On March 21, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the Phase 3 KEYLYNK-006 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with maintenance LYNPARZA, a PARP inhibitor, did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment of certain patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) (Press release, Merck & Co, MAR 21, 2024, View Source [SID1234641342]).
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In the KEYLYNK-006 trial, KEYTRUDA in combination with chemotherapy followed by KEYTRUDA plus maintenance LYNPARZA did not meet the study’s pre-specified statistical criteria for OS or PFS compared to KEYTRUDA in combination with chemotherapy (pemetrexed plus carboplatin or cisplatin) followed by KEYTRUDA plus maintenance chemotherapy (pemetrexed). The safety profiles of KEYTRUDA and LYNPARZA in this trial were consistent with those observed in previously reported studies for the individual therapies. A full evaluation of the data from this study is ongoing. Merck will work with investigators to share the results with the scientific community.
"As lung cancer continues to be the leading cause of cancer death worldwide, we are committed to exploring KEYTRUDA-based combinations and novel candidates that may further help improve patient outcomes," said Dr. Gregory Lubiniecki, vice president, global clinical development, Merck Research Laboratories. "These results are an important reminder of how challenging it may be to treat these patients with metastatic nonsquamous non-small cell lung cancer. We sincerely thank the patients and investigators for their important contributions to this study."
About KEYLYNK-006
KEYLYNK-006 is a randomized, open-label, two-phase Phase 3 trial (ClinicalTrials.gov, NCT03976323) evaluating KEYTRUDA in combination with chemotherapy (pemetrexed plus carboplatin or cisplatin) followed by either KEYTRUDA plus maintenance LYNPARZA or KEYTRUDA plus maintenance chemotherapy (pemetrexed) for the first-line treatment of patients with metastatic nonsquamous NSCLC with no epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) or proto-oncogene tyrosine-protein kinase (ROS1) genomic tumor aberrations. The dual primary endpoints are PFS per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR) and OS. The secondary endpoints include safety and health-related quality of life assessments. The trial enrolled an estimated 1,005 patients in the Induction Phase and randomized 672 patients with a complete or partial response or with stable disease. In the Induction Phase, patients received KEYTRUDA (200 mg intravenously [IV]) in combination with pemetrexed plus investigator’s choice of platinum chemotherapy, consisting of either carboplatin Area Under the Curve (AUC) (5 mg/mL/min IV) or cisplatin (75 mg/m2 IV) every three weeks (Q3W) for four cycles. In the Maintenance Phase, patients with a complete or partial response or with stable disease after completing four cycles of induction therapy were randomized to receive either KEYTRUDA (200 mg IV Q3W for up to 31 cycles) plus maintenance LYNPARZA (300 mg orally twice daily) or KEYTRUDA (200 mg IV Q3W for up to 31 cycles) plus maintenance pemetrexed (500 mg/m2 IV Q3W) until progressive disease, physician decision or intolerable toxicity.
About lung cancer
Lung cancer is the leading cause of cancer death worldwide. In 2022 alone, there were approximately 2.4 million new cases and 1.8 million deaths from lung cancer globally. Non-small cell lung cancer is the most common type of lung cancer, accounting for about 80% of all cases. In 2024, the overall five-year survival rate for patients diagnosed with lung cancer is 25% in the United States. Improved survival rates are due, in part, to earlier detection and screening, reduction in smoking, advances in diagnostic and surgical procedures, as well as the introduction of new therapies. Early detection and screening remain an important unmet need, as 44% of lung cancer cases are not found until they are advanced.