Roche drops triple-negative breast cancer from Tecentriq's US label

Roche announced Friday that it has voluntarily withdrawn Tecentriq (atezolizumab) for the treatment of PD-L1-positive, metastatic triple-negative breast cancer (mTNBC) in the US market. Roche noted that the decision is "not related to any changes in the efficacy or safety" of Tecentriq, and only impacts the mTNBC label in the US, not any other approved indications for the drug, either in the US or elsewhere.

Tecentriq became the first immunotherapy to be cleared for mTNBC when the FDA granted an accelerated approval in 2019 based on "highly encouraging" progression-free survival data from the Phase III IMpassion130 study. However, continued approval hinged on the IMpassion131 trial, a post-marketing requirement in which the combination of Tecentriq plus chemotherapy failed to show a survival benefit in PD-L1-positive patients being treated in the first-line setting.

In April, an FDA advisory panel that met to review six accelerated approvals for checkpoint inhibitors voted 7 to 2 in favour of keeping the one granted to Tecentriq in TNBC. Roche stated that since then, it has been working with the FDA on a possible alternative post-marketing requirement to IMpassion131, but due to "recent changes in the treatment landscape, the [agency] no longer considers it appropriate to maintain the accelerated approval."

Follows recent Keytruda approvals in TNBC

Last month, the FDA granted full approval to Merck & Co.'s Keytruda (pembrolizumab) plus chemotherapy for patients with locally recurrent unresectable or metastatic TNBC whose tumours express PD-L1. At the same time, it also cleared Keytruda for high-risk early-stage TNBC based on pathological complete response data from the Phase III KEYNOTE-522 study, as well as updated results showing it improved event-free survival as well.

In another late-stage study, KEYNOTE-355, first-line Keytruda plus chemotherapy significantly boosted overall survival compared to chemotherapy alone in patients with mTNBC whose tumours express PD-L1 with a combined positive score ≥10 (see ViewPoints: Keynote-355 hammers home Keytruda’s advantage in TNBC).

Meanwhile, earlier this year, Roche also pulled the US indication for Tecentriq in prior-platinum-treated metastatic urothelial carcinoma after follow-up studies failed to meet goals, citing the "rapidly" evolving treatment landscape there, too.

To read more Top Story articles, click here.