Replacing the chemotherapy pemetrexed with Lynparza during the maintenance treatment of newly diagnosed metastatic nonsquamous NSCLC didn’t improve patients’ life expectancy, nor was the approach able to significantly delay progression or death, Merck said Thursday.
The R&D setback came from the phase 3 KEYLYNK-006 trial. The experimental regimen uses Keytruda in combination with a chemotherapy doublet as induction treatment, followed by Keytruda plus Lynparza, and then Lynparza alone until progression. Patients in the control group received pemetrexed instead of Lynparza.
In NSCLC, the nonsquamous histology of tumors creates a difficult situation for Lynparza to make a difference. After all, Keytruda and chemo already set a high efficacy bar, showing a 51% reduction in the risk of death versus chemo alone.
Given the several recent trial flops, KEYLYNK-012 now looks like an uncertain bet. Besides the two Keytruda-Lynparza disappointments in the metastatic setting, AZ in November found that concurrent administration of Imfinzi and chemoradiotherapy missed the mark when compared with the traditional post-chemoradiation Imfinzi regimen in stage 3 NSCLC, according to the phase 3 PACIFIC-2 trial. Not only did the concurrent regimen fail to improve progression-free survival, but it also showed an increased rate of infection.
Still, Merck remains committed to exploring Keytruda-based combinations in lung cancer, Gregory Lubiniecki, a VP of global clinical development at Merck Research Laboratories, said in a statement Thursday.
Meanwhile, antibody-drug conjugates have emerged as promising combo pairs with anti-PD-1cancer immunotherapies. ADCs’ tumor-targeted delivery of chemotherapy makes them ideal candidates to replace conventional systemic chemotherapy with lower toxicity and hopefully better efficacy.
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