Glofitamab Plus Chemo Improves Survival vs Rituximab in R/R DLBCL

Glofitamab (Columvi) plus chemotherapy improved overall survival (OS) compared with rituximab (Rituxan) and chemotherapy in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who received at least 1 prior line of therapy and were ineligible for autologous stem cell transplant (ASCT), meeting the primary end point of the phase 3 STARGLO trial (NCT04408638).¹

Complete data from STARGLO will be presented at an upcoming medical meeting and submitted to regulatory authorities.

“People with this aggressive lymphoma facing relapse or progression after initial treatment have limited options—particularly those who are ineligible for stem cell transplant,” said Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche, in a press release. “Building on [glofitamab’s] established benefits, these data demonstrate the potential of this combination regimen to improve survival outcomes in earlier lines of treatment.”

STARGLO compared glofitamab plus gemcitabine and oxaliplatin (GemOx) vs rituximab plus GemOx. The safety profile of the glofitamab and GemOx appeared consistent with the known profiles of the individual agents.

Glofitamab was the first fixed-duration bispecific antibody to be granted FDA accelerated approval and conditional marketing authorization from the European Commission in patients with R/R DLBCL who had received 2 or more prior lines of therapy. These approvals were based on findings from the phase 1/2 NP30179 study (NCT03075696) evaluating glofitamab as a monotherapy.

About the Phase 3 STARGLO Study

STARGLO has an estimated enrollment of 270 patients across 13 countries.² The primary end point is OS, and secondary end points include progression-free survival (PFS), complete response (CR) rate, objective response rate (ORR), duration of response (DOR), duration of CR, incidence of adverse events, and tolerability.

Patients were randomized to receive up to 8 cycles of glofitamab plus GemOx followed by up to 4 cycles of glofitamab monotherapy or up to 8 cycles of rituximab plus GemOx.

Patients with histologically confirmed DLBCL who had received at least 1 line of prior therapy, were not candidates for high-dose chemotherapy followed by ASCT, had an ECOG performance status of 0 to 2, and had adequate hematologic and renal function were eligible for enrollment.

About the Phase 1/2 NP30179 Study

NP30179 is a dose-escalation and dose-expansion study of glofitamab as a single agent and in combination with obinutuzumab (Gazvya) in patients with R/R B-cell non-Hodgkin lymphoma.³ The study has an estimated enrollment of 860 patients across 13 countries.

The study’s primary end points include dose-limiting toxicities, incidence of adverse events, maximum tolerated dose, recommended phase 2 dose, CR rate, and pharmacokinetics. Secondary end points include ORR, DOR, duration of CR, PFS, OS, time to first overall response, and time to first CR.

Patients with an ECOG performance status of 0 or 1, adequate laboratory function, a life expectancy of at least 12 weeks, and resolved adverse events from prior therapies are eligible for participation in the study.

REFERENCES:

1. Roche’s Columvi meets primary endpoint of overall survival in people iwth relapsed or refractory diffuse large B-cell lymphoma in phase III STARGLO study. News release. Roche. April 15, 2024. Accessed April 15, 2024. https://tinyurl.com/3pyt29hm

2. A phase III study evaluating glofitamab in combination with gemcitabine + oxaliplatin vs rituximab in combination with gemcitabine + oxaliplatin in participants with relapsed/refractory diffuse large B-cell lymphoma. ClinicalTrials.gov. Updated April 8, 2024. Accessed April 15, 2024. https://www.clinicaltrials.gov/study/NCT04408638

3. A dose escalation study of glofitamab (RO7082859) as a single agent and in combination with obinutuzumab, administered as a fixed, signle pre-treatment dose of obinutuzumab in participants with relapsed/refractory B-cello non-Hodgkin's lymphoma. ClinicalTrials.gov. Updated March 22, 2024. Accessed April 15, 2024. https://clinicaltrials.gov/study/NCT03075696