Roche eyes earlier treatment nod after Columvi-chemo trial win in 2nd-line lymphoma

As Genentech bolsters its hematology portfolio with new antibody drugs and bispecifics, the Roche unit has revealed a trial win that could push its recently approved T-cell engager Columvi into earlier lines of treatment.

Genentech’s Columvi—which won its initial U.S. nod back in June—has met the primary overall survival endpoint in the phase 3 STARGLO study testing the drug in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), the company said Monday.

The study paired Columvi, a CD20xCD3 bispecific T-cell engager, with the chemotherapy GemOx (gemcitabine and oxaliplatin) in patients who’d tried at least one prior line of therapy and did not qualify for autologous stem cell transplants.

The Columvi-chemotherapy combo was pitted against Genentech’s fading oncology powerhouse Rituxan in tandem with GemOx.

Columvi was initially approved in June to treat DLBCL or large B-cell lymphoma (LBCL) arising from follicular lymphoma in patients who’ve tried at least two prior lines of systemic therapy. The FDA green light kicked off a rivalry between Columvi and AbbVie and Genmab’s bispecific Epkinly, which won its DLBCL nod just weeks before Genentech’s drug.

Genentech is keeping the specific results from STARGLO close to the vest for now. In its press release, the company simply acknowledged that Columvi and GemOx helped DLBCL patients live longer than those on Roche's own Rituxan. Additionally, the combination’s safety matched up with the known profiles of the individual medicines, Genentech said.

Aside from overall survival, STARGLO also looked at progression-free survival, complete response rates, objective response rates and duration of objective responses, plus safety and tolerability. The company didn't reveal top-line results from the other endpoints.

Still, with positive survival data in hand, Genentech says it plans to submit the results from STARGLO to regulators and present the information at an upcoming medical meeting.

“Building on Columvi’s established benefits, these data demonstrate the potential of this combination regimen to improve survival outcomes in earlier lines of treatment,” Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of global product development, said in a statement.

Genentech’sColumvi win comes a few months after the company in December unveiled a glimpse at early-stage data from the phase 1b NP40126 trial, which showed that Columvi on top of Genentech’s antibody-drug conjugate (ADC) regimen Polivy-R-CHP helped 22 of 24 first-line DLBCL patients achieve a complete response at the end of treatment with no disease progression after a median follow-up of 12 months.

That data drop came three months after Roche kicked off the phase 3 SKYGLO trial testing Columvi and its Polivy-R-CHP regimen in previously untreated DLBCL.

Roche previously faced a blood cancer sales drought as its long-time stalwart Rituxan fell prey to biosimilars and its follow-on Gazyva failed to live up to its blockbuster potential.

But at this year’s J.P. Morgan Healthcare Conference in January, the company said that the rise of hemophilia A blockbuster Hemlibra and ADC Polivy have helped keep the business in good standing, adding that newer T-cell engagers Columvi and Lunsumio would continue to aid in the turnaround.

At the time, the Swiss company estimated sales of its hematology products were on track for a 14% compound annual growth rate through 2026.