Tecentriq gets its narrow breast cancer label

US approval of Roche’s Tecentriq plus Abraxane in triple-negative breast cancer marks a first for an anti-PD-(L)1 drug, but also leaves an opportunity for Merck & Co’s Keytruda. This is because Tecentriq has been restricted to patients with at least 1% PD-L1 expression, based on interim results of the Impassion-130 trial showing these subjects to be driving the survival benefit (Esmo 2018 – Roche misses the bullseye in triple-negative breast cancer, October 20, 2018). Attention now turns to Keynote-119, a Keytruda study due to read out next month. However, it might be a tall order to expect this to show a benefit in PD-L1 non-expressers as it tests Keytruda as monotherapy; a better bet for Merck might be the Keynote-355 chemo combo trial due to yield data around the year end. And there are other Roche studies reading out that could bolster the Swiss group’s position, as well as acting to confirm Friday’s accelerated approval, which was backed by Impassion-130’s progression-free survival data. Tecentriq’s breast cancer label is in theory conditional on it showing an overall survival benefit, though in practice the chances of an accelerated approval being revoked are slim.

Phase III studies of anti-PD-(L)1 MAbs in triple-negative breast cancer*
Company Study Project Setting Trial ID Data?
Roche Impassion-130 Tecentriq + Abraxane vs Abraxane NCT02425891 Interim reported
Roche Impassion-131 Tecentriq + paclitaxel vs paclitaxel NCT03125902 Feb 2019
Merck & Co Keynote-119 Keytruda Monotherapy vs chemo NCT02555657 Apr 2019
Roche Impassion-132 Tecentriq + chemo vs chemo NCT03371017 Jul 2019
Merck & Co Keynote-355 Keytruda + chemo vs chemo NCT02819518 Dec 2019
Shanghai Junshi Biosciences Keystone JS001 + Abraxane vs Abraxane NCT03777579 Dec 2019**
Source: clinicaltrials.gov. Notes: *excludes trials in the (neo)adjuvant setting; **seems unlikely as trial has yet to start enrolment.

Share This Article