Dive Brief:
- Roche's new immunotherapy Tecentriq (atezolizumab) helped shrink tumors in 24% of previously-untreated patients with advanced bladder cancer who were ineligible for standard chemotherapy treatment, the company said Sunday.
- Tecentriq was approved by the FDA last month for second-line treatment of advanced bladder cancer, making it the first new therapy for the disease in about 30 years.
- Median overall survival was 14.8 months following treatment with Tecentriq and 7% of patients (n=8) saw a complete response.
Dive Insight:
Tecentriq is also the first PD-L1 therapy to be approved in the U.S. Its efficacy in advanced bladder cancer patients -- many of whom are not eligible for treatment with standard cisplatin chemotherapy -- has sparked interest from the oncology community because of evidence of sustained tumor shrinkage in patients with metastatic disease, including those whose disease had spread to the liver and bones.
On average, cisplatin-ineligible patients with advanced disease live nine to 10 months. Among patients with this profile who received Tecentriq, 75% who responded to therapy were still alive 14.4 months later.
Tecentriq can be less toxic than standard chemotherapy. Only 6% of patients in trials discontinued due to side effects, but dosing was interrupted due to adverse events in 35% of patients.
“These Tecentriq results are highly encouraging because about half of all people with this type of bladder cancer are not able to tolerate a cisplatin-based chemotherapy, and alternative treatments bring very limited duration of response," said Dr. Sandra Horning, chief medical officer and head of global product development at Roche.
For the phase 2 study, patients were enrolled in one of two cohorts, depending on treatment histories. Cohort one involved patients who had not received previous treatment for their bladder cancer, and the results could help Roche build a case for Tecentriq as a first-line treatment.
With Tecentriq's approval last month, Roche joined Bristol-Myers Squibb and Merck in the anti-PD1/PDL1 market. Bristol-Myers' Opdivo has quickly carved out a lead in treating lung and skin cancer but all three companies have ambitious plans to broaden their respective drugs' indications.