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May 10, 2017

Roche PD-L1 mAb Misses Primary Endpoint in Phase III Urothelial Carcinoma Study

  • A Phase study evaluating Roche’s anti-programmed death ligand 1 (anti-PD-L1) humanized monoclonal antibody (mAb) Tecentriq® (atezolizumab) failed to meet its primary overall survival endpoint in patients with locally advanced or metastatic urothelial cancer (mUC) that had progressed during or following treatment with a platinum-based chemotherapy. The antibody was granted accelerated approval by the FDA for the mUC indication in May last year.

    News that Tecentriq failed in the IMvigor211 study comes just hours after Merck KGaA and Pfizer confirmed the FDA granted accelerated approval for their fully human anti-PD-L1 mAb Bavencio® (avelumab) for the mUC indication.

    Commenting on the IMvigor211 study results, Sandra Horning, M.D., Roche’s CMO and head of Global Product Development, said the trial data will be discussed with the health authorities. “While these results are not what we had expected, we believe that Tecentriq will continue to play an important role in the treatment of people with advanced bladder cancer."

    The IMvigor211 study evaluated the efficacy and safety of Tecentriq compared with chemotherapy (vinflunine, paclitaxel, or docetaxel) in 931 patients with previously treated mUC who progressed during or following a platinum-based regimen. Roche said data from the study were consistent with those from the Phase II IMvigor210 study in similar patients, but that the IMvigor211 chemotherapy arm results were better than the study design assumptions.

    Based on the MIvigor210 data, the FDA granted Tecentriq accelerated approval last year for the treatment of people with locally advanced or mUC who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). The pivotal IMvigor211 study was designed to convert the accelerated approval to full approval in the U.S. and to support full approval globally.

    Just last month, the  FDA granted accelerated approval for Tecentriq as a treatment for patients with mUC who are not eligible for cisplatin chemotherapy. Tecentriq was separately approved by the FDA in October of last year for treating metastatic non-small-cell lung cancer (NSCLC) in patients demonstrating disease progression during or following platinum-containing chemotherapy and whose disease progressed on an appropriate FDA-approved targeted therapy if their tumor had epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) gene abnormalities. Approval for the NSCLC was based on data from the Phase III OAK and Phase II POPLAR studies.

    The clinical development program for Tecentriq either as monotherapy or as part of combination therapy includes more than 30 ongoing trials,17 of which are in progress or planned Phase III studies in lung, kidney, skin, breast, colorectal, prostate, ovarian, bladder, and blood cancers. This includes trials evaluating Tecentriq alone and in combination with other medicines.
     

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