Roche Holding AG (RHHBY - Free Report) announced encouraging interim data from a phase III study – IMpower150 – evaluating Tecentriq combination regimen for the first-line treatment of metastatic non-squamous non-small cell lung cancer ("NSCLC"). Data showed that its immuno-oncology drug, Tecentriq, in combination with its another blockbuster cancer drug Avastin plus carboplatin and paclitaxel, significantly improved median overall survival (“OS”) rate by 4.5 months compared to Avastin plus chemotherapies.
The Tecentriq combination regimen showed survival benefit in key lung cancer populations such as people with EGFR- and ALK-positive mutations and those with liver metastases and those with varying levels of PD-L1 expression.
In November last year, Roche’s IMpower 150 study met the co-primary endpoint of progression free survival (“PFS”) benefit. In March this year Roche announced that the study also met its another primary endpoint of median OS. However, Roche did not provide any OS numbers.
Detailed data from the study will be presented at the annual meeting of the American Society of Clinical Oncology ("ASCO") early next month.
We remind investors that the combination regimen is already under priority review in the United States for this indication in the first-line setting. A supplemental Biologics License Application was filed based on PFS and OS data from the IMpower 150 study. A decision is expected on Sep 5, 2018. The positive data from the IMpower150 study is likely to boost prospects of a favorable decision by the FDA. The drug is approved for NSCLC in second-line setting.
We note that Merck’s (MRK - Free Report) Keytruda is the only immuno-oncology drug approved alone or in combination with Eli Lilly’s (LLY - Free Report) Alimta (pemetrexed) and carboplatin for treating NSCLC patients in first-line setting.
Shares of Roche have lost 10.3% year to date compared with the industry’s decline of 4%.
The IMpower150 study consisted of three cohorts, evaluating Tecentriq in combination with Avastin, carboplatin and paclitaxel, Tecentriq in combination with only carboplatin and paclitaxel, and Avastin plus carboplatin and paclitaxel in NSCLC patients. Data showed that the Tecentriq-Avastin arm achieved median OS, a co-primary endpoint, of 19.2 months compared with 14.7 months for Avastin arm.
However, Tecentriq plus chemotherapies did not achieve any statistically significant improvement in OS compared to Avastin plus chemotherapies.
Roche is evaluating Tecentriq as monotherapy or in combination regimens in eight late-stage studies including IMpower 150.
In a separate press release, Roche announced follow-up data from the phase III ALEX study comparing Alecensa to Pfizer’s (PFE - Free Report) Xalkori (crizotinib) in treatment-naive ALK-positive NSCLC patients. Data from the study demonstrated long-term PFS benefit when treated with Alecensa with median PFS almost tripling to 34.8 months compared to 10.9 months for Xalkori.
Roche currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.
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