MSD looks to jump the gun with combination immunotherapy application

pharmafile | January 11, 2017 | News story | Research and Development, Sales and Marketing AstraZeneca, BMS, MSD, Roche, immunotherapy, keytruda 

MSD, known as Merck in North America, has launched a bold move by filing Keytruda, and being accepted, for Priority Review as combination treatment alongside chemotherapy. The move has taken the industry by surprise, as MSD had not been expected to apply so quickly and, if approved, would have a head start on competitors also working on their own combination therapies.

It is the first time MSD has applied for approval of Keytruda alongside another treatment. The FDA will reach its decision by 10 May. The application comes on the back of Phase 2 trial data, which displayed positive results. However, MSD were expected to wait upon further Phase 3 trial data to strengthen its case in front of the FDA. This process would have likely lead to filing to the FDA late in this year.

The surprise move aims to jump the gun on MSD’s competitors who are working to have their own combination therapies reach the market. AstraZeneca and Bristol-Myers Squibb are looking to reach market with a dual-immunotherapy treatment; whilst Roche are also looking to add chemotherapy to Tecentriq.

The potential gains for MSD, if the combination treatment is approved, are significant, with lung cancer one of the biggest threats to public health and with plenty of the market still up for grabs. It would more than likely face immediate competition once approved but the head start may be enough to provide important in-roads into the market before its competitors caught up.

“Through our monotherapy and combination studies, we are working to find new approaches to help a broad range of patients with lung cancer,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “Keytruda in combination with chemotherapy has shown promise versus chemotherapy alone in the first-line treatment of non-squamous metastatic non-small cell lung cancer, regardless of PD-L1 levels. If approved, this could be the first regimen combining chemotherapy with an immuno-oncology agent for patients with advanced non-small cell lung cancer.”

Ben Hargreaves

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