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Merck Faces Setback with Keytruda Combination Therapy Merck Faces Setback with Keytruda Combination Therapy

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    Merck Faces Setback with Keytruda Combination Therapy

Merck & Co Inc (NYSE: MRK) released topline data from the Phase 3 KEYLYNK-006 trial evaluating Keytruda (pembrolizumab) in combination with maintenance Lynparza (olaparib) for certain patients with metastatic nonsquamous non-small cell lung cancer.

The trial did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment.

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).

A full evaluation of the data from this study is ongoing.

In December, Merck announced to stop the Phase 3 KEYLYNK-008 of Keytruda in combination with maintenance Lynparza in metastatic squamous non-small cell lung cancer based on an independent Data Monitoring Committee recommendation.

At the interim analysis, Keytruda in combination with chemotherapy followed by Keytruda plus Lynparza did not demonstrate an improvement in OS compared to Keytruda in combination with chemotherapy followed by Keytruda plus placebo.

The study’s other dual primary endpoint, PFS, was not statistically significant, but there was a numerical improvement compared to the control arm.

Two years ago, Merck stopped the Phase 3 KEYLYNK-010 trial investigating Keytruda combined with Lynparza for metastatic castration-resistant prostate cancer (mCRPC).

At the interim analysis, the combination of Keytruda and Lynparza did not demonstrate a benefit in overall survival (OS) compared to the control arm of either abiraterone acetate or enzalutamide.

In 2017, AstraZeneca Plc (NASDAQ: AZN) and Merck collaborated to co-develop and co-commercialize Lynparza and Koselugo (selumetinib) for multiple cancer types.

Price Action: MRK shares are up 0.11% at $123.99 on the last check Thursday.