Merck Increases Lead In Lung Cancer With Approval For Keytruda/Chemo Combo; Share Price Surges
Written by John Carroll (ENDpts.com)
Merck & Co., Inc. (MRK) has been given FDA approval to start marketing a combination of its PD-1 drug Keytruda with chemotherapy as a first-line therapy for the treatment of non-small cell lung cancer advancing its leadership in treating that crucial market. Its shares immediately popped, surging 4% on the news in after-market trading, while rival Bristol-Myers Squibb (BMY) took another beating, sliding 2%.
Merck built its bid for an accelerated approval around Phase II data demonstrating that the chemo/checkpoint combo spurred a much higher concentration of overall responses for NSCLC than chemo alone — 55% vs. 29%, P = 0.0016. High PD-L1 expressers did even better, though the approval comes through for all patients regardless of biomarker status. That all translates into billions in revenue, with consensus sales forecast of $3.6 billion for 2017 revenue - and climbing...
Merck’s R&D team under Roger Perlmutter has won at least a temporary advantage in a blockbuster arena and analysts have been acutely aware of the revenue potential — though nothing is written in stone in this fast-changing cancer field...
Seamus Fernandez at Leerink noted just how significant this decision was for Merck, writing:
We continue to look towards the 5/10/17 PDUFA data for the Keytruda (pembrolizumab; anti-PD-1) + chemo combo in first-line (1L) non-small cell lung cancer (NSCLC) for a meaningful acceleration in the drug’s US sales.
Although this will help to drive top- and bottom-line growth towards the end of the year and into 1H:18, the large number of IO+IO and IO+chemo trials reporting during that period could dramatically alter the 1L NSCLC landscape.
When it comes to checkpoints, with 5 approved and more piling in, every new goal is attracting a swarm of rivals.
Dr. Corey Langer, Director of Thoracic Oncology 7 Professor of Medicine at the Hospital of the University of Pennsylvania, said in a statement:
“This approval marks an important milestone in the treatment of lung cancer.
Now, pembrolizumab in combination with pemetrexed and carboplatin can be prescribed in the first-line setting for patients with metastatic nonsquamous non-small cell lung cancer, irrespective of PD-L1 expression.
Physicians should continue to use each patient’s individual characteristics – including biomarker status, histology, and other clinical factors – to determine the best treatment plan for each person.”
Today Merck winds up one big step forward in NSCLC. How long it keeps that lead, though, is anybody’s guess.
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