Roche’s Tecentriq Fails in Phase 3 Breast Cancer Trial

Roche recently announced that a Phase 3 study evaluating its lung cancer drug, Tecentriq, combined with chemotherapy, did not meet its primary endpoint for treatment of metastatic triple-negative breast cancer (TNBC) with expressed PD-L1 compared to placebo.

The data for the secondary endpoint of overall survival also showed a negative trend. But researchers noted that the study was not focused for the secondary endpoint of overall survival and data was not developed enough at the time of analysis. 

The safety profile for Tecentriq combination was consistent with the known safety of the individual medicines and no new safety signals were found.

Overall survival follow-up will continue until final analysis, researchers said.

“While we are disappointed by the results from the IMpassion131 study, we are grateful for all the patients, families and physicians who were involved in the study," Levi Garraway, MD, PhD, Roche's chief medical officer and head of global product development, said in the announcement. 

“Today’s results underscore the need to better understand the cancer and immune system interactions, including the chemotherapy backbone and associated regimens. We remain committed to finding optimal treatments for all people living with this aggressive disease.”

Previously, Roche’s Impassion 130 study found that Tecentriq in combination with Abraxane showed improved overall survival for individuals with metastatic TNBC whose tumors expressed PD-L1.

And Tecentriq in combination with nab-paclitaxel (chemotherapy) is approved in more than 70 countries for the treatment of adults with unresectable or metastatic TNBC expressed PD-L1.

Back in May, FDA approved Tecentriq for adult patients with metastatic non-small cell lung cancer.

Tecentriq is the fourth indication in metastatic non-small cell lung cancer and the fifth indication in lung cancer overall in the US.

The approval was based on results from Roche’s clinical trial, IMpower110, a multicenter, international, open-label trial for patients with stage IV non-small cell lung cancer whose tumors express PD-L1 and who had received no prior chemotherapy for metastatic disease.

Specifically, Researchers found that Tecentriq improved overall patient survival by 7.1 months compared with chemotherapy.

Median survival was 20.2 months for patients for Tecentriq compared with 13.1 months for chemotherapy. 

Additionally, median progression-free survival per investigator was slightly more than eight months for Tecentriq and five months for the platinum-based chemotherapy. 

Overall response rate per investigator was 38 percent and 29 percent, respectively. 

And most recently, FDA approved Tecentriq for the treatment of individuals with unresectable or metastatic hepatocellular carcinoma who have not received prior therapy. 

The approval of the drug was conducted under FDA’s Project Orbis initiative, which reviews oncology medicines among international partners and may allow cancer patients to receive earlier access to products in other countries.

The FDA approval was based on results from the Phase III IMbrave150 study, which demonstrated that Tecentriq, in combination with Avastin, reduced the risk of death by 42 percent and decreased the risk of disease worsening or death 41 percent, compared with sorafenib.

“For the first-time we have a regimen that markedly improves survival over sorafenib, the standard of care for first-line hepatocellular carcinoma since 2007, and offers patients the opportunity for improved disease control with a favourable tolerability profile,” said Richard Finn, MD, professor of medicine at the David Geffen School of Medicine at UCLA and director of the signal transduction and therapeutics program at the UCLA Jonsson Comprehensive Cancer Center.

Aside from the FDA approvals, Roche mentioned that it currently has a development program for Tecentriq which includes ongoing and planned Phase III studies across several types of lung, genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers.