Industry watchers have pegged PD-1/L1 cancer immunotherapies’ next phase of growth on their potential in the pre- and post-surgery settings. And Roche has claimed the first win for such a use in the all-important non-small cell lung cancer arena.
The Swiss pharma’s Tecentriq topped best supportive care at preventing cancer recurrence or death among patients with stage II to IIIA non-small cell lung cancer who had had their tumors surgically removed and received chemotherapy after surgery, Roche’s Genentech said Monday.
With that first-in-class win, Roche is taking the so-called disease-free survival data to regulatory authorities, including the FDA and the European Medicines Agency. Assuming it could take 25% market share, Jefferies analyst Peter Welford estimated that Tecentriq could reap $1.2 billion in peak sales from this treatment setting.
However, physicians might not be willing to use the drug as an adjuvant treatment after surgery until more mature life extension results are available, Welford said in a Monday note to investors.
Citing a recent survey of 25 U.S. oncologists, Welford noted that almost all—96%—of the physicians said they wouldn’t consider using a PD-1/L1 therapy in the adjuvant setting based solely on disease-free survival data before an agent shows a clear benefit in extending patients’ lives. Although the FDA has in the past cleared adjuvant cancer therapies based on disease-free survival data, there’s been an ongoing debate over whether that’s a good indicator of overall survival.
A “world pre-eminent lung cancer expert” also expressed a similar view, saying that physicians would await overall survival data unless there was “striking” disease-free survival, similar to what AstraZeneca’s targeted lung cancer drug Tagrisso posted last year, according to Welford.
The bar is very high. In the phase 3 Adaura trial, Tagrisso cut the risk of disease recurrence or death by a whopping 83% compared with placebo in stage II and IIIA, EGFR-mutant NSCLC. It snagged an FDA go-ahead for that indication in late 2020.
For now, the exact magnitude of Tecentriq’s disease-free survival win, from the phase 3 IMpower trial, remains under wraps, but Roche noted the benefit was more pronounced in those with PD-L1-positive tumors. The study will continue to examine disease-free survival in the overall trial population—which also includes stage IB patients—as well as the key survival data, both of which weren’t mature at the time of analysis.
“With these landmark results, Tecentriq has become the first cancer immunotherapy to help many people with resectable early lung cancer live longer without their cancer returning,” Roche’s chief medical officer, Levi Garraway, said in a statement. “We’re excited by the clinical benefit adjuvant Tecentriq may bring to lung cancer patients, particularly in the PD-L1-positive population. We will submit these data to regulatory authorities as soon as possible.”
But Tecentriq’s first-mover advantage may be short-lived, Welford noted. Merck & Co.’s Keytruda, currently the PD-1/L1 king in metastatic NSCLC, is also expected to report adjuvant data in early-stage NSCLC this year from the Keynote-091 trial. And Welford’s physician survey and feedback from that industry opinion leader pointed to a clear preference for Keytruda among existing PD-1/L1s in this setting.
In addition, a phase 3 trial run by the National Cancer Institute study testing Bristol Myers Squibb’s Opdivo as an adjuvant therapy for early-stage NSCLC could also read out this year.