Roche RHHBY announced that the late-stage study on Tecentriq in combination chemotherapy (including Abraxane) met its primary endpoint.
The IMpassion031 study is a phase III, multicenter, randomized, double-blind study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (Abraxane, albumin-bound paclitaxel; nab-paclitaxel; followed by doxorubicin and cyclophosphamide) compared to placebo plus chemotherapy in previously untreated, early triple-negative breast cancer (TNBC) patients.
The study met its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in pathological complete response (pCR) for the treatment of these patients, regardless of PD-L1 expression.
The safety profile for the Tecentriq combination appeared to be consistent with the known safety profiles of the individual medicines.
The results of the study will be discussed with global health authorities, including the FDA and the European Medicines Agency (EMA).
Tecentriq in combination with nab-paclitaxel is already approved in the United States and Europe for the treatment of adults with unresectable, locally-advanced or metastatic TNBC in people whose tumors express PD-L1.
Meanwhile, Roche is also evaluating Tecentriq in multiple ongoing and planned phase III studies across lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. These include studies evaluating the drug both alone and in combination with other medicines.
Tecentriq was approved by the FDA as a first-line monotherapy for certain patients with metastatic non-small cell lung cancer (NSCLC), whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
The label expansion into additional indications will boost sales of the drug, which came in at CHF 644 million in the first quarter.
Roche’s stock has gained 12.2% in the year so far against the industry’s decline of 0.3%.
However, the drug faces stiff competition from Merck’s MRK Keytruda and Bristol-Myers’ BMY Opdivo. Other PD-L1 inhibitors available in the market include AstraZeneca’s AZN Imfinzi.
Roche currently carries a Zacks Rank #3 (Hold). You can see the complete listof today’s Zacks #1 Rank (Strong Buy) stocks here.
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