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Roche's Drugs, Trials, and FDA Approvals after 1H17

PART:
1 2 3 4 5 6 7 8 9 10 11
Part 2
Roche's Drugs, Trials, and FDA Approvals after 1H17 PART 2 OF 11

Could Tecentriq Be Roche’s Long-Term Growth Driver?

Recent approval and recognition

In July 2017, the EC’s (European Commission) CHMP (Committee for Medicinal Products for Human Use) recommended a positive opinion for Roche’s (RHHBY) Tecentriq as a monotherapy for the treatment of adult individuals with metastatic non-small cell lung cancer (or NSCLC) who had previously been treated with chemotherapy. The CHMP’s recommendations were based on the results of the Phase 2 POPLAR trial and the Phase 3 OAK trial.

The Phase 3 OAK trial evaluated the safety and efficacy of Tecentriq versus docetaxel for the treatment of individuals with squamous as well as non-squamous disease, irrespective of the programmed death-ligand 1 (or PD-L1) status of their tumors. In the OAK trial, 12-month overall survival (or OS) was 55.0% among patients on Tecentriq therapy compared to 41.0% for patients on docetaxel therapy. In the trial, the 18-month OS was 40.0% among patients on Tecentriq compared to 27.0% for patients on docetaxel.

Could Tecentriq Be Roche’s Long-Term Growth Driver?

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CHMP has also recommended a positive opinion for Tecentriq monotherapy for the treatment of adult individuals with metastatic urothelial carcinoma (or mUC) who have had a prior platinum-containing chemotherapy or are ineligible for cisplatin chemotherapy.

Tecentriq for bladder cancer

In May 2017, Roche presented an update on the Phase 3 IMvigor211 trial, which was conducted to evaluate the safety and efficacy of Tecentriq in individuals with locally advanced or mUC who had disease progression during or following platinum-containing chemotherapy. Roche said that the Phase 3 IMvigor 211 trial did not meet its primary endpoint of OS compared to chemotherapy, but the safety profile of the drug was maintained.

Roche’s peers in the NSCLC drugs market include Bristol-Myers Squibb (BMY), Merck & Co. (MRK), Eli Lilly (LLY), and AstraZeneca. The Vanguard Total International Stock ETF (VXUS) invests ~0.70% of its total portfolio holdings in Roche Holding.

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