Keytruda-Lynparza combination misses survival targets in phase 3 lung cancer trial
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The combination of pembrolizumab and maintenance olaparib failed to significantly improve survival outcomes among adults with metastatic nonsquamous non-small cell lung cancer, according to the agent’s manufacturer.
The randomized phase 3 KEYLYNK-006 trial assessed the saftey and efficacy of pembrolizumab (Keytruda, Merck) —a PD-1 inhibitor — in combination with maintenance therapy using the PARP inhibitor olaparib (Lynparza, Merck) for the first-line treatment of adults with metastatic nonsquamous non-small cell lung cancer
Study participants (n = 1,005) had no epidermal growth factor receptor, anaplastic lymphoma kinase or proto-oncogene tyrosine-protein kinase genomic tumor aberrations. OS and PFS served as study’s dual primary endpoints, with secondary endpoints comprising safety and health-related quality-of-life assessments.
During the induction phase of the open-label trial, patients received 200 mg IV pembrolizumab in combination with pemetrexed plus investigator’s choice of platinum chemotherapy. During the maintenance phase, patients with a complete or partial response or with stable disease following four cycles of induction therapy received 200 mg IV pembrolizumab every 3 weeks for up to 31 cycles plus either 300 mg oral olaparib twice daily or 500 mg/m2 maintenance pemetrexed every 3 weeks until disease progression, physician decision or intolerable toxicity.
The investigative combination therapy did not meet the prespecified statistical criteria for improvement in OS or PFS compared with pembrolizumab in combination with chemotherapy followed by pembrolizumab plus maintenance chemotherapy.
However, the safety profiles of the two agents appeared consistent with previously reported data.
A full evaluation of study results is ongoing, and Merck said it “will work with investigators to share the results with the scientific community,” according to the release.
“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,” Gregory Lubiniecki, MD, vice president of global clinical development at Merck Research Laboratories, said in a press release. “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.”
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