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Roche's Tecentriq Study Meets Co-Primary Endpoints for NSCLC

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Roche (RHHBY - Free Report) announced that the phase III study, IMpower130 on immunotherapy Tecentriq, met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS).

The multicentre, open-label, randomized study evaluated the efficacy and safety of Tecentriq in combination with carboplatin and nab-paclitaxel versus only chemotherapy in chemotherapy-naïve patients with stage IV non-squamous non-small cell lung cancer (NSCLC).

The study results showed that the combination of Tecentriq plus chemotherapy (carboplatin and Abraxane [albumin-bound paclitaxel; nab-paclitaxel]) helped patients live significantly longer compared to chemotherapy alone in the first-line treatment of advanced non-squamous NSCLC. Moreover, the Tecentriq combination reduced the risk of disease worsening or death (progression-free survival or PFS) as compared to chemotherapy alone.

We note that Tecentriq is already approved in the United States and European Union for 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.

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 third phase III study evaluating Tecentriq alone or in combination to demonstrate an OS benefit for people with NSCLC, which has demonstrated positive results.

The label expansion of the drug will boost sales.

However, competition is stiff in the NSCLC market with the likes of Merck’s (MRK - Free Report) Keytruda and Bristol-Myers Squibb Company’s (BMY - Free Report) Opdivo.

Roche’s stock has lost 17.3% over a year, as against the industry's gain of 4.7%.


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 - Free Report) has already launched its biosimilar version of Rituxan/ MabThera in Europe. The FDA also approved 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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