Roche (RHHBY - Free Report) announced positive data on the immuno-oncology drug, Tecentriq (atezolizumab), from a late-stage study in patients with advanced non-small cell lung cancer (NSCLC).
The phase III IMpower110 study evaluated Tecentriq as a first-line (initial) monotherapy compared with cisplatin or carboplatin and pemetrexed or gemcitabine (chemotherapy) in advanced NSCLC without ALK or EGFR mutations (Wild-Type or WT).
An interim analysis showed that the study met its primary endpoint. Tecentriq monotherapy demonstrated a statistically significant overall survival (OS) benefit in patients with high PD-L1 expression (TC3/IC3-WT) compared with only chemotherapy.
The safety of the drug was consistent with its known safety profile and no new safety signals were identified.
Hence, the study will continue until a final analysis is conducted in patients with lower levels of PD-L1 expression.
These new data further reinforce Tecentriq’s ability to treat this set of patients. Roche will submit these data to the FDA and the EMA and also present the same at an upcoming medical congress.
We remind investors that Tecentriq is already approved in the United States and Europe either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and PD-L1-positive metastatic triple-negative breast cancer.
The label expansion will boost sales of the drug, which posted 141% growth in sales in the first half of 2019, driven by the new indications of triple-negative breast cancer and extensive-stage small cell lung cancer.
Presently, Roche has nine phase III lung cancer studies underway, evaluating Tecentriq as a monotherapy or in combination with other medicines across different types of lung cancer. Apart from lung cancer, Tecentriq is being evaluated in multiple ongoing and planned phase III studies across genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers either as a monotherapy or in combination with other therapies.
While the market of NSCLC present immense potential, competition is stiff in this space. Immuno-oncology therapies like Merck’s (MRK - Free Report) Keytruda, AstraZeneca’s (AZN - Free Report) Imfinzi and Bristol-Myers’ (BMY - Free Report) Opdivo are approved for various types of lung cancer.
Concurrently, Roche presented positive phase III SAkuraStar study results for pipeline candidate satralizumab as monotherapy for neuromyelitis optica spectrum disorder (NMOSD) at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
Satralizumab targets the interleukin-6 (IL-6) receptor, a key driver of rare, debilitating central nervous system disorder, NMOSD. The study results showed that satralizumab monotherapy achieved a 55% reduction in the risk of relapses compared to placebo in the overall population (NMOSD patients). Results also showed that there was a 74% reduction in the risk of relapse for satralizumab monotherapy as compared to placebo in NMOSD patients.
Shares of Roche have gained 9.1% so far this year against the industry’s decline of 1.2%.
Roche’s efforts to develop its portfolio beyond oncology have been impressive. The company currently has a dozen investigational drugs in development for diseases like multiple sclerosis, Alzheimer’s disease, Huntington’s disease, spinal muscular atrophy, Parkinson’s disease and autism.
Roche currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
(We are reissuing this article to correct a mistake. The original article, issued on September 12, 2019, should no longer be relied upon.)