Roche nixes Tecentriq trial in early breast cancer, but it's 'still in the game' in key lung cancer use: exec

Roche’s plans for expanding Tecentriq in early-stage cancers have hit a snag. But the company’s newly minted pharma chief remains hopeful for an important trial in resectable lung cancer.

Roche has pulled the plug on the phase 3 IMpassion030 trial testing Tecentriq in combination with taxane-based chemo as a postsurgical adjuvant therapy in triple-negative breast cancer (TNBC), the company said in an investor presentation (PDF) detailing its first-quarter results.

The company discontinued the trial after an independent data monitoring committee, at an interim analysis, found the study wasn’t likely to succeed, Roche Pharmaceuticals CEO Teresa Graham told reporters on a call Wednesday.

The trial failure didn’t come as a complete surprise, given a combination of Tecentriq and paclitaxel previously failed to improve outcomes for patients with PD-L1-positive metastatic TNBC in the IMpassion131 trial. That phase 3 setback, plus pressure from the FDA, led Roche to voluntarily withdraw its accelerated approval for Tecentriq in combination with Bristol Myers Squibb’s Abraxane, or nab-paclitaxel, in 2021.

Still, the negative IMpassion030 readout adds to a tough start for Tecentriq in early-stage cancers.

Another study called IMBrave050 hit its primary endpoint earlier this year, showing the combination of Tecentriq and Roche's Avastin significantly reduced the risk of recurrence or death compared with pure surveillance in the adjuvant liver cancer setting. But detailed data from an interim analysis revealed an early trend suggesting the combo might harm patient life expectancy. The overall survival data are immature, but the concerning signal could spell trouble for a potential FDA application.

Meanwhile, Roche is expecting two more readouts for Tecentriq in early cancers in the near term. For one, the company expects phase 3 results from the IMvoke010 trial in adjuvant head and neck cancer in the second half of this year.

But the most important trial is perhaps IMpower030. The study is testing Tecentriq both before and after surgery in early-stage non-small cell lung cancer (NSCLC).

Both AstraZeneca’s Imfinzi and Merck’s Keytruda have delivered positive outcomes in their respective neoadjuvant-plus-adjuvant NSCLC trials. If those drugs demonstrate significant benefits over time, Tecentriq’s current adjuvant-only NSCLC use could be in danger.

Still, as Graham noted during the press call, the disease recurrence reduction that perioperative Imfinzi delivered in AZ’s AEGEAN trial didn’t seem very different from Tecentriq’s own performance in the adjuvant setting alone. She noted that it’s uncertain whether Imfinzi’s full benefit has been realized at this point in AZ’s AEGEAN trial.

“What we’re actually going to see in terms of adoption, I think still very much is a question mark,” Graham said.

At an interim analysis of AEGEAN, Imfinzi used before and after surgery posted a 32% reduction in the risk of disease recurrence, progression or death in resectable stage 2 to 3b NSCLC. That result occurred when 35% of patients hadn’t even started their adjuvant treatment.

As for Roche’s own perioperative NSCLC endeavor, Graham said the IMpower030 study will have a much longer duration of treatment when the study reads out in 2024.

“It’s entirely possible that we may see a slightly different results just because our patients will have been on therapy longer,” Graham said, adding that Tecentriq is “still in the game.”