Keytruda in combination with Lynparza failed to show PFS and OS improvement in patients with metastatic NSCLC
Merck provided an update regarding the Phase 3 KEYLYNK-006 study, which is examining the efficacy of Keytruda (known as pembrolizumab), Merck's anti-PD-1 therapy, in combination with Lynparza(referred to as olaparib) for the treatment of specific patients afflicted with metastatic nonsquamous non-small cell lung cancer (NSCLC).
The findings from the KEYLYNK-006 trial indicate that the combination of Keytruda with chemotherapy followed by Keytruda alongside maintenance Lynparzadid not achieve the primary goals of overall survival (OS) and progression-free survival (PFS) for individuals receiving first-line treatment for metastatic nonsquamous NSCLC.
Throughout the trial, the combination treatment involving Keytruda and Lynparzafailed to meet the predetermined statistical benchmarks for OS or PFS when compared to the regimen of Keytruda paired with chemotherapy, followed by Keytruda accompanied by maintenance chemotherapy. The safety profiles observed during this trial align with previously documented data from separate studies on each therapy. A comprehensive analysis of the trial data is ongoing, with Merck intending to collaborate with investigators to disseminate the findings within the scientific community.
KEYLYNK-006, characterized as a randomized, open-label, two-phase Phase 3 trial, aimed to assess the efficacy of Keytruda in combination with chemotherapy followed by either Lynparzamaintenance or maintenance chemotherapy for patients diagnosed with metastatic nonsquamous NSCLC lacking specific genomic tumour aberrations. The study's primary endpoints encompassed PFS as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) through blinded independent central review (BICR) and OS. Secondary endpoints included evaluations of safety and health-related quality of life. The trial initially enrolled approximately 1,005 patients in its Induction Phase and subsequently randomized 672 patients exhibiting either a complete or partial response or maintaining stable disease. During the Induction Phase, participants received Keytruda in combination with pemetrexed plus either carboplatin or cisplatin every three weeks for four cycles. In the Maintenance Phase, patients with sustained complete or partial responses or stable disease post-induction therapy were randomized to receive either Keytruda plus maintenance Lynparzaor Keytruda plus maintenance pemetrexed until the progression of the disease, a decision by the physician, or intolerable toxicity.
Lung cancer stands as the leading cause of cancer-related mortality worldwide. In 2022 alone, the global incidence of new cases amounted to approximately 2.4 million, resulting in 1.8 million deaths. Non-small cell lung cancer constitutes the majority, approximately 80%, of lung cancer cases. As of 2024, the overall five-year survival rate for lung cancer patients in the United States is 25%.