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Roche's (RHHBY) Combination Therapy Meets Goal in Lymphoma Study

Roche Holding AG RHHBY announced that the late-stage study evaluating its marketed drug, Columvi (glofitamab), in combination with gemcitabine and oxaliplatin (GemOx), for the treatment of relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) met its primary endpoint of overall survival.

Columvi is Roche’s fixed-duration and CD20xCD3 T-cell engaging bispecific antibody. It is currently approved as a monotherapy by the FDA to treat people with R/R DLBCL after two or more lines of systemic therapy on an accelerated basis. The drug has also received conditional marketing authorization in the EU for the same indication.

The phase III STARGLO study results demonstrated that early-line R/R DLBCL patients, when treated with the Columvi/GemOx combination therapy, lived longer than those treated with MabThera/Rituxan (rituximab) in combination with GemOx.

The study’s secondary endpoints include progression-free survival, complete response rate (CRR), objective response rate and duration of objective response.


Furthermore, Roche also stated that the safety profile of the investigational Columvi/GemOx combination therapy was observed to be consistent with the known safety profiles of the individual medicines.

Per management, there are limited options for DLBCL patients who face relapse or progression after initial treatment, particularly those who are ineligible for autologous stem cell transplant, which represents a high unmet medical need.

Based on positive findings from the STARGLO study, Roche believes that the Columvi/GemOx combination therapy has the potential to improve survival outcomes in earlier lines of treatment.

Year to date, shares of RHHBY have plunged 15.6% against the industry’s 9.4% growth.

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The company’s MabThera/Rituxan is currently approved in the United States and several other countries to treat non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia and rheumatoid arthritis.

Please note that DLBCL is the most common form of NHL and is aggressive (fast-growing) in nature. DLBCL accounts for approximately one-third of all NHL cases.

NHL is a type of B-cell malignancy that begins in damaged B cells and affects the lymphatic system, which is part of the immune system, causing painless swollen lymph nodes in the neck, chest pain, abdominal pain, tiredness, night sweats, weight loss and fever.

Roche Holding AG Price and Consensus

Roche Holding AG Price and Consensus
Roche Holding AG Price and Consensus

Roche Holding AG price-consensus-chart | Roche Holding AG Quote

Several companies in the medical sector, including Nurix Therapeutics, Inc. NRIX and ALX Oncology Holdings Inc. ALXO, are currently developing distinguished candidates to treat B-cell malignancy indications.

Last week, Nurix presented initial findings of clinical responses in the brain for its investigational targeted protein degrader, NX-5948, from the dose escalation stage of its ongoing phase Ia/Ib study in patients with relapsed or refractory B-cell malignancies.

NRIX’s NX-5948 is an orally available and selective degrader of Bruton’s tyrosine kinase.

Nurix presented new case studies for two patients, one with chronic lymphocytic leukemia and the other with primary central nervous system lymphoma, each with central nervous systeminvolvement. Initial findings demonstrated the therapeutic effect of NX-5948 in the brain, observing clinically meaningful responses in both patients.

ALXO also shared positive results from an ongoing phase I/II investigator-sponsored study of evorpacept, in combination with Rituxan and Bristol Myers’ BMY Revlimid (lenalidomide) (R2), to treat indolent and aggressive R/R B-cell NHL.

ALX Oncology announced that patients receiving evorpacept, in combination with standard R2 treatment, achieved a promising initial activity with a best overall response rate (ORR) of 94% and a CRR of 83% in patients with indolent R/R B-NHL.

The results are even better than that observed with only R2 treatment, reporting an ORR of 78% and a CRR of 34% in the benchmark phase III AUGMENT clinical study, which was conducted in a similar patient population.

Per ALX Oncology, such positive initial results reaffirm the therapeutic benefit of evorpacept’s novel mechanism of action that results in anti-cancer activity while minimizing hematologic toxicities inherent to other CD47 blocking agents.

Bristol Myers’ Revlimid is currently approved across different countries for several oncology indications, including multiple myeloma, myelodysplastic syndrome and NHL.

However, Bristol Myers’ Revlimid is facing generic competition, which affected its sales in 2023.

Zacks Rank

Roche currently carries a Zacks Rank #4 (Sell).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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