The Swiss pharma giant presented its results Feb. 10 at the 2018 Genitourinary Cancers Symposium in San Francisco.
The IMmotion151 trial (NCT02420821) is comparing the efficacy and safety of Tecentriq and Avastin with the standard treatment Sutent (sunitinib) in patients with inoperable, locally advanced or metastatic renal cell carcinoma (mRCC).
The study enrolled 915 participants who had not received prior systemic or experimental therapy.
Tecentriq and Avastin were given as intravenous doses of 1,200 mg and 15 milligrams per kilogram (mg/kg). Patients received the medications every three weeks. Conversely, participants in the Sutent group received an oral dose of 50 mg, once daily for four weeks followed by a two-week rest. Treatment in both groups continued until no clinical benefit or unacceptable toxicity.
Researchers assessed the primary endpoints, progression-free survival (PFS) in patients with detectable PD-L1 expression — which may allow tumors to evade the body’s immune response — and overall survival in the whole group, until up to 63 weeks of treatment.
Patients receiving Tecentriq plus Avastin had a 26 percent lower risk of disease worsening or death (PFS) than those on Sutent. Conversely, although promising, overall survival results are still preliminary, the company said.
Subgroup analyses indicated that, in patients with detectable tumor PD-L1 expression, treatment with Tecentriq and Avastin delayed disease progression across all risk factor groups (favorable, intermediate and poor).
Safety results of the combination treatment were similar to those of the individual medications, and to the results of the Phase 2 IMmotion150 study (NCT01984242). Furthermore, the rate of treatment-related severe and life-threatening adverse events was lower with the combo approach (40 percent) than with Sutent (54 percent).
Analysis of patient-reported outcomes showed that combining Tecentriq with Avastin significantly delayed the time to worsened disease symptoms that disrupted day-to-day life in the overall study group.
“This is the second positive phase 3 study that includes Tecentriq and Avastin as part of a treatment regimen, providing further evidence to support the potential of this unique combination,” Dr. Sandra Horning, chief medical officer and head of global product development at Roche/Genentech, said in a press release. She added that her company now plans to discuss the results with both the U.S. Food and Drug Administration and the European Medicines Agency.
Tecentriq is an antibody engineered to bind to PD-L1. It is already approved globally to treat certain types of metastatic non-small cell lung cancer and metastatic urothelial cancer. Avastin is the only available renal cell carcinoma treatment that targets vascular endothelial growth factor (VEGF), a protein involved in the formation and maintenance of blood vessels.