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FDA Approval Summary: Atezolizumab Plus Paclitaxel Protein-bound for the Treatment of Patients with Advanced or Metastatic TNBC Whose Tumors Express PD-L1
- Source :
- Clinical Cancer Research. 26:2284-2289
- Publication Year :
- 2020
- Publisher :
- American Association for Cancer Research (AACR), 2020.
-
Abstract
- On March 8, 2019, the FDA granted accelerated approval to atezolizumab in combination with paclitaxel protein-bound for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 [PD-L1 stained tumor-infiltrating immune cells (IC) of any intensity covering ≥1% of the tumor area], as determined by an FDA-approved test. Approval was based on data from IMpassion130, which randomized patients to receive atezolizumab or placebo in combination with paclitaxel protein-bound. Investigator-assessed progression-free survival (PFS) in the intent-to-treat (ITT) and PD-L1–positive populations were coprimary endpoints. After 13-month median follow-up, the estimated median PFS in the PD-L1–positive population was 7.4 months in the atezolizumab arm and 4.8 months in the placebo arm [HR = 0.60; 95% confidence interval (CI), 0.48–0.77]. Overall survival (OS) results were immature with 43% deaths in the ITT population, representing 59% of the OS events required to perform the final OS analysis. Adverse reactions occurring in ≥20% of patients receiving atezolizumab with paclitaxel protein-bound were alopecia, peripheral neuropathies, fatigue, nausea, diarrhea, anemia, constipation, cough, headache, neutropenia, vomiting, and decreased appetite. Accelerated approval was appropriate taking into account the unmet medical need along with the immaturity of the OS results and potential for PFS in the PD-L1–expressing population to predict clinical benefit.
- Subjects :
- Adult
Male
0301 basic medicine
Oncology
Cancer Research
medicine.medical_specialty
Adolescent
Paclitaxel
Nausea
Population
Triple Negative Breast Neoplasms
Neutropenia
Antibodies, Monoclonal, Humanized
Placebo
B7-H1 Antigen
Young Adult
03 medical and health sciences
0302 clinical medicine
Breast cancer
Double-Blind Method
Atezolizumab
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
Neoplasm Metastasis
education
Drug Approval
Survival rate
Aged
education.field_of_study
United States Food and Drug Administration
business.industry
Middle Aged
Prognosis
medicine.disease
United States
Survival Rate
030104 developmental biology
030220 oncology & carcinogenesis
Vomiting
Female
medicine.symptom
business
Follow-Up Studies
Subjects
Details
- ISSN :
- 15573265 and 10780432
- Volume :
- 26
- Database :
- OpenAIRE
- Journal :
- Clinical Cancer Research
- Accession number :
- edsair.doi.dedup.....2a3eaf14e326593bcc499803682b40d1