Tecentriq passes neoadjuvant breast cancer trial as Roche looks for early start on the next big checkpoint opportunity
Shot through hundreds of trials over the last decade, checkpoint inhibitors have proven a versatile tool. First approved for melanoma, collectively they now cover dozens of cancer types and settings, earning their developers billions in the process.
Largely, though, they have avoided use in one of the most common settings: Localized tumors typically treated with adjuvant or neo-adjuvant therapy. For drug companies, Cowen estimated last October, it’s a potential $110 billion market, one they’re rapidly trying to fill. The firm noted a long list of trials were underway and due to start reading out — for breast cancer at least — this September with a Roche study in neoadjuvant-stage triple-negative breast cancer.
That trial has now read out ahead of expectations. And the results, Roche’s biotech subsidiary Genentech said, are positive.
Known as IMpassion031, the Phase III study enrolled early-stage triple-negative breast cancer patients who were scheduled for surgery and gave them either Roche’s PD-L1 therapy Tecentriq plus the chemotherapy Abraxane or simply chemotherapy alone. The question was whether patients taking Tecentriq were more likely to have a pathological complete response — i.e. were more likely to show no signs of tumor tissue when they went in for surgery.
The answer was yes, Roche said, though data have yet to be released. The study began in 2017 and aimed to enroll 324 patients, according to clinicaltrials.gov. The benefit was seen regardless of whether a patient was PD-L1 positive, Roche said.
Last year, Tecentriq became the first immunotherapy approved for triple-negative breast cancer — a common tumor type that has long eluded advanced therapies because patients’ tumors don’t express high quantities of the receptors targeted drugs go after. That approval, though, was only for metastatic patients who are PD-L1 positive.
Among checkpoint inhibitors, Roche has traditionally lagged behind Merck’s Keytruda and Bristol Myers Squibb’s Opdivo, but the Swiss pharma could find a significant niche treating these early tumors.
The next such breast cancer trial Cowen expects to reach primary completion is IMpassion050, for neoadjuvant and adjuvant HER2-positive breast cancer. The company is also running a colorectal adjuvant trial due to read out soon. A renal adjuvant trial may not finish until 2022 but is projected to be the first checkpoint study to read out in that setting.
They’ll be far from alone, though. Along with Roche, AstraZeneca, Bristol Myers, and Eli Lilly may all put out data later this year in adjuvant or neoadjuvant lung cancer. Merck, traditionally the leader in the checkpoint field with Keytruda, has several trials set to read out in the longer term, between 2022 and 2027.
Success, too, is far from a guarantee. The first adjuvant trial Cowen expected to read out was IMvigor010, testing Tecentriq in a form of non-metastatic bladder cancer. They were right. A readout came in late January. The results, however, were negative.
