Pharma

Roche’s lung cancer data look good, so why didn’t the market react to clinical trial results?

Roche’s anti-PD-L1 drug Tecentriq took a step closer to regulatory approval as a combination drug for untreated non-small cell lung cancer patients. So why weren’t investors impressed?

Basel, Switzerland-based Roche has announced good news, with an update on its  IMpower150 trial. The data show that adding its anti-PD-L1 drug Tecentriq (atezolizumab) to a pair of older drugs reduced the risk of disease worsening or death by 38 percent for patients with advanced non-squamous non-small cell lung cancer (NSCLC).

Roche notes that this is the first time a combination immunotherapy trial has successfully increased progression-free survival (PFS) in this population, according to company news release. Approximately 18 percent of patients treated with a combination of Avastin and chemotherapy were progression-free at the 12-month mark — that number more than doubled to 37 percent when Tecentriq was added to the mix.

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Why then, were investors so unimpressed? By late afternoon, Roche’s stock was actually down 2.5 percent.

The pessimism is surely not a reflection of the market need. Lung cancer is the second most common form of cancer in both men and women, according to the American Cancer Society (ACS). More importantly, it is by far the leading cause of cancer death. Around 1 in 4 cancer deaths in the U.S. are attributed to lung cancer and it takes more lives than colon, breast, and prostate cancers combined.

With such a great market opportunity, Roche’s challenge may be competition.

A stunning 164 agents targeting PD-1/L1 are currently in development, a new report by the Cancer Research Institute (CRI) states. Of those, 50 are currently in clinical stage development, five are FDA-approved, and four are reportedly vying for the IMpower150 population.

Merck’s Keytruda, Bristol-Myers Squibb’s Opdivo, and AstraZeneca’s Imfinzi are all jostling with Tecentriq for a prime position. And it’s not an easy race to call, analysts at EP Vantage noted on Thursday.

For investors, Roche has left some major questions unanswered.

“The IMpower150 study had three arms: Tecentriq plus chemotherapy (arm A); Tecentriq plus Avastin plus chemotherapy (arm B); and Avastin plus chemotherapy (arm C). So far, complete data are only available comparing arm B with arm C – meaning that there is only preliminary information yet on how Tecentriq effectively stacks up against Avastin,” EP Vantage analysts stated.

In other words, is Avastin really doing the heavy lifting?

In many ways, that summarizes the current state of the immunotherapy field. With every dataset, new questions are unearthed. New patient subsets are considered. Those 50 anti-PD1/L1 agents in the clinic have now given rise to 1,502 studies, of which 1,105 are combination trials.

Many of these trials are small and operate around a single trial site or center, said Aiman Shalabi, CRI’s chief medical officer and director of the Anna-Maria Kellen Clinical Accelerator. That presents a challenge for investors and possibly the patient community, as companies pursue overlapping products and analyses.

“Innovation lives in academic centers, and CRI strongly encourages more research and clinical trials based on strong science and new targets to advance the field,” Shalabi wrote in an email forwarded by a CRI representative. “However, there are inefficiencies and duplication identified in the IO landscape analysis, such as the crowded PD-1/L1 studies.”

Shalabi supports the studies, but believes they should be done “more efficiently and collaboratively via multi-center collaboration and the use of innovative study designs such as basket and umbrella platforms to evaluate new combinations and enhance efficiencies across the landscape.”

In the meantime, information about these key drugs slowly drips out from many small studies that can’t be easily compared. That could help to explain why Roche’s data didn’t jolt the markets today.

Photo: goir, Getty Images