Doctors hail Moderna-Merck vaccine data despite selloff

Oncologists are calling the late-stage results for Moderna and Merck's personalized melanoma vaccine a meaningful step forward, even though investors sold off the stock. Partial data from the Phase 3 trial leaked online on Thursday, Oct. 22, two days before the planned presentation at the European Society for Medical Oncology (ESMO) congress in Madrid. Moderna shares fell as much as 25% that day before recovering some of the loss, CNBC reported. Bloomberg described the reaction as a rare split between doctors, who celebrated the result, and Wall Street.cnbc.com+1

A Leak and Early Release

An oncology news site posted the embargoed figures and quickly took them down. ESMO then released the abstract and lifted the embargo on the full dataset, the Boston Globe reported. The trial enrolled 1,137 patients with high-risk melanoma whose tumors had been surgically removed. Adding the vaccine, intismeran autogene, to Merck's Keytruda cut the risk of recurrence or death by 42% compared with Keytruda alone, a hazard ratio of 0.58. It also cut the risk of distant metastasis or death by 38%. After two years, 82% of patients on the combination were alive without recurrence, compared with 70% on Keytruda alone.bostonglobe.com

Investors had hoped the trial would match the roughly 49% risk reduction seen in the earlier Phase 2 study. RBC Capital Markets analyst Trung Huynh called the results clinically meaningful and likely approvable, but said the main result landed at the low end of expectations. BMO Capital Markets said the data were "not enough to drive confidence amidst elevated expectations," BioSpace reported. Moderna closed down 17.6% on Thursday. Its stock had risen nearly 600% this year on optimism about the vaccine.biospace.com+1

Why Doctors Are Encouraged

Six melanoma specialists told CNBC the combination could become a standard of care for patients who have surgery first. "This has the potential to be a major breakthrough in melanoma treatment," said Dr. Sekwon Jang of Inova Schar Cancer. In the first six months, the combination performed about the same as Keytruda alone. After six months, it cut the risk of recurrence or death by 58%. Dr. George Ansstas of Washington University said the delay may reflect the roughly six weeks needed to make each patient's vaccine. He also noted that the Phase 3 trial included some lower-risk patients than Phase 2 did.cnbc.com

Open Questions

Overall survival data are not yet mature. Questions also remain about how long the benefit lasts and whether the companies can make an individualized therapy at scale. "You can't just stockpile a million vaccines," said Dr. Adil Daud of UCSF, the trial's lead investigator. Moderna CEO Stéphane Bancel said the company is finishing its regulatory filing and aims for full approval next year. The detailed results will be presented at ESMO on Saturday, Oct. 24.finance.yahoo.com+1