self): Takeda. S. Stopatschinskaja: Travel / Accommodation / Expenses, Shareholder / Stockholder / Stock options, Full / Part-time employment: TP Therapeutics Inc. J..J. Cui: Leadership role, Travel / Accommodation / Expenses, Shareholder / Stockholder / Stock options, Full / Part-time employment: TP Therapeutics Inc. D.M. Hyman: Advisory / Consultancy, Travel / Accommodation / Expenses: Chugai; Advisory / Consultancy: CytomX Therapeutics; Advisory / Consultancy: Boehringer Ingelheim; Advisory / Consultancy, Research grant / Funding (self): AstraZeneca; Advisory / Consultancy: Pfizer; Advisory / Consultancy, Research grant / Funding (self): Bayer; Advisory / Consultancy, Travel / Accommodation / Expenses: Genentech; Research grant / Funding (self): Puma Biotechnology; Research grant / Funding (self): Loxo. S. Ou: Advisory / Consultancy, Research grant / Funding (institution), Shareholder / Stockholder / Stock options: TP Therapeutics Inc; Shareholder / Stockholder / Stock options: Ignyta; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): AstraZeneca; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Ariad; Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony: Genentech/Roche; Honoraria (self), Research grant / Funding (institution): Ignyta; Honoraria (self): Novartis; Research grant / Funding (institution): Blueprint Medicine. A.T. Shaw: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Novartis; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Roche/Genentech; Honoraria (self): Foundation Medicine; Honoraria (self): Guardant Health; Advisory / Consultancy, Research grant / Funding (institution): Ariad; Advisory / Consultancy, Research grant / Funding (institution): Ignyta; Advisory / Consultancy: Blueprint Medicine; Advisory / Consultancy, Research grant / Funding (institution): Daiichi Sankyo; Advisory / Consultancy: EDM Serono; Advisory / Consultancy: Taiho Pharmaceutical; Advisory / Consultancy: KSQ Therapeutics; Advisory / Consultancy: Natera; Advisory / Consultancy: Loxo; Advisory / Consultancy: Takeda; Advisory / Consultancy: Bayer; Advisory / Consultancy: Chugai Pharm; Research grant / Funding (institution): TP Therapeutics. R.C. Doebele: Speaker Bureau / Expert testimony: Takeda; Advisory / Consultancy, Licensing / Royalties: Ignyta; Speaker Bureau / Expert testimony: AstraZeneca; Advisory / Consultancy: Bayer; Advisory / Consultancy: Genentech; Shareholder / Stockholder / Stock options: Roche; Research grant / Funding (institution), Licensing / Royalties: Rain Therapeutics; Licensing / Royalties: Abbott Molecular. All other authors have declared no conflicts of interest.

Published
2019

13. P1.01-78 The Incidence of Brain Metastases in ROS1-Rearranged Non-Small Cell Lung Cancer at Diagnosis and Following Progression on Crizotinib

Author

Tejas Patil, Paul A. Bunn, Derek E. Smith, Dara L. Aisner, M. Hancock, Daniel W. Bowles, R. Camidge, Anh T. Le, William T. Purcell, and Robert C. Doebele

Subjects
Pulmonary and Respiratory Medicine, Oncology, medicine.medical_specialty, Crizotinib, business.industry, Incidence (epidemiology), medicine.disease, Internal medicine, medicine, ROS1, Non small cell, business, Lung cancer, medicine.drug
Published
2018

14. PL02.03 Brigatinib vs Crizotinib in Patients With ALK Inhibitor-Naive Advanced ALK+ NSCLC: First Report of a Phase 3 Trial (ALTA-1L)

Author

Scott N. Gettinger, J. Haney, M.R. Garcia Campelo, J-S. Lee, R. Camidge, K.H. Lee, Hwa Ryeon Kim, Cesare Gridelli, G-C. Chang, Alexander I. Spira, M-J. Ahn, M. Tiseo, Enriqueta Felip, Maximilian Hochmair, Raffaele Califano, S. Ghosh, Alessandra Bearz, J.Y. Li, Frank Griesinger, Dong Wook Kim, J.C.-H. Yang, David Kerstein, Alessandro Morabito, Sanjay Popat, J-Y. Han, and Angelo Delmonte

Subjects
Pulmonary and Respiratory Medicine, ALK inhibitor, Oncology, Brigatinib, Crizotinib, business.industry, medicine.drug_class, Cancer research, medicine, In patient, business, medicine.drug
Published
2018

16. Talactoferrin alfa versus placebo in patients with refractory advanced non-small-cell lung cancer (FORTIS-M trial)

Author

S. Ramalingam, J. Crawford, A. Chang, C. Manegold, R. Perez-Soler, J.-Y. Douillard, N. Thatcher, F. Barlesi, T. Owonikoko, Y. Wang, P. Pultar, J. Zhu, R. Malik, G. Giaccone, S. Della-Fiorentina, S. Begbie, R. Jennens, J. Dass, K. Pittman, N. Ivanova, T. Koynova, P. Petrov, A. Tomova, V. Tzekova, F. Couture, V. Hirsh, R. Burkes, R. Sangha, M. Ambrus, T. Janaskova, J. Musil, J. Novotny, P. Zatloukal, J. Jakesova, K. Klenha, J. Roubec, J. Vanasek, J. Fayette, J. Bennouna-Louridi, C. Chouaid, J. Mazières, H. Vallerand, G. Robinet, P.-J. Souquet, D. Spaeth, R. Schott, H. Lena, Y. Martinet, C. El Kouri, N. Baize, A. Scherpereel, O. Molinier, F. Fuchs, K.M. Josten, N. Marschner, F. Schneller, T. Overbeck, M. Thomas, J. von Pawel, M. Reck, W. Schuette, V. Hagen, C.-P. Schneider, V. Georgoulias, I. Varthalitis, K. Zarogoulidis, K. Syrigos, C. Papandreou, C. Bocskei, E. Csanky, E. Juhasz, G. Losonczy, Z. Mark, I. Molnar, Z. Papai-Szekely, S. Tehenes, I. Vinkler, S. Almel, A. Bakshi, S. Bondarde, A. Maru, A. Pathak, R.M. Pedapenki, K. Prasad, S.V.S.S. Prasad, N. Kilara, D. Gorijavolu, C.D. Deshmukh, S. John, L.M. Sharma, D. Amoroso, E. Bajetta, P. Bidoli, A. Bonetti, F. De Marinis, M. Maio, R. Passalacqua, S. Cascinu, A. Bearz, M. Bitina, A. Brize, G. Purkalne, M. Skrodele, A.A. Baba, K. Ratnavelu, M.H. Saw, M.C. Samson-Fernando, G.E. Ladrera, J. Jassem, P. Koralewski, P. Serwatowski, M. Krzakowski, C. Cebotaru, D. Filip, D.E. Ganea-Motan, C.H. Ianuli, I.G. Manolescu, A. Udrea, O. Burdaeva, M. Byakhov, A. Filippov, S. Lazarev, I. Mosin, S. Orlov, D. Udovitsa, A. Khorinko, S. Protsenko, H.L. Lim, Y.O. Tan, E.H. Tan, R. Bastus Piulats, J. Garcia-Foncillas, J. Valdivia, J. de Castro, M. Domine Gomez, S.W. Kim, J.-S. Lee, H.K. Kim, J.S. Lee, S.W. Shin, D.-W. Kim, Y.-C. Kim, K.C. Park, C.-S. Chang, G.-C. Chang, Y.-G. Goan, W.-C. Su, C.-M. Tsai, H.-P. Kuo, M. Benekli, G. Demir, E. Gokmen, A. Sevinc, M. Haigentz, M. Agarwal, S. Pandit, R. Araujo, N. Vrindavanam, P. Bonomi, A. Berg, J. Wade, R. Bloom, B. Amin, R. Camidge, D. Hill, M. Rarick, P. Flynn, L. Klein, K. Lo Russo, M. Neubauer, P. Richards, R. Ruxer, M. Savin, D. Weckstein, R. Rosenberg, T. Whittaker, D. Richards, W. Berry, C. Ottensmeier, A. Dangoor, N. Steele, Y. Summers, E. Rankin, K. Rowley, S. Giridharan, H. Kristeleit, C. Humber, P. Taylor, Ramalingam, S, Crawford, J, Chang, A, Manegold, C, Perez-Soler, R, Douillard, J, Thatcher, N, Barlesi, F, Owonikoko, T, Wang, Y, Pultar, P, Zhu, J, Malik, R, Giaccone, G, and Bidoli, P

Subjects
Male, medicine.medical_specialty, Population, Kaplan-Meier Estimate, Placebo, Gastroenterology, Disease-Free Survival, Drug Administration Schedule, Placebos, Double-Blind Method, Talactoferrin Alfa, Carcinoma, Non-Small-Cell Lung, Internal medicine, Talactoferrin, Humans, Medicine, Phase III study, Progression-free survival, education, Lung cancer, Survival rate, Aged, Neoplasm Staging, education.field_of_study, business.industry, Surrogate endpoint, Hazard ratio, Hematology, Middle Aged, medicine.disease, Surgery, oral dendritic cell (DC)-mediated immunotherapy, Lactoferrin, Treatment Outcome, Oncology, Female, Immunotherapy, Immunotherapy, Non-small-cell lung cancer, Phase III study, Talactoferrin, business, Non-small-cell lung cancer
Abstract

Background Talactoferrin alfa is an oral dendritic cell (DC)-mediated immunotherapy (DCMI). We tested whether talactoferrin was superior to placebo in advanced non-small-cell lung cancer (NSCLC). Patients and methods An FORTIS-M trial was an international, multicenter, randomized, double-blind comparison of talactoferrin (1.5g p.o. BID) versus placebo BID, in patients with stage IIIB/IV NSCLC whose disease had failed two or more prior regimens. Treatment was administered for a maximum of five 14-week cycles. The primary efficacy end point was overall survival (OS); secondary end points included 6- and 12-month survival, progression-free survival (PFS), and disease control rate (DCR). Results Seven hundred and forty-two patients were randomly assigned (2:1) to talactoferrin (497) or placebo (245). The median OS in the intent-to-treat (ITT) population was 7.66 months in the placebo arm and 7.49 months in the talactoferrin arm [hazard ratio (HR), 1.04; 95% CI, 0.873–1.24; P = 0.6602]. The 6-month survival rates were 59.9% (95% CI, 53.4% to 65.8%) and 55.7% (95% CI, 51.1% to 59.9%), respectively. The 12-month survival rates were 32.2% (95% CI, 26.3% to 38.2%) and 30.9% (95% CI, 26.8% to 35%), respectively. The median PFS rates were 1.64 months and 1.68 months, respectively (HR, 0.99; 95% CI, 0.835–1.16; P = 0.8073). The DCRs were 38.4 and 37.6%, respectively [stratified odds ratio (OR), 0.96; 95% CI, 0.698–1.33; P = 0.8336]. The safety profiles were comparable between arms. Conclusions There was no improvement in efficacy with talactoferrin alfa in patients with advanced NSCLC whose disease had failed two or more previous regimens.

Published
2013

17. P1.01-62 The Third Generation Irreversible EGFR Inhibitor HS-10296 in Advanced Non-Small Cell Lung Cancer Patients

Author

R. Camidge, Naveed Chowhan, Renhua Guo, Ajit Maniam, J. Zhou, Chun Chih Chiu, Shun Lu, W. Su, Mohammad Jahanzeb, Hongming Pan, Nehal Masood, T. Hsia, David Berz, H. Shiah, Zhijie Wang, Yilu Lu, Maurice Willis, Keisuke Shirai, Jianhua Chen, C.-T. Yang, Jian Fang, G-C. Chang, Nong Yang, Yuan Chen, Lyudmilla Bazhenova, J.C.-H. Yang, Petros Nikolinakos, and Wang Cc

Subjects
0301 basic medicine, Pulmonary and Respiratory Medicine, business.industry, medicine.disease, Third generation, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Oncology, 030220 oncology & carcinogenesis, medicine, Cancer research, Non small cell, Lung cancer, business, EGFR inhibitors
Published
2018

18. OA02.02 Safety and Preliminary Clinical Activity of Ropotrectinib (TPX-0005), a ROS1/TRK/ALK Inhibitor, in Advanced ROS1 Fusion-Positive NSCLC

Author

Alice T. Shaw, Byoung Chul Cho, J. Lim, M-J. Ahn, A. Drilon, Viola W. Zhu, David M. Hyman, S-H.I. Ou, J.W. Lee, Robert C. Doebele, R. Camidge, Jessica Lin, D. Kim, J. Jean Cui, and Shanna Stopatschinskaja

Subjects
0301 basic medicine, Pulmonary and Respiratory Medicine, medicine.drug_class, business.industry, ROS1 Fusion Positive, ALK inhibitor, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Oncology, 030220 oncology & carcinogenesis, Trk receptor, medicine, ROS1, Cancer research, business
Published
2018

19. An open-label, multicenter, phase I study of ABBV-399 (telisotuzumab vedotin, teliso-V) as monotherapy (T) and in combination with erlotinib (T+E) in non-small cell lung cancer (NSCLC)

Author

Eric Angevin, Jonathan H. Goldman, Karen Kelly, Everett E. Vokes, Todd M. Bauer, Apurvasena Parikh, John H. Strickler, Monica Motwani, T. Yi, Daniel Morgensztern, Rebecca S. Heist, J. Wu, R. Camidge, and Minal A. Barve

Subjects
Oncology, medicine.medical_specialty, business.industry, non-small cell lung cancer (NSCLC), Hematology, medicine.disease, Phase i study, Internal medicine, medicine, Erlotinib, Open label, business, medicine.drug
Published
2018

20. OA12.06 Mutational Landscape of BRAF V600E Positive Lung Cancer Patients Following BRAF Directed Therapy Failure

Author

A. Dimou, T. Ng, A. Chalmers, M. Devitt, A. Le, V. Malhotra, R. Hall, T. Rich, W. Akerley, J. Zhang, D. Aisner, R. Camidge, and R. Doebele

Subjects
0301 basic medicine, Pulmonary and Respiratory Medicine, Oncology, medicine.medical_specialty, business.industry, medicine.disease, BRAF V600E, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, 030220 oncology & carcinogenesis, Internal medicine, medicine, Lung cancer, business
Published
2018

22. Alectinib vs crizotinib in treatment-naïve ALK+ NSCLC: CNS efficacy results from the ALEX study

Author

Eveline Nueesch, Bogdana Balas, Joonghyun Ahn, Solange Peters, S-H.I. Ou, Emmanuel Mitry, D-W. Kim, Tony Mok, R. Camidge, Rafal Dziadziuszko, Rafael Rosell, Maurice Pérol, Alice T. Shaw, Ali Zeaiter, and S. Gadgeel

Subjects
0301 basic medicine, Oncology, medicine.medical_specialty, Crizotinib, business.industry, Hematology, Therapy naive, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, 030220 oncology & carcinogenesis, Internal medicine, medicine, Intensive care medicine, business, medicine.drug
Published
2017

23. Summary of Selected Presentations from the 8th Annual Targeted Therapy in Lung Cancer Symposium

Author

David P. Johnson, Karen Kelly, M. Tsao, Roy S. Herbst, R. Camidge, Laurie E. Gaspar, Ramaswamy Govindan, George R. Simon, Paul A. Bunn, Glennwood Goss, Suresh S. Ramalingam, Karen L. Reckamp, and Howard Jack West

Subjects
Diagnostic Imaging, Oncology, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Lung Neoplasms, medicine.medical_treatment, Cancer therapy, Treatment of lung cancer, Targeted therapy, Breast cancer, Internal medicine, Biomarkers, Tumor, Humans, Medicine, Lung cancer, business.industry, Myeloid leukemia, Genomics, Congresses as Topic, respiratory system, Cytotoxic chemotherapy, medicine.disease, Molecularly targeted therapy, Immunology, Molecular targets, business
Abstract

Lung cancer is the leading cause of cancer-related death in the United States. Outcomes for patients with lung cancer have reached a plateau with cytotoxic chemotherapy. Lung cancer remains very much at the vanguard of the new revolution in cancer therapy using molecular targets. Although striking improvements in survival have been observed in the treatment of chronic myeloid leukemia, gastrointestinal stromal tumors, and in a subset of breast cancer using this approach, the impact of targeted therapies in lung cancer is quite modest. Along with advances in imaging and cancer genomics, there is now considerable optimism that the pace of progress in the treatment of lung cancer will accelerate in the next 10 years. As has been the custom for the past 8 years, leading experts in the biology, diagnosis and treatment of lung cancer met for three days to discuss current areas of research and future directions. This summary provides a brief snapshot of the discussions held at the 8th Annual Meeting on Targeted Therapies for Lung Cancer sponsored by the International Association for the Study of Lung Cancer in Santa Monica in early February 2008.

Published
2009
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24. Continued Afatinib (A) With the Addition of Cetuximab (C) After Progression on Afatinib in Patients With Acquired Resistance (AR) to Gefitinib (G) or Erlotinib (E)

Author

Harry J.M. Groen, William Pao, Scott N. Gettinger, Vikram K. Chand, Bushi Wang, Egbert F. Smit, R. Camidge, Yelena Y. Janjigian, D. Schnell, and Leora Horn

Subjects
Oncology, Cancer Research, medicine.medical_specialty, Radiation, Cetuximab, business.industry, Afatinib, Gefitinib, Acquired resistance, Internal medicine, medicine, Radiology, Nuclear Medicine and imaging, In patient, Erlotinib, business, medicine.drug
Published
2014

25. Alk Inhibitor Ap26113 in Patients with Advanced Malignancies, Including Alk+ Non-Small Cell Lung Cancer (Nsclc): Updated Efficacy and Safety Data

Author

Alice T. Shaw, Lyudmila Bazhenova, Narayana I. Narasimhan, Glen J. Weiss, David J. Dorer, Scott N. Gettinger, Kathryn A. Gold, Ravi Salgia, Frank G. Haluska, Corey J. Langer, Victor M. Rivera, R. Camidge, Rafael Rosell, and Timothy P. Clackson

Subjects
Oncology, medicine.medical_specialty, Brigatinib, Crizotinib, Nausea, medicine.drug_class, business.industry, non-small cell lung cancer (NSCLC), Hematology, medicine.disease, Tyrosine-kinase inhibitor, Surgery, Internal medicine, medicine, Vomiting, Progression-free survival, medicine.symptom, Adverse effect, business, medicine.drug
Abstract

Aim: AP26113 is an investigational orally-active tyrosine kinase inhibitor with preclinical activity against ALK and all 9 clinically-identified crizotinib-resistant mutants tested. Methods: The Phase (Ph) 2 portion of a Ph1/2 single arm, multicenter study in patients (pts) with advanced malignancies is underway. We report updated safety for all treated pts and efficacy data for ALK+ NSCLC pts previously treated with crizotinib. NCT01449461. Results: As of 17 March 2014, 125 pts were enrolled: 66 in Ph1 (30-300 mg) and 59 in Ph2 (90 or 180 mg). Baseline characteristics: 58% female, median age 57 yr; diagnoses: NSCLC n = 117, other n = 8. 62 pts remain on study; median follow-up for all pts is 3.1 mo (max= 24.4 mo, ongoing). The most common treatment-emergent adverse events (≥20%) were nausea (40%), fatigue (34%), diarrhea (34%), cough (26%), headache (25%), and vomiting (21%), which were generally Grade 1/2 in severity. Early onset pulmonary symptoms (dyspnea with hypoxia and/or new findings on chest imaging) were observed in 12/125 (10%) pts: 6/44 (14%) at 180 mg qd and 1/38 (3%) at 90 mg qd. Symptoms occurred within 7 days following initiation of AP26113, required medical attention, and occurred at lower rates with lower doses. Pts continue to be enrolled at 90 mg qd. Among 51 evaluable ALK+ NSCLC pts with prior crizotinib, 35 (69%) responded. Duration of response was 1.6– 14.7+ mo. 23 had confirmed responses and 7 await confirmation. Among 55 evaluable pts with ALK+ NSCLC, median progression free survival is 10.9 mo. Independent radiological review conducted on 10 pts enrolled with untreated or progressing brain metastases showed 6/10 pts with regression in brain, including 4 with undetectable brain metastases following AP26113; 2 had stable disease, 2 progressed; 7/10 remain on study (range 2.7-19.5 mo). Updated data will be presented. Conclusions: AP26113 has promising anti-tumor activity in pts with crizotinib-resistant ALK+ NSCLC, including pts with brain metastases. A randomized Ph2 trial evaluating either 90 mg qd or 90mg qd escalated to 180 mg qd in crizotinib-resistant ALK+ NSCLC has been initiated. Disclosure: S. Gettinger: research funding (ARIAD); consultancy (ARIAD); honoraria (ARIAD); C. Langer: research funding (ARIAD); A. Shaw: consultancy (ARIAD); G.J. Weiss: consultancy (Genentech, Pfizer, Celgene, Quintiles, Medscape); N.I. Narasimhan: employment and equity ownership (ARIAD); D.J. Dorer: employment and equity ownership (ARIAD); V.M. Rivera: employment and equity ownership (ARIAD); T. Clackson: employment and equity ownership (ARIAD); F.G. Haluska: employment and equity ownership (ARIAD); R. Camidge: research funding (ARIAD); honoraria (ARIAD). All other authors have declared no conflicts of interest.

Published
2014

26. Crizotinib Treatment in Patients (PTS) with Advanced ROS1-Rearranged Non-Small Cell Lung Cancer (NSCLC)

Author

Alice T. Shaw, L. Tye, R. Camidge, S-H.I. Ou, John W. Clark, Ravi Salgia, Anthony J. Iafrate, Gregory J. Riely, Geoffrey I. Shapiro, and Dong Wan Kim

Subjects
Brachial Plexus Neuritis, Oncology, medicine.medical_specialty, Crizotinib, business.industry, non-small cell lung cancer (NSCLC), Hematology, medicine.disease, Internal medicine, ROS1, medicine, In patient, business, medicine.drug
Published
2013

27. Phase III Study of Crizotinib Versus Pemetrexed or Docetaxel Chemotherapy in Patients with Advanced Alk-Positive Non-Small Cell Lung Cancer (NSCLC) (Profile 1007)

Author

V. Tassell, Denis Moro-Sibilot, Y-L. Wu, Anna Polli, M-J. Ahn, Fiona H Blackhall, Benjamin Besse, Kazuhiko Nakagawa, R. Camidge, T. De Pas, Dong Wook Kim, Alice T. Shaw, Ben Solomon, Kenneth J. O'Byrne, L. Crinò, Tony Mok, Michael Thomas, Takashi Seto, Vera Hirsh, and Pasi A. Jänne

Subjects
Oncology, medicine.medical_specialty, Chemotherapy, Crizotinib, business.industry, medicine.medical_treatment, ALK-Positive, non-small cell lung cancer (NSCLC), Hematology, medicine.disease, Pemetrexed, Docetaxel, Internal medicine, medicine, Anaplastic lymphoma kinase, In patient, business, medicine.drug
Abstract

Background Chromosomal rearrangements of anaplastic lymphoma kinase (ALK) are associated with marked clinical responses to crizotinib, an orally available tyrosine kinase inhibitor targeting ALK. This global randomized phase III study compared the efficacy and safety of crizotinib (C) with standard chemotherapy (pemetrexed or docetaxel [P/D]) as 2nd-line therapy for patients (pts) with advanced ALK+ NSCLC. Methods Between Feb 2010 and Feb 2012, 347 pts with stage IIIB/IV ALK+ NSCLC previously treated with 1 prior platinum-based regimen were randomized to receive C 250 mg PO BID (n = 173) or either P 500 mg/m2 or D 75 mg/m2 IV q3w (n = 174; 58% P, 42% D). ALK was detected by FISH in a central lab. Pts with progressive disease on P/D were offered C on PROFILE 1005. The primary endpoint was progression-free survival (PFS) per independent radiologic review; secondary endpoints included objective response rate (ORR), overall survival (OS), safety, and patient-reported outcomes. Results The study met its primary objective by demonstrating the superiority of C over P/D in prolonging PFS (median 7.7 vs 3.0 mo; HR 0.49; 95% CI 0.37–0.64; P Conclusions C showed significant improvement in PFS and ORR compared with P/D and had an acceptable safety profile. These findings establish C as the standard of care for pts with previously treated advanced ALK+ NSCLC. Disclosure A.T. Shaw: Advisory relationship with Pfizer, Ariad, Chugai, Novartis and Daiichi-Sankyo. Research funding from AstraZeneca and Novartis. D.W. Kim: Advisory relationship with Pfizer. Honoraria from Pfizer. K. Nakagawa: Honoraria from Pfizer and Eli Lilly. B. Besse: Research funding from Pfizer. B. Solomon: Advisory relationship with Pfizer. Research funding from Pfizer. F.H. Blackhall: Advisory relationship with Pfizer. Honoraria from Pfizer. Research funding from Pfizer. Expert testimony for UK NICE scoping for crizotinib. Y. Wu: Honoraria from Pfizer, Roche, AstraZeneca, Eli Lilly, and Sanof-Aventis. Research funding from Pfizer, Roche, and AstraZeneca. M. Thomas: Advisory relationship with Pfizer. K.J. O'Byrne: Adivsory relationships with and honoraria, research funding, travel-cost remuneration from Pfizer and Eli Lilly. D. Moro-Sibilot: Honoraria from Pfizer. R. Camidge: Advisory relationship with Pfizer. Honoraria from Pfizer. V. Hirsh: Advisory relationship with Pfizer. Honoraria from Pfizer. T.S.K. Mok: Advisory relationships with and honoraria from Pfizer, AstraZeneca, Roche, Eli Lilly, Merck Serono, Eisai, BMS, BeiGene, AVEO, Taiho, GSK, and Boehringer Ingelheim. Research funding from AstraZeneca. V. Tassell: Employed by Pfizer. Holds Pfizer stock. A. Polli: Employed by Pfizer. Holds Pfizer stock. P. Janne: Advisory relationships with Pfizer, Boehringer Ingelheim, Roche, Genentech, Abbott, AstraZeneca, Sanofi, and Teva. Renumeration from LabCorp. All other authors have declared no conflicts of interest.

Published
2012

28. Association Between Tumor Egfr and Kras Mutation Status and Clinical Outcomes in Nsclc Patients Randomized to Sorafenib Plus Best Supportive Care (BSC) or Bsc Alone: Subanalysis of the Phase III Mission Trial

Author

Chris Twelves, J. Thompson, C. Fernández, H. Bonnefoi, Robert Jones, R. de Wit, Yves Humblet, C. Boni, T. Seto, P. Rougier, I.T. Rubio, S. McMahon, V. Patel, David Gentien, A. Santoro, José Baselga, M. Barrié, E. Ciruelos, R.A. Madan, U. Jungnelius, E. Esteban, H. Abbas, C. Robert, J. Martin, F. Selle, Dong Wook Kim, H. Singh-Jasuja, Arthur L. Klatsky, Harald A. Weber, A. Bonetti, Florence Lerebours, A. Hamed, Georgina V. Long, Véronique Diéras, A. Savarese, E.M. Guerra, Richard Bell, Nick Thatcher, M.S.L. Teng, Toni K. Choueiri, M. Untch, Nicole M. Kuderer, H-J. Lenz, D. Serin, A. Fandi, Frédéric Commo, Y-L. Wu, A.S. Daud, Kazuhiko Nakagawa, Debora Barton, D. Brewer, G. Folprecht, Frank Cihon, Michael Thomas, M. Fleischer, T. Nakajima, Mary Anne Armstrong, Jonathan Cebon, M. Rios, L. Gissmann, P. Preux, A. Loundou, Lluis M. Mir, F. Lordick, Lynn M. Schuchter, B. Vasseur, Ulrika Harmenberg, B. Massuti Sureda, M. Matta, X. Durando, C. Costa, J-P. Guastalla, Brigitte Sigal-Zafrani, S. Falk, Nicolas Servant, M. Campone, Richard M. Goldberg, Petronella O. Witteveen, A. Grothey, T. Olive, Andrea Wagner, L. Crinò, R. Rosell, T. De Pas, P. Attali, Mitchell Dowsett, M. Lacroix, Y. Xu, F. Hilpert, Benjamin Solomon, Enriqueta Felip, A. Pasic, D. Genet, A. Falcone, A. Niethammer, K. Tauer, D. Berton-Rigaud, L. Bedenne, Enrico Mini, J-P. Jacquin, J.-L. Van Laethem, Egbert F. Smit, R.J. Jones, David Cella, K. Pittman, W. Hwu, D. Bollag, Yan Li, Roma Parikh, P.J. Wiechno, C. Jouannaud, Masahiro Takeuchi, P. Slaouti, Eric Pujade-Lauraine, A. Sobrero, C. Campello, H. Y. Lim, Ellie Guardino, L.S. Schwartzberg, Margarita Majem, F. Dalenc, Bruno R. Bastos, P. Senico, J.S. de Bono, Olivier Rosmorduc, Bernard Asselain, J. Atkins, C. Centeno, F. Subtil, H.J.M. Groen, F. Bonnetain, Benjamin Besse, Sarah Pearson, N. Vogelzang, J.T. Hartmann, Susan J Dutton, B. Zaric, G.A. Bjarnason, S. Olsen, L. Jia, Jun Guo, L. Venat-Bouvet, R. D. Gelber, Silvia Novello, Etienne Brain, Carlo Barone, S. Lavau-Denes, S. Zhu, C.N. Sternberg, Roman Perez-Soler, V. Tassell, D. Frappaz, C. Cremolini, J. Clancy, D. Wan, G. Masi, M. Jensen, Richard F. Kefford, Michael Baum, D. Lu, A. Gonzalez Martin, Alain Algazi, C. Valsuani, A. Maubon, C. Heery, L. Cupit, R.J. Motzer, P. Kerbrat, N. Gadea, A. P. Dei Tos, C.S. Cooper, Ricardo J. Gonzalez, A. Vuorela, A. Gonçalves, H. Tan, Thomas E. Hutson, G. Goss, M. Frenay, M. Munill, R. Kudchakar, J. Schlom, L. Mineur, Max Bulsara, J. Wei, Y. Wang, T.J. Ong, Wasaburou Koizumi, Michael Staehler, F. Ghiringhelli, F. Barlesi, C. Mermel, M. Provansal, David R. Spigel, Bernard Escudier, C. Granetto, Trever G. Bivona, Gerold Meinhardt, Jaime R. Merchan, A. Chatterjee, L. Salvatore, Suzette Delaloge, D. Laurent, J. Clark, Fabrice Andre, I. Ray-Coquard, P. Salman, Peng Sun, S. Hodge, M. Schneider, Petr Kavan, B. Biesma, Paul Ross, A. Gimenez-Capitan, T. Schmelter, J. Ritchie, Jean-Yves Pierga, W. Mansoor, R. Hubner, C. Girault, S. Di Cosimo, D.W. Fyfe, G. Allegrini, Yang Sun, S. Burgers, J. Reeves, P. Mulholland, B. Chauffert, S.M. Steinberg, David R. Ferry, H.C. Chung, N. Budnik, Sang Cheul Oh, R. Gervais, M.A. Molina, Iben Spanggaard, X. Pivot, Anna C. Pavlick, Jeffrey Crawford, M. Schirripa, K. Fife, M. Davoudianfar, Alexander Reuss, C. Sonaglio, Elena Castro, Nicholas Choong, A. Kramar, I. Chan, J. Ferrero, M. Snoj, L. Peachey, Jaap Verweij, I. El-Hariry, H.A. Azim, E. Tabouret, P. Arlen, Ian Judson, M. Praet, J.C-H. Yang, D.G. Power, R. Schott, N. Karachaliou, R. Midgely, Lei Zhang, L. Paz-Ares, W.T.A. van der Graaf, J. Labourey, Andrew X. Zhu, H. Wang, A.D. Vincent, Chris Parker, Masashi Fujii, Hirotsugu Uemura, M-J. Ahn, J. Mehta, Lauren McCann, Samar Alsafadi, A.M. Poveda, Y. Lou, S. Peoples, K. Sivarajan, S. Chiara, P. Fumoleau, O. Aren, G. McArthur, J. Zhu, Julie Gehl, P. Laurent-Puig, Martine Piccart, J. Evans, Laurence Collette, K. B. Kim, Jeffrey S Tobias, J. A. Sosman, Carol Peña, Frederik Wenz, A. Goldhirsch, F. Teofilovici, J. Thaler, Jose Leal, P. Giannikopoulos, Mark A. Socinski, Patrick Julier, L. Boni, L. Cany, C. Boucard, Ludovic Lacroix, A. Dahle-Smith, Y-K. Kang, Yi-Long Wu, Ian E. Krop, C. Heredia, O. Ishibashi, M. Santarpia, Aoife M. Ryan, B. Leyland-Jones, Paul Nathan, A-M.C. Dingemans, F.H. Blackhall, Anna Polli, C. Lepage, L. Antonuzzo, S. Cushen, D-Y. Oh, C. Dalban, A. Mori, M. Espié, V. Semiglazov, MA LeBerre, J. Adelaide, Natalia Udaltsova, Nuhad K. Ibrahim, Richard Sullivan, D.A. Fennell, J. Skrzypski, G. Romieu, H. Eidtmann, J. Bosch-Barrera, Taofeek K. Owonikoko, M. DeSilvio, C. Jackisch, Robert J. Motzer, G. Sersa, F. Boudouresque, Russell D. Petty, S. Jefferies, T. Moran Bueno, M.O. Palumbo, M. Ouafik, J. Balmana, D. Valcárcel, S. Cupini, G. Bodoky, S. Szyldergemajn, A. Fabi, M. Cardoso, R. Allerton, U. Kenny, O. Chinot, Daniel J. Sargent, U. De Giorgi, Mark D. Pegram, J. M. Del Campo, J. Surralles, H. Oltean, A. Garcia-Alonso, Kensaku Yoshida, E. Juhasz, Howard I. Scher, H. Goette, David Baer, L. Fornaro, D. Cameron, Nicholas D. James, Thomas F. Gajewski, P. Lacroix, M. Harrison, G.D. Friedman, A. Enke, C. Bouquet, I. Bradbury, S. Halford, M. Jimenez, A. Chang, J-Y Pierga, P. Pultar, T. Bachelot, Daniel C. Danila, L. Eckert, J. Douillard, L. Burns, F. De Marinis, David Miles, Q. Wang, A. Vergnenegre, D. Khayat, F.J. Carrilho, H. Codrington, K. Wang, D. Moro-Sibilot, N. Bosch, J.L. Quesada, M.D. Dibonaventura, E. de Azambuja, S. Abadie-Lacourtoisie, Christophe Massard, L. Fang, I. Pauporte, L. Feuvret, C. Manegold, Ramon Luengo-Fernandez, M. Banzi, J.S. Guillamo, B. Żurawski, Suresh S. Ramalingam, J.L. Gulley, M. Liu, M. Ychou, O. Al-Salihi, T. Hutson, S. Santillana, Alice T. Shaw, I.E. Smith, S. Culine, H. Tailla, Kiran Patel, Patrick Schöffski, Adil Daud, Luca Gianni, R. Camidge, A. Lortholary, M. Lu, L. Taillandier, A. James, M. Procter, Carmen Criscitiello, Mika Mustonen, R. Rampling, Jayant S. Vaidya, D. Agbor-Tarh, T. Gamble, Subramanian Hariharan, Andrea Cavalcanti, R. Malik, Ignace Vergote, Sandrine Marreaud, Heather A. Wakelee, Shonda M Little, Hans Gelderblom, M. Arnedos Ballester, J. Tabernero, J. Honnorat, S. Li, O. Bouché, Isabelle Gilloteau, A. Goren, J.G. Aerts, J. Blay, W. Eiermann, D. Joseph, Jie Jin, J.F. Emile, Gerhardt Attard, Markus Moehler, Yang Hyun Kim, S. Verma, Nicole Tubiana-Mathieu, J. Taieb, G. Giaccone, Shahneen Sandhu, Kenneth J. O'Byrne, E. Van Cutsem, T. Yoshino, Saskia Litière, Keith T. Flaherty, J. R. Infante, Chetan Lathia, V. Vukovic, E. Giommoni, Alison Reid, S. Siena, Keith C. Deen, Tony Mok, J. Wang, J.S. Weber, Corey J. Langer, E. Fea, P. de Souza, C. Levy, K. Kumari, A. Casado, M. Welslau, Karl D. Lewis, O. Dalesio, R. Swaby, M. Fabbro, Brian I. Rini, Janusz Jankowski, Daniel P. Petrylak, Robert E. Hawkins, M. Mohebtash, A. Adenis, A. Ribas, Igor Puzanov, I. Tennevet, H. Kim, Karim Fizazi, O. Hamid, D. Olmos Hidalgo, J.A. Bridgewater, S. Catala, H. Melezinkova, G. Kurteva, Aristotle Bamias, F. Loupakis, Vera Hirsh, Pasi A. Jänne, Kimberly L. Blackwell, M.R. Garcia-Campelo, C. Kahatt, J. Bellmunt, and J. Alexandre

Subjects
Oncology, Sorafenib, medicine.medical_specialty, Proportional hazards model, business.industry, Hematology, medicine.disease_cause, Placebo, medicine.disease, Breast cancer, Egfr mutation, Internal medicine, Medicine, Biomarker (medicine), KRAS, Stage (cooking), business, medicine.drug
Abstract

Background Tumor EGFR and KRas mutations are both predictive and prognostic biomarkers in patients with advanced NSCLC. We analyzed the correlation between these biomarkers and treatment outcomes in a phase III trial of 3rd/4th line sorafenib in patients with NSCLC. Methods The global, randomized, placebo-controlled MISSION trial enrolled 703 patients with advanced relapsed/refractory NSCLC of predominantly non-squamous histology. The primary study endpoint was overall survival (OS). EGFR and KRas mutations were analyzed in archival tumor samples and in circulating tumor DNA isolated from plasma. Results Tumor and/or plasma mutation data were available from 347 patients (49%). EGFR and KRas mutations were detected in 89 (26%) and 68 (20%) patients, respectively, and were well balanced between treatment arms. Analysis of the interaction between EGFR mutation status and treatment effect on survival suggested that patients with EGFR mutations (mEGFR) benefitted from sorafenib, while those with wild-type EGFR (wtEGFR) did not (p = 0.023). Median OS was two-fold longer in mEGFR patients receiving sorafenib versus placebo (423 vs 197 days, HR 0.48, p = 0.002). There was no significant difference in OS between patients with wtEGFR receiving sorafenib or placebo (253 vs 256 days, HR 0.92, p = 0.559). An interaction was also seen between EGFR mutation status and the sorafenib effect on PFS (p = 0.015). Patients with mEGFR treated with sorafenib had better outcomes compared to placebo based on Cox regression analysis (HR 0.27, p Conclusion Post-hoc analyses of efficacy outcomes in MISSION suggest that advanced NSCLC patients with EGFR mutations may derive a survival benefit from receiving 3rd/4th line sorafenib. These results must be interpreted with caution due to the small, non-representative nature of the genetic biomarker subpopulation analyzed in this trial. Further prospective investigation may be warranted. Disclosure T.S.K. Mok: Honoraria: AstraZeneca, Roche, Eli Lilly, Merck Serono, Eisai, BMS, BeiGene, AVEO, Pfizer, Taiho, Boehringer Ingelheim, and GSK Biologicals Speaker: Astrazeneca, Roche, Eli Lilly, Boehringer Ingelheim, and Merck Serono Research funding: Astrazeneca. L. Paz-Ares: Dr. Paz-Ares has received honoraria from Bayer HealthCare Pharmaceuticals, Lilly, Roche and Pfizer. Y. Wu: Dr. Wu has received lecture fees from Roche, AstraZeneca, Eli Lilly, and Pfizer. V. Hirsh: Member of the steering committee for the MISSION trial. C. Lathia: Dr. Lathia is an employee of Bayer HealthCare. T.J. Ong: Dr. Ong is an employee of, and owns shares in, Bayer HealthCare. C. Pena: Dr. Pena is an employee of Bayer HealthCare. All other authors have declared no conflicts of interest.

Published
2012

29. 9155 Sunitinib combined with pemetrexed and cisplatin in patients with advanced solid malignancies: phase I dose escalation study

Author

Richard C. Chao, D. Soulières, R. C. Doebele, Normand Blais, Derek J. Jonker, L.Q. Chow, D. R. Camidge, S. G. Eckhardt, Aron Thall, and Ana Ruiz-Garcia

Subjects
Oncology, Cisplatin, Cancer Research, medicine.medical_specialty, business.industry, Sunitinib, Pemetrexed, Internal medicine, Dose escalation, Medicine, In patient, business, medicine.drug
Published
2009

30. 49 POSTER Analyses of pharmacodynamic (PD) assessments collected during expanded cohorts (EC) of a phase I trial with OSI-930, a multi-targeted oral tyrosine kinase inhibitor (TKI)

Author

R. Gedrich, Michael Germuska, Hendrik Tobias Arkenau, George D. Demetri, D. R. Camidge, Michelle Scurr, N. J. Serkova, Suzanne George, Jennifer L. Spratlin, and K. Brock

Subjects
Cancer Research, Oncology, business.industry, medicine.drug_class, Pharmacodynamics, Medicine, Pharmacology, business, Tyrosine-kinase inhibitor
Published
2008

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