Roche Holdings (RHHBY - Free Report) announced that the phase III IMpower132 study on immuno-oncology drug, Tecentriq, met its co-primary endpoint of progression-free survival (PFS).
The phase III, open-label, randomised study (n=568) evaluated the efficacy and safety of Tecentriq plus chemotherapy (cisplatin or carboplatin and Alimta) versus chemotherapy alone in chemotherapy-naïve patients suffering from non-squamous non-small cell lung cancer (NSCLC).
The results showed that the combination of Tecentriq in addition to chemotherapy (cisplatin or carboplatin plus pemetrexed) reduced the risk of disease worsening or death (PFS) compared to chemotherapy alone in the initial (first-line) treatment of advanced NSCLC.
In addition, a numerical improvement for the co-primary endpoint of overall survival (OS) was observed, but the statistical significance was not met at this interim analysis.
Hence, the study will continue as planned and the final OS results from the study are expected in 2019.
Roche expects to present the data at an upcoming medical meeting.
We note that Tecentriq is already approved in the United States and Europe for patients suffering from previously treated metastatic NSCLC and certain types of untreated or previously treated metastatic urothelial carcinoma (mUC).
The encouraging results on Tecentriq for the first-line treatment of NSCLC is positive, given the market potential. Roche has eight ongoing phase III lung cancer studies, which are evaluating Tecentriq alone or in combination with other drugs.
NSCLC market holds great promise, particularly for the first-line treatment, but competition is stiff as well with the likes of Merck’s (MRK - Free Report) Keytruda and Bristol-Myers Squibb Company’s (BMY - Free Report) Opdivo.
Approval of new drugs and label expansion of existing key drugs bode well for Roche, given its current challenges.
Year to date, shares of Roche have declined 4.5% against the industry’s growth of 1.9%. Roche’s legacy drugs like Herceptin and MabThera are facing competition from biosimilars. Novartis (NVS - Free Report) has already launched its biosimilar version of Rituxan/ MabThera in Europe.
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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