Leapfrogging rivals, Roche’s Tecentriq plus chemo nabs PFS endpoint in frontline lung cancer segment

Roche has nabbed the first shot at a frontline indication for a significant share of the all-important lung cancer market with today’s news that their checkpoint Tecentriq hit the primary endpoint on progression-free survival for squamous non-small cell lung cancer. Some analysts say that indication could be worth more than a billion dollars a year in added revenue.

Sandra Horning

Researchers combined Tecentriq with Abraxane-based chemo and compared it to chemo in first line patients with advanced NSCLC. At an interim point the combination beat out chemo on PFS with a statistically significant outcome but had yet to show an overall survival benefit. Investigators will now keep on tracking results to see how OS measures out.

There were no data points in Roche’s statement. The positive PFS results, though, give Roche a chance to march ahead of a bevy of competition from Merck, Bristol-Myers Squibb and others in a key cancer market where the competition has been intense. And they’ll likely get a helping hand from the FDA, which has been eager to stamp these checkpoints from the major players with accelerated approvals.

Jefferies rushed out a note early Tuesday highlighting some blockbuster potential for Roche, which has been scrambling to catch up with the leaders in checkpoint inhibition and looked to gain a first-to-market advantage here. They note:

IMpower131 is an important study for Roche. Squamous cell NSCLC, which accounts for c.25%-30% of NSCLC, is a more complicated disease than non-squamous NSCLC and there are fewer treatment options. Roche has previously noted that it could be first to market in the 1L squamous NSCLC setting if IMpower131 produced a superior result. We currently model $1.1bn of peak sales for Tecentriq in this 1L squamous setting and have previously highlighted that a positive result from the trial could see 1%-3% upside to EPS and valuation.

Merck and Bristol-Myers have taken the lead role in the overall lung cancer market, but none of the competition is ceding control. IMpower131 is one of five Phase III readouts that Roche has for lung cancer this year. And three more are in the clinic. During their Q4 review last month, Roche pharma chief Daniel O’Day sounded bullish on Roche’s chances of carving out a big piece of the market for itself.

Their ongoing studies, he said, “will dimensionalize the first-line lung cancer space in 2018.”

“I’m convinced there will be multiple options for different patient types in this setting which accounts for around 45% of the lung cancer setting. I’m also convinced that we’ll play a very important role there.”

That won’t come easy, though. Roche’s latest win in Phase III is its third in a matter of months, but with 5 checkpoints on the market, everyone is promising to play hard to beat the competition. And being first may be an advantage, but it’s no guarantee of market success. Merck is also expected to provide a read out in the same cancer segment soon from KEYNOTE-407.

“Squamous non-small cell lung cancer is difficult to treat and there have been limited new treatment options over the last few decades,” said Sandra Horning, Roche’s chief medical officer and head of global product development. “We will share the IMpower131 results with global health authorities and we look forward to seeing more mature overall survival data.”

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