This week's pharma briefing: cancer drug scores a win, Merck targets an EBV vaccine, and an Alzheimer's drug gets priority review

Republished with permission from Pharmascan

Trastuzumab deruxtecan, the cancer drug developed by AstraZeneca (AZ) and Daiichi Sankyo, delivered positive results: the Phase II DESTINY-PanTumor02 trial met both its primary and secondary endpoints.

The trial was designed to evaluate the drug's efficacy and safety in patients with HER2-expressing, locally advanced or metastatic solid tumors who had received multiple prior lines of therapy. The primary endpoint was objective response rate (ORR), with duration of response (DoR) as the secondary endpoint.

DESTINY-PanTumor02 enrolled 268 participants, spanning biliary tract, bladder, cervical, endometrial, ovarian, pancreatic and rare cancers. Observers believe the results could help the drug win US FDA approval for previously treated, HER2-expressing patients — regardless of tumor location.

Merck (known as MSD outside the US and Canada) announced a partnership with Opko　Health, signing a contract worth up to US$922.5 million targeting the Epstein-Barr virus vaccine candidate MDX-2201. The FDA has yet to approve any EBV vaccine.

The two companies will jointly develop the candidate until the US FDA formally clears it to begin clinical trials, at which point Merck will take over subsequent clinical development and regulatory strategy. Under the contract, Opko will receive US$50 million upfront, with the potential to earn US$872.5 million in future milestone payments.

Merck is building out its vaccine portfolio aggressively: it is currently partnering with Moderna on a cancer vaccine (mRNA-4157/V940), whose combination with the cancer immunotherapy pembrolizumab recently received US FDA breakthrough therapy designation.

Biogen and Eisai's Alzheimer's drug lecanemab received priority review for its supplemental biologics license application. Lecanemab had just cleared the FDA's accelerated approval pathway in January.

Despite high expectations for lecanemab's commercial prospects, the FDA's final decision will still take into account the verdict of an advisory committee of experts, and no meeting date has yet been set.

Under the Prescription Drug User Fee Act (PDUFA), the FDA must announce its decision by July 6, 2023. If all goes well, lecanemab will convert its current accelerated approval into traditional full approval.

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