Merck (MSD) has announced plans to discontinue the Phase III KEYLYNK-008 clinical trial of Keytruda plus Lynparza regimen to treat metastatic squamous non-small cell lung cancer (NSCLC), due to futility.

The latest move comes after the trial’s independent Data Monitoring Committee (DMC) recommended stopping the trial.

DMC analysed the findings from the trial’s planned third interim analysis. 

The data showed that Keytruda plus chemotherapy followed by Keytruda along with Lynparza failed to show an improvement in overall survival (OS) versus Keytruda plus chemotherapy followed by Keytruda plus placebo.

The dual primary endpoints of the trial were OS and progression-free survival (PFS).

In a second interim analysis, Keytruda plus Lynparza regimen did not offer statistically significant PFS but demonstrated numerical improvement versus the control arm. 

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By GlobalData

The safety profile reported in the KEYLYNK-008 trial was in line with that observed in prior studies of individual treatments without any new safety signals detected. 

The investigators will be notified of the latest DMC recommendation to discontinue the trial.

Keytruda is an anti-programmed death receptor-1 therapy developed by MSD while Lynparza is a PARP inhibitor.

Merck has a comprehensive clinical development programme in lung cancer and is progressing with several registration-enabling trials for treating earlier disease stages. 

KEYLYNK-006, KEYLYNK-012, KEYVIBE-003, KEYVIBE-006 and KEYVIBE-007 are the company’s major trials analysing Keytruda-based regimens to treat NSCLC.

Merck Research Laboratories global clinical development late-stage oncology head and senior vice-president Dr Marjorie Green said: “While there have been significant scientific advancements in lung cancer research in recent years, unmet needs remain for patients with advanced non-small cell lung cancer.

“We sincerely thank the patients and investigators for their participation in this study, and we will continue to advance our clinical development program to evaluate Keytruda-based combinations and novel candidates for patients with lung cancer.”

The latest development comes after MSD collaborated with HiberCell to carry out a Phase Ib clinical trial of Welireg plus HC-7366 in patients with clear cell renal cell carcinoma.