Merck’s lung cancer drug performs well in Phase II trial

The randomized Phase II trial for the Stimuvax MUC-1 vaccine was conducted in non-small cell lung cancer (NSCLC) patients.

Merck says the results suggest that Stimuvax combined with best supportive care (BSC) may provide survival benefits to patients with unresectable stage IIIB NSCLC who had either responded or had stable disease after initial radio-chemotherapy compared to patients receiving BSC alone.

The updated survival results show that more than twice as many patients were still alive at three years in the Stimuvax arm compared to BSC alone (49%/17 patients vs 27%/8 patients respectively), representing a 45% reduction in mortality.

Patients with stage IIIB locoregional disease who received Stimuvax in this trial also experienced a 17.3 month difference in median survival compared to patients receiving BSC alone (30.6 months vs 13.3 months respectively).

Patients reported mild to moderate side effects including flu-like symptoms, gastro-intestinal disturbances and mild injection-site reactions.

“The updated survival data are encouraging and support the need for further investigation via the ongoing Phase III trial of Stimuvax as a maintenance therapy for patients with advanced lung cancer,” commented Dr Charles Butts, lead investigator of the Phase II study.

Based on these Phase II results, Stimuvax has entered its Phase III development and the START (stimulating targeted antigenic responses to NSCLC) trial is currently open for enrollment.