MUNICH—On Monday at the European Society for Medical Oncology 2018 Congress, new data showed that Roche’s Tecentriq, in tandem with chemo, could improve survival for newly diagnosed lung cancer patients. But what they didn’t show may be just as important, one executive figures.
In the phase 3 Impower130 study, a pairing of Roche’s immuno-oncology contender plus Celgene chemo drug Abraxane helped people live a median 18.6 months, a statistically significant improvement over the 13.9 months solo chemo produced. Tecentriq also pared down the risk of disease worsening or death by 36%, Roche said.
The study was an important one for showing that Tecentriq “can combine with multiple types of chemo” and still produce benefits, and also that Tecentriq can improve outcomes for patients with all levels of biomarker PD-L1, Alan Sandler, M.D., Roche’s global head of lung and head and neck cancer, said. But “I think its other importance is actually in some of the things it didn’t do” that another phase 3 trial—dubbed Impower150—did.
That study, which combined Tecentriq with chemo and older Roche drug Avastin, showed benefits in patients with EGFR and ALK mutations, something I-O studies for other agents have yet to do. It also produced a survival advantage in patients with liver metastases “whose disease is even more difficult to treat than the average patient with non-small cell lung cancer,” Sandler said, once again making it the only study so far that’s “able to report that particular outcome.”
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In Impower130, “the fact is that we didn’t see the same benefit in patients with mutations” or metastases, which “sort of confirmed that issue, that Avastin plays an important role and may be unique to that combination with Tecentriq,” Sandler said. And that’s just fine by Roche, which is looking to both find niches in the lung cancer market and breathe new life into Avastin before biosimilar challengers hit.
The Swiss pharma giant is already tracking toward a blockbuster approval in extensive-stage small cell lung cancer after posting positive data this June. And the way Sandler sees it, if the Tecentriq-Avastin-chemo regimen can become the treatment of choice in patients with liver metastases and EGFR and ALK mutations—post-treatment with a tyrosine kinase inhibitor—Roche could wind up with a decent-sized slice of the pie.
“That’s really a potential 30%, 35% of the lung cancer population, which is, I think, a pretty significant portion to be impacting patient lives,” he said.
At one point, analysts thought Roche might be able to challenge leader Merck in the lung cancer market, with both companies trialing PD-1/PD-L1 drugs in tandem with chemo. But Merck, which now bears two approvals in the all-important first-line setting compared with its rivals’ zero, has gone on to widen its lead with stellar survival results, leaving competitors looking for smaller pockets of the market that they can control.
Meanwhile, Bristol-Myers Squibb, another company once seen as having a shot to take Merck’s lung cancer crown, recently hit a delay in its quest for a first-line nod of its own. The company submitted a new survival analysis—results of which Credit Suisse’s Vamil Divan, M.D., called “disappointing” in a note to clients—to regulators in the U.S. and EU, delaying their decisions on Bristol-Myers’ combo of PD-1 drug Opdivo and CTLA4 drug Yervoy.