Benzinga - by Vandana Singh, Benzinga Editor.
Monday, Roche Holdings AG (OTC:RHHBY) announced topline data from Phase 3 STARGLO study of Columvi (glofitamab) in combination with gemcitabine plus oxaliplatin (GemOx) versus MabThera/Rituxan (rituximab) in combination with GemOx in certain subset of patients with diffuse large B-cell lymphoma.
The Phase 3 STARGLO study met its primary endpoint of overall survival.
The study demonstrated that people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant, lived longer when treated with Columvi (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) versus MabThera/Rituxan (rituximab) in combination with GemOx.
The safety of the combination appeared consistent with the known safety profiles of the individual medicines.
Columvi was the first fixed-duration bispecific antibody to receive FDA accelerated approval and conditional marketing authorization from the European Commission to treat people with R/R DLBCL after two or more lines of systemic therapy.
Approvals were based on the results of Columvi as a monotherapy from the pivotal Phase 1/2 NP30179 study in patients with R/R DLBCL who had previously received two or more prior treatments.
Earlier this year, Roche terminated two cancer drug deals.
- In February, Repare Therapeutics Inc (NASDAQ:RPTX) regained global development and commercialization rights to camonsertib (RP-3500) following the termination of its collaboration agreement with Roche.
- In January, Roche decided to terminate the collaboration and licensing agreement for HOOKIPA Pharma Inc's (NASDAQ:HOOK) HB-700 program in KRAS mutated cancers. Effective April 25, 2024, HOOKIPA will regain full control.
Price Action: RHHBY shares closed at $30.59 on Friday.
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