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Tecentriq combo fails in advanced triple negative breast cancer

Tecentriq plus paclitaxel failed to improve progression-free survival


Roche’s hopes of extending its PD-L1 inhibitor Tecentriq into metastatic triple negative breast cancer (TNBC) have fallen flat after the drug failed to hit the primary endpoint in a pivotal phase 3 trial.

The phase 3 Impassion131 study evaluated Tecentriq (atezolizumab) in combination with paclitaxel chemotherapy in comparison to placebo plus chemotherapy.

The drug combination failed to achieve statistical significance on its primary endpoint of progression-free survival for the first-line treatment of people with advanced TNBC, whose tumours were PD-L1-positive.

Data for the secondary endpoint of overall survival also showed a negative trend, although Roche said the study was not powered for OS and the data was also immature at the time of analysis.

Roche plans to discuss the full results from the study with global health authorities and will be presented at an undisclosed future medical meeting.

“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," said Levi Garraway, chief medical officer and head of global product development at Roche.

"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,” he added.

TNBC is an aggressive and hard-to-treat subtype of breast cancer, representing around 15% of all breast cancer worldwide, totalling approximately 300,000 cases every year. Patients who are PD-L1 positive represent a subgroup of around 40% of this total.

Tecentriq has already been approved in combination with Abraxane (nab-paclitaxel), after demonstrating a statistically significant PFS benefit and clinically meaningful improvements in OS for people with metastatic TNBC whose tumours express PD-L1.

TNBC is an important niche for Roche’s checkpoint inhibitor, in a class that is otherwise dominated by Merck & Co’s PD-1 inhibitor Keytruda (pembrolizumab). Merck’s drug suffered a rare set back last year when it failed to show benefits compared to standard chemotherapy in advanced TNBC.

Despite the fail in TNBC, Keytruda is far ahead of its rivals in terms of revenues, bringing in $11bn last year alone. Much of those sales come from its dominant position in non-small cell lung cancer, where it has become a standard treatment for newly diagnosed patients.

Article by
Lucy Parsons

7th August 2020

From: Research



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