Roche is planning to initiate late-stage studies investigating potential combinations for patients with advanced skin cancer based on its immunotherapy Tecentriq, which is already on the market for lung and bladder cancer.
One Phase III trial will test a combination of Tecentriq with EU-approved therapy Cotellic (cobimetinib) plus Zelboraf (vemurafenib) in patients with previously untreated BRAF-mutant metastatic melanoma.
The other will assess an anti-PD-L1 monoclonal antibody with Cotellic in treatment-naïve, BRAF wild-type metastatic melanoma.
The move comes on the back of promising data from Phase Ib studies, announced at the International Congress of the Society for Melanoma Research.
Safety and efficacy results from 30 patients in a Phase Ib study combining Tecentriq with Cotellic, a MEK inhibitor, plus Zelboraf, a BRAF inhibitor, in previously untreated patients with BRAFV600 mutation-positive metastatic melanoma, showed a response rate of 83 percent.
Out of 29 evaluable patients for efficacy, three complete responses and 21 partial responses were observed, and the majority of patients continued to respond at the time of data cut-off (median follow up of 5.6 months). The firm also noted that there were no unexpected adverse events, Grade 5 AEs or Tecentriq-related serious AEs.
Data from a Phase Ib study of Tecentriq with Cotellic showed an objective response rate of 45 percent in 20 patients with non-ocular metastatic melanoma (50 percent in BRAF wild-type and 40 percent in BRAF-mutant patients), and median progression-free survival of 12 months (15.7 months in BRAF wild-type and 11.9 months in BRAF-mutant patients).
On the safety side, grade 3-4 AEs occurred in 59 percent of patients, and no treatment-related Grade 5 AEs were reported. Roche reported.
"We are encouraged by these early results which demonstrate a high proportion of people responded to these investigational combination therapies," said Sandra Horning, MD, Roche's chief medical officer and head of Global Product Development. "The results suggest that the combination of Tecentriq with our BRAF and MEK targeted agents may extend the established benefits of the approved monotherapy and combination approaches of these medicines."