- Roche has withdrawn an application to the European Medicines Agency that sought an expanded approval for its immunotherapy Tecentriq in advanced kidney cancer, concluding in a letter to the regulator data were insufficient to support a label extension.
- The Swiss drugmaker had submitted its application based on results from the IMmotion 151 study, which paired Tecentriq with Avastin in previously untreated patients with unresectable locally advanced or metastatic renal cell carcinoma (RCC).
- The European Medicines Agency was still evaluating the pharma's initial documentation when Roche notified the regulator of its decision, which it said doesn't impact any ongoing clinical trials of Tecentriq as a monotherapy or in combination with other drugs.
Roche has changed its tune from February, when the drugmaker said it was "encouraged" by initial data from IMmotion 151.
Those results showed Tecentriq (atezolizumab) plus Avastin (bevacizumab) reduced the risk of disease worsening or death by 26% compared to Pfizer's Sutent (sunitinib) in kidney cancer patients with high levels of the PD-L1 biomarker.
At the time, data on overall survival (OS) — the study's other co-primary endpoint — were described as positive, but "immature." In its letter to the EMA, Roche noted IMmotion 151 would continue per protocol to the next analysis for OS.
That Roche pulled its application suggests the company doesn't believe its current case, with results only on progression-free survival, will be enough for an approval.
Perhaps affecting its decision-making are emerging datasets from competitors with supportive OS data.
Merck & Co.'s checkpoint inhibitor Keytruda (pembrolizumab), when paired with Pfizer's Inlyta (axitinib), extended survival versus Sutent in first-line RCC, recent results showed. Pfizer has also paired Inlyta with its and Merck KGaA's own immunotherapy Bavencio (avelumab) in first-line RCC, reading out positive progression-free survival results in September.
And in Europe, regulators last week recommended extending approval for Bristol-Myers Squibb's Opdivo (nivolumab) to include first-line use in combination with Yervoy (ipilimumab) for adult RCC patients with intermediate- or poor-risk disease.
On a more positive note for Roche — the Food and Drug Administration recently granted priority review to Tecentriq in combination with Abraxane (nab-paclitaxel) for initial treatment of people with PD-L1-positive, metastatic triple-negative breast cancer. This would be the first cancer immunotherapy regimen for this particular patient group.
In the important lung cancer market, however, Roche faces a three-month delay in the U.S. on its application for approval of Tecentriq and Avastin in previously untreated patients with metastatic disease.