[Corrected 10:15 a.m., 11/20/17. See below.] Roche’s Genentech division reported this morning that its cancer immunotherapy drug, atezolizumab (Tecentriq), has succeeded in a clinical study that could help change the standard of care for people with a certain type of lung cancer.
The South San Francisco, CA-based Genentech said late Sunday night that in a trial of 1,202 patients just diagnosed with non-small cell lung cancer, atezolizumab, when combined with chemotherapy and another one of its cancer drugs, bevacizumab (Avastin), held the tumors in check longer than bevacizumab and chemotherapy alone. Progression-free survival, as it is known, is one of the two main goals of the Phase 3 trial, called IMpower150. [This paragraph has been corrected. A previous version gave the wrong type of lung cancer.]
It’s important to note what Genentech didn’t disclose, as well. First, it didn’t specify the magnitude of the benefit produced by the combination. Second, it didn’t discuss the side effects except to report that they were “consistent with the known profile” of each of the medicines and offered no new surprises. As promising as new immunotherapies like atezolizumab have been, the side effects in combination with other agents have been disconcerting, as Xconomy reported earlier this year.
A third important marker in the study has yet to be reported. Genentech said its clinicians have not yet had enough time to evaluate the second main goal of the trial: How much longer participants on atezolizumab-bevacizumab-chemotherapy live than those on chemotherapy and bevacizumab. The company said “initial observations… are encouraging,” however, and will analyze the data again in the first half of 2018.
Despite the incomplete picture reported publicly, Genentech will submit study data to U.S. and European regulators. That means atezolizumab could shake up the treatment landscape in patients with advanced NSCLC. “Roche is now a real competitor in first-line lung [cancer],” wrote ISI Evercore analyst Umer Raffat in a note to investors Monday morning.
Roche (OTCMKTS: RHHBY) shares surged more than six percent in pre-market trading Monday morning.
Lung cancer is the second most common cause of cancer, behind skin cancer, and is the leading cause of cancer-related deaths, according to the American Cancer Society. The ACS predicts 222,500 new cases and 155,780 deaths from the disease this year alone. NSCLC is the most common form of lung cancer, accounting for 80 to 85 percent of cases, according to the ACS.
Cancer immunotherapy drugs have been working their way forward as important treatments for a variety of cancers. Lung cancer is a particularly competitive field. Merck’s (NYSE: MRK) pembrolizumab is, as of now, the only approved immunotherapy drug for newly diagnosed NSCLC patients, while Bristol-Myers Squibb’s (NYSE: BMY) nivolumab (Opdivo) and atezolizumab are approved for those who have failed prior treatment.
To bypass Merck, companies are looking to combinations. Bristol has a lot riding on a study called Checkmate-227, which tests a combination of nivolumab and its other approved immunotherapy, ipilimumab (Yervoy), in newly diagnosed NSCLC patients. Data are expected next year. AstraZeneca (NYSE: AZN) has its own immunotherapy combination, but it produced disappointing Phase 3 data earlier this year.
Merck has an important combination trial of its own on the way, called Keynote-189, which tests pembrolizumab alongside chemotherapy and is expected to wrap up in 2019.
The atezolizumab combination represents an opportunity for Roche and its Genentech division to gain ground. When the drug was first approved in October 2016, it was the fourth so-called checkpoint inhibitor to come to market, behind nivolumab and ipilimumab from Bristol-Myers Squibb and pembrolizumab from Merck. Since then, nivolumab ($1.3 billion in 2016 sales) and pembrolizumab ($1.4 billion) have become blockbusters while atezolizumab (roughly $159 million) has been playing catch-up. The drug is in clinical testing for cancers of the kidney, breast, colorectal, prostate, and more, and has had up and down moments. Though approved for bladder cancer on an accelerated basis, for instance, it failed a Phase 3 trial for the disease earlier this year.
Separately, Genentech announced positive data from a third Phase 3 trial of hemophilia drug emicizumab (Hemlibra), which the FDA just approved last week. Here’s more on the drug and the significance of the trial, called Haven-3.