Roche Holdings RHHBY announced that the phase III study, IMpower133, on immuno-oncology drug, Tecentriq, met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) at its first interim analysis for the indication of extensive-stage small cell lung cancer (ES-SCLC).
The study enrolled 403 people who were randomised equally (1:1) to receive either Tecentriq in combination with carboplatin and etoposide (Arm A), or placebo in combination with carboplatin and etoposide (Arm B, control arm).
The results of the study showed that initial (first-line) treatment with the combination of Tecentriq and chemotherapy (carboplatin and etoposide) enabled patients with ES-SCLC live significantly longer compared to chemotherapy alone. The combination also reduced the risk of disease worsening or death (PFS) compared to chemotherapy alone.
IMpower133 met its OS and PFS co-primary endpoints as per the study protocol. At present, Roche has eight ongoing phase III lung cancer studies, which are evaluating Tecentriq alone or in combination with other drugs. Among these, this is the fourth phase III study, evaluating Tecentriq combination study, to come out with data and the fifth one to demonstrate positive results.
We note that Tecentriq is already approved in the United States and European Union for patients with previously-treated metastatic NSCLC and for patients with locally advanced or metastatic urothelial cancer (mUC), who are not eligible for cisplatin chemotherapy or who have had disease progression during or following platinum-containing therapy.
Roche plans to submit the data to the regulatory bodies. Per the company, IMpower133 is the first phase III study with an immunotherapy-based combination to show improvement in OS and PFS in the initial treatment of extensive-stage small cell lung cancer (ES-SCLC) which increases the likelihood of a potential approval.
The label expansion of the drug will boost sales.
Meanwhile, the FDA has accepted for priority review of Bristol-Myers Squibb Company’s BMY supplemental Biologics License Application for Opdivo for the indication of SCLC, whose disease has progressed after two or more prior lines of therapy. The FDA’s action date is Aug 16, 2018.
Hence, competition will be stiff in the SCLC market for Roche.
Roche’s stock has lost 9.3% so far this year, as against the industry's decline of 2.5%.
Approval of new drugs and a potential label expansion of existing drugs bode well for Roche as its legacy drugs like Herceptin and MabThera are facing competition from biosimilars.
Novartis NVS has already launched its biosimilar version of Rituxan/ MabThera in Europe. Amgen AMGN obtained FDA approval for a biosimilar version of Avastin for treatment of five types of cancers including lung cancer, colorectal cancer, glioblastoma, renal cell carcinoma and cervix cancer.
Zacks Rank
Roche currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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