8/18/2023 0 Comments Pcr complete responseThese results are being presented today during a clinical science symposium, The Promise of Neoadjuvant Immunotherapy Across Solid Tumors, at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (abstract #LBA100) and are also being simultaneously published in the New England Journal of Medicine. The safety profile of the KEYTRUDA regimen was consistent with the safety profile in earlier stages and metastatic NSCLC, with no new safety concerns identified. A favorable trend in OS was observed for the KEYTRUDA regimen versus pre-operative chemotherapy (HR 0.73 p=0.02124) with only 177 events, these OS data are not mature and did not reach statistical significance at the time of this interim analysis. The trial is continuing to allow for additional follow-up of overall survival (OS), the other dual primary endpoint. For patients who received the KEYTRUDA-based regimen, median EFS was not reached (95% CI, 34.1-NR) versus 17 months (95% CI, 14.3-22) for patients who received chemotherapy alone. After a median follow-up of 25.2 months, neoadjuvant KEYTRUDA plus chemotherapy followed by resection and adjuvant single-agent KEYTRUDA significantly improved EFS, reducing the risk of disease recurrence, progression or death by 42% (HR=0.58 p<0.00001) for patients with resectable stage II, IIIA or IIIB NSCLC versus neoadjuvant placebo plus chemotherapy followed by adjuvant placebo. Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive results from the pivotal Phase 3 KEYNOTE-671 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as a perioperative treatment regimen, which includes treatment before surgery (neoadjuvant) and after surgery (adjuvant), for patients with resectable stage II, IIIA or IIIB non-small cell lung cancer (NSCLC). KEYNOTE-671 is the eighth positive pivotal study evaluating a KEYTRUDA-based regimen in earlier stages of cancer and the seventh positive pivotal study in lung cancer The group demonstrated that pCR defined as no residual invasive cancer in the breast and axillary nodes with presence or absence of in situ cancer (ypT0/is ypN0 or ypT0 ypN0) provided a better association with improved outcomes compared to eradication of invasive tumor from the breast alone (ypT0/is).Įven though pCR was not validated as a surrogate endpoint for long-term outcomes, the promising data regarding the strong association of pCR with substantially improved outcomes in individual patients with more aggressive subtypes of breast cancer supported the opening of an accelerated approval pathway for patients with high-risk, early-stage breast cancer.Based on a subgroup analysis, improvement in event-free survival (EFS) with the KEYTRUDA-based regimen was consistent across all PD-L1 expression subgroups, histology and stageĮxploratory subgroup analysis showed a reduction in EFS events with the KEYTRUDA perioperative regimen for patients with or without pathological complete response (pCR) compared with the chemotherapy-placebo regimen The US Food and Drug Administration established the Collaborative Trials in Neoadjuvant Breast Cancer group to evaluate the potential use of pCR as a regulatory endpoint. Varying definitions of pCR across clinical trials conducted in heterogeneous patient populations make understanding the association of pCR with long-term outcomes challenging. We review the clinical trials that have contributed to our understanding of the association between pCR and long-term outcomes, describe the various definitions of pCR, describe patient populations in which pCR may predict long-term benefit, and discuss the implications of pCR on drug development and accelerated approval for neoadjuvant treatment of breast cancer. There has been recent interest in using pathological complete response (pCR) as a potential surrogate endpoint for long-term outcomes in the neoadjuvant treatment of high-risk, early-stage breast cancer.
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