Alliance Foundation Trial 09: A Randomized, Multicenter, Phase 2 Trial Evaluating Two Sequences of Pembrolizumab and Standard Platinum-Based Chemotherapy in Patients With Metastatic NSCLC
Year: 2021
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Introduction The sequence of chemotherapy and pembrolizumab may affect antitumor immune response and efficacy of immunotherapy. Methods This multicenter, randomized, phase 2 trial was designed to evaluate the efficacy of two sequences of chemotherapy and pembrolizumab in patients with stage 4 NSCLC. Both arms were considered investigational, and the study used a "pick a winner" design. The primary end point was objective response rate by independent radiologic review after eight cycles (24 wk). Patients were randomized 1:1 to arm A (chemotherapy for four cycles followed by pembrolizumab for four cycles) or arm B (pembrolizumab for four cycles followed by chemotherapy for four cycles). Patients in both arms without disease progression after the initial eight cycles continued pembrolizumab until disease progression, unacceptable toxicity, or a maximum of 2 years. Results From March 2016 to July 2018, a total of 90 eligible patients were randomized (43 patients to arm A and 47 patients to arm B). The objective response rate at 24 weeks in arms A and B was 39.5 % (95 % confidence interval [CI]: 24.9%–54.1 %) and 40.4 % (95 % CI: 26.4%–54.5 %), respectively ( p = 0.93). The progression-free survival in arms A and B was as follows: hazard ratio of B versus A equals to 1.06, 95 % CI: 0.68–1.66, p value equals to 0.84, and median progression-free survival of 5.8 months and 4 months, respectively. The overall survival was as follows: hazard ratio of B versus A equals to 1.04, 95 % CI: 0.63–1.74, p value equals to 0.85, and median overall survival of 15.5 months and 14 months, respectively. Conclusions Additional evaluation of either sequence in a phase 3 trial is not warranted.
Institutions: University of Chicago, Duke University, Duke Cancer Institute, The Ohio State University Wexner Medical Center, The Ohio State University, Washington University in St. Louis, HealthPartners, SUNY Upstate Medical University, Northwestern University, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Missouri Baptist Medical Center, Dartmouth–Hitchcock Medical Center, Dartmouth Cancer Center, University of Chicago Medical Center
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,000
Funders: Amgen, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, AstraZeneca, GlaxoSmithKline, Merck, Novartis, Gilead Sciences, Celgene, AbbVie, Takeda Pharmaceuticals U.S.A., CSL Behring, Regeneron Pharmaceuticals, G1 Therapeutics, Sirtex Medical, Genentech, EMD Serono, National Cancer Institute, Janssen Biotech
OpenAlex ID: W3179566064