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1. Figure S2 from Phase II Single-arm Study of Durvalumab and Tremelimumab with Concurrent Radiotherapy in Patients with Mismatch Repair–proficient Metastatic Colorectal Cancer

Author

Leonard B. Saltz, Christopher H. Crane, Nancy Kemeny, Yoshiya Yamada, Stephen Solomon, Joseph Erinjeri, Marinela Capanu, Joanne F. Chou, Krishna Juluru, Travis J. Hollmann, Efsevia Vakiani, Taha Merghoub, Phillip Wong, Pallavi Vedantam, Aliya Holland, Matthew J. Adamow, Martinique Ogle, Mark L. Solter, Pamela Vaiskauskas, Kathleen C. Mcauliffe, Ghassan K. Abou-Alfa, David Faleck, Louise C. Connell, Rona Yaeger, Karuna Ganesh, Anna M. Varghese, Zsofia K. Stadler, Paul B. Romesser, Martin R. Weiser, T. Jonathan Yang, John Cuaron, Diane Reidy-Lagunes, Danny N. Khalil, Andreas Rimner, Abraham J. Wu, Geoffrey Ku, Andrea Cercek, and Neil H. Segal

Abstract

Flow dot plots

Published
2023
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2. Data from Phase II Single-arm Study of Durvalumab and Tremelimumab with Concurrent Radiotherapy in Patients with Mismatch Repair–proficient Metastatic Colorectal Cancer

Author

Leonard B. Saltz, Christopher H. Crane, Nancy Kemeny, Yoshiya Yamada, Stephen Solomon, Joseph Erinjeri, Marinela Capanu, Joanne F. Chou, Krishna Juluru, Travis J. Hollmann, Efsevia Vakiani, Taha Merghoub, Phillip Wong, Pallavi Vedantam, Aliya Holland, Matthew J. Adamow, Martinique Ogle, Mark L. Solter, Pamela Vaiskauskas, Kathleen C. Mcauliffe, Ghassan K. Abou-Alfa, David Faleck, Louise C. Connell, Rona Yaeger, Karuna Ganesh, Anna M. Varghese, Zsofia K. Stadler, Paul B. Romesser, Martin R. Weiser, T. Jonathan Yang, John Cuaron, Diane Reidy-Lagunes, Danny N. Khalil, Andreas Rimner, Abraham J. Wu, Geoffrey Ku, Andrea Cercek, and Neil H. Segal

Abstract

Purpose:Immune checkpoint inhibition (ICI) alone is not active in mismatch repair–proficient (MMR-P) metastatic colorectal cancer (mCRC), nor does radiotherapy alone result in objective systemic benefit. However, combined radiotherapy plus ICI can induce systemic antitumor immunity in preclinical and clinical models.Patients and Methods:In this single-center, phase II study, patients with chemotherapy-refractory MMR-P mCRC received durvalumab 1,500 mg plus tremelimumab 75 mg every 4 weeks plus radiotherapy. The primary endpoint was objective response rate (ORR) in nonirradiated lesions. Treatment and efficacy were correlated with peripheral immune cell profiles.Results:We enrolled 24 patients, and report outcomes after a median follow-up of 21.8 (range: 15.9–26.3) months. The ORR was 8.3% (2 patients) [95% confidence interval (CI), 1.0–27.0]. The median progression-free survival was 1.8 (95% CI, 1.7–1.9) months, median overall survival was 11.4 (95% CI, 10.1–17.4) months. Twenty five percent of patients (n = 6) had treatment-related grade 3–4 adverse events. We observed increased circulating CD8+ T lymphocyte activation, differentiation, and proliferation in patients with objective response.Conclusions:This combination of radiotherapy plus ICI study did not meet the prespecified endpoint criteria to be considered worthwhile for further study. However, rare instances of systemic immune augmentation and regression in nonirradiated lesions were observed (an abscopal response). Combination durvalumab and tremelimumab plus radiotherapy is feasible in MMR-P mCRC with a manageable safety profile. Further studies of novel immunotherapy combinations, and identification of biomarkers predictive of abscopal response are warranted.

Published
2023
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3. Figure S1 from Phase II Single-arm Study of Durvalumab and Tremelimumab with Concurrent Radiotherapy in Patients with Mismatch Repair–proficient Metastatic Colorectal Cancer

Author

Leonard B. Saltz, Christopher H. Crane, Nancy Kemeny, Yoshiya Yamada, Stephen Solomon, Joseph Erinjeri, Marinela Capanu, Joanne F. Chou, Krishna Juluru, Travis J. Hollmann, Efsevia Vakiani, Taha Merghoub, Phillip Wong, Pallavi Vedantam, Aliya Holland, Matthew J. Adamow, Martinique Ogle, Mark L. Solter, Pamela Vaiskauskas, Kathleen C. Mcauliffe, Ghassan K. Abou-Alfa, David Faleck, Louise C. Connell, Rona Yaeger, Karuna Ganesh, Anna M. Varghese, Zsofia K. Stadler, Paul B. Romesser, Martin R. Weiser, T. Jonathan Yang, John Cuaron, Diane Reidy-Lagunes, Danny N. Khalil, Andreas Rimner, Abraham J. Wu, Geoffrey Ku, Andrea Cercek, and Neil H. Segal

Abstract

Study design

Published
2023
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4. Table S1 from Phase II Single-arm Study of Durvalumab and Tremelimumab with Concurrent Radiotherapy in Patients with Mismatch Repair–proficient Metastatic Colorectal Cancer

Author

Leonard B. Saltz, Christopher H. Crane, Nancy Kemeny, Yoshiya Yamada, Stephen Solomon, Joseph Erinjeri, Marinela Capanu, Joanne F. Chou, Krishna Juluru, Travis J. Hollmann, Efsevia Vakiani, Taha Merghoub, Phillip Wong, Pallavi Vedantam, Aliya Holland, Matthew J. Adamow, Martinique Ogle, Mark L. Solter, Pamela Vaiskauskas, Kathleen C. Mcauliffe, Ghassan K. Abou-Alfa, David Faleck, Louise C. Connell, Rona Yaeger, Karuna Ganesh, Anna M. Varghese, Zsofia K. Stadler, Paul B. Romesser, Martin R. Weiser, T. Jonathan Yang, John Cuaron, Diane Reidy-Lagunes, Danny N. Khalil, Andreas Rimner, Abraham J. Wu, Geoffrey Ku, Andrea Cercek, and Neil H. Segal

Abstract

Radiation treatment summary

Published
2023
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5. Table S3 from Phase II Single-arm Study of Durvalumab and Tremelimumab with Concurrent Radiotherapy in Patients with Mismatch Repair–proficient Metastatic Colorectal Cancer

Author

Leonard B. Saltz, Christopher H. Crane, Nancy Kemeny, Yoshiya Yamada, Stephen Solomon, Joseph Erinjeri, Marinela Capanu, Joanne F. Chou, Krishna Juluru, Travis J. Hollmann, Efsevia Vakiani, Taha Merghoub, Phillip Wong, Pallavi Vedantam, Aliya Holland, Matthew J. Adamow, Martinique Ogle, Mark L. Solter, Pamela Vaiskauskas, Kathleen C. Mcauliffe, Ghassan K. Abou-Alfa, David Faleck, Louise C. Connell, Rona Yaeger, Karuna Ganesh, Anna M. Varghese, Zsofia K. Stadler, Paul B. Romesser, Martin R. Weiser, T. Jonathan Yang, John Cuaron, Diane Reidy-Lagunes, Danny N. Khalil, Andreas Rimner, Abraham J. Wu, Geoffrey Ku, Andrea Cercek, and Neil H. Segal

Abstract

Gene mutations in responder patients

Published
2023
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6. Table S4 from Phase II Single-arm Study of Durvalumab and Tremelimumab with Concurrent Radiotherapy in Patients with Mismatch Repair–proficient Metastatic Colorectal Cancer

Author

Leonard B. Saltz, Christopher H. Crane, Nancy Kemeny, Yoshiya Yamada, Stephen Solomon, Joseph Erinjeri, Marinela Capanu, Joanne F. Chou, Krishna Juluru, Travis J. Hollmann, Efsevia Vakiani, Taha Merghoub, Phillip Wong, Pallavi Vedantam, Aliya Holland, Matthew J. Adamow, Martinique Ogle, Mark L. Solter, Pamela Vaiskauskas, Kathleen C. Mcauliffe, Ghassan K. Abou-Alfa, David Faleck, Louise C. Connell, Rona Yaeger, Karuna Ganesh, Anna M. Varghese, Zsofia K. Stadler, Paul B. Romesser, Martin R. Weiser, T. Jonathan Yang, John Cuaron, Diane Reidy-Lagunes, Danny N. Khalil, Andreas Rimner, Abraham J. Wu, Geoffrey Ku, Andrea Cercek, and Neil H. Segal

Abstract

Flow cytometry result summary

Published
2023
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7. Phase II Single Arm Study of Durvalumab and Tremelimumab with Concurrent Radiotherapy in Patients with Mismatch Repair Proficient Metastatic Colorectal Cancer

Author

Joanne F. Chou, Anna M. Varghese, Pallavi Vedantam, Andrea Cercek, Andreas Rimner, Karuna Ganesh, Travis J. Hollmann, Nancy E. Kemeny, Joseph P. Erinjeri, Yoshiya Yamada, Paul B. Romesser, Diane Reidy-Lagunes, Efsevia Vakiani, Aliya Holland, Neil H. Segal, T. Jonathan Yang, Geoffrey Y. Ku, Abraham J. Wu, Mark L. Solter, Martinique Ogle, Martin R. Weiser, Kathleen C. McAuliffe, Christopher H. Crane, Phillip Wong, Stephen B. Solomon, Danny N. Khalil, John J. Cuaron, Louise Catherine Connell, Marinela Capanu, Krishna Juluru, Taha Merghoub, Leonard B. Saltz, Zsofia K. Stadler, Rona Yaeger, Pamela Vaiskauskas, Ghassan K. Abou-Alfa, David Faleck, and Matthew Adamow

Subjects
0301 basic medicine, Oncology, Adult, Male, Cancer Research, medicine.medical_specialty, Durvalumab, Colorectal cancer, medicine.medical_treatment, Phases of clinical research, CD8-Positive T-Lymphocytes, Antibodies, Monoclonal, Humanized, DNA Mismatch Repair, Article, 03 medical and health sciences, 0302 clinical medicine, Median follow-up, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Clinical endpoint, Humans, Immune Checkpoint Inhibitors, Response Evaluation Criteria in Solid Tumors, Aged, business.industry, Antibodies, Monoclonal, Immunotherapy, Chemoradiotherapy, Middle Aged, medicine.disease, Progression-Free Survival, Radiation therapy, 030104 developmental biology, 030220 oncology & carcinogenesis, Feasibility Studies, Female, business, Colorectal Neoplasms, Tremelimumab, medicine.drug, Follow-Up Studies
Abstract

Purpose:Immune checkpoint inhibition (ICI) alone is not active in mismatch repair–proficient (MMR-P) metastatic colorectal cancer (mCRC), nor does radiotherapy alone result in objective systemic benefit. However, combined radiotherapy plus ICI can induce systemic antitumor immunity in preclinical and clinical models.Patients and Methods:In this single-center, phase II study, patients with chemotherapy-refractory MMR-P mCRC received durvalumab 1,500 mg plus tremelimumab 75 mg every 4 weeks plus radiotherapy. The primary endpoint was objective response rate (ORR) in nonirradiated lesions. Treatment and efficacy were correlated with peripheral immune cell profiles.Results:We enrolled 24 patients, and report outcomes after a median follow-up of 21.8 (range: 15.9–26.3) months. The ORR was 8.3% (2 patients) [95% confidence interval (CI), 1.0–27.0]. The median progression-free survival was 1.8 (95% CI, 1.7–1.9) months, median overall survival was 11.4 (95% CI, 10.1–17.4) months. Twenty five percent of patients (n = 6) had treatment-related grade 3–4 adverse events. We observed increased circulating CD8+ T lymphocyte activation, differentiation, and proliferation in patients with objective response.Conclusions:This combination of radiotherapy plus ICI study did not meet the prespecified endpoint criteria to be considered worthwhile for further study. However, rare instances of systemic immune augmentation and regression in nonirradiated lesions were observed (an abscopal response). Combination durvalumab and tremelimumab plus radiotherapy is feasible in MMR-P mCRC with a manageable safety profile. Further studies of novel immunotherapy combinations, and identification of biomarkers predictive of abscopal response are warranted.

Published
2021

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