Merck gets first-line NSCLC guideline as Bristol denied

Merck building

The National Comprehensive Cancer Network (NCCN) has weighed in on the checkpoint inhibitor race to first-line treatment in non-small cell lung cancer (NSCLC). It gave Merck’s ($MRK) Keytruda a thumbs-up, but denied both Bristol-Myers Squibb's ($BMY) Opdivo. 

All three are FDA-approved to treat second-line NSCLC, with Tecentriq just gaining that distinction earlier this week. Keytruda had strong positive data in June in first-line NSCLC, but in August, Opdivo failed in a Phase III trial in the same indication.

NCCN is an alliance of 27 leading cancer centers. It offers treatment guidelines determined by a voting panel of physicians that are based on late-stage clinical data, which often run ahead of FDA decisions on approvals but guide physicians in determining off-label treatment.


Like this story? Subscribe to FierceBiotech!

Biopharma is a fast-growing world where big ideas come along every day. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go.

The NCCN vote was unanimously in favor for treatment of first-line NSCLC with Keytruda based on its Keynote-024 data, observed Wall Street analyst Timothy Anderson at Sanford Bernstein in an Oct. 18 note.

Merck filed in September with the approval of the anti-PD-1 drug in this indication. Keytruda is also currently under FDA review for a full approval of Keytruda in second-line NSCLC with a PDUFA date of Oct. 24.

Based on its showing in Checkmate-012, Opdivo was unanimously denied inclusion in the first-line NSCLC treatment guidelines. Anderson noted that investors are clinging to hope that an all-BMS combo of Opdivo and Yervoy will save the day for the pharma in a first-line indication, which is in Phase III clinical testing.

“Investor consensus has been (and remains) very positive on the prospects for this combination approach. While estimates have been reduced on Opdivo in recent weeks, a partial offset by some analysts has been to boost Yervoy sales,” said Anderson.

“The basis for investor excitement with BMY’s approach is primarily driven by preliminary findings from the Phase I Checkmate-012 study. Three sets of interim results have been presented over the last 12mo that have looked promising, and one BMY KOL recently suggested it could potentially be combined with results from another smaller trial (Checkmate-568) to form an early registration package, but it is not clear to us that this is realistic,” he concluded.

Roche's Tecentriq tried to squeak into second-line NSCLC guidelines as well based on Phase II data, but was also unanimously denied.

Suggested Articles

By employing heart rate signals, physical activity and sleep quality, common Fitbit trackers may be able to predict the spread of the flu.

Nanox has raised $26 million to help fuel the development and commercialization of its Star Trek-inspired digital X-ray bed.

Oncology is clearly a major medical and societal issue, but one that sees too much focus from biopharmas at the expense of other killers.