Follicular Lymphoma Preview Content

Abstract Number – 7524

Genmab and Abbvie to present the efficacy and safety data of epcoritamab. What about the antibody’s market positioning in FL?

EPCORE NHL-2 is a Phase Ib/II trial evaluating the safety and preliminary efficacy of epcoritamab in combination with other agents in R/R FL.

Epcoritamab is an investigational IgG1--bispecific antibody created using Genmab’s proprietary DuoBody technology, which is currently being evaluated as a treatment option for patients with FL in several clinical trials. In March 2022, Genmab announced the US FDA grant of Orphan Drug Designation to epcoritamab for the treatment of FL.

On the other hand, in April 2022, Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended approval under conditional marketing authorization of mosunetuzumab in R/R FL patients who have received at least two prior systemic therapies. Based on this positive CHMP opinion, a final decision regarding the conditional approval of mosunetuzumab is expected from the European Commission soon.

In June 2020, mosunetuzumab was granted Breakthrough Therapy Designation by the US FDA 2L+ FL patients. The CHMP recommendation was based on positive results from the Phase I/II study, where mosunetuzumab showed high complete response (CR) rates, with most complete responders maintaining responses for at least 18 months and favorable tolerability in people with heavily pretreated FL. In addition to that, after a median follow-up of 18.3 months, the CR rate was 60% (n = 54/90), the objective response rate was 80% (n = 72/90), and the median progression-free survival was 17.9 months. The median duration of response among those who responded was 22.8 months. Therefore, we are inquisitive about the presentation concerning these bispecific antibodies on June 4, 2022, at the ASCO 2022 Conference via Poster Session.

Abstract Number – 7510

Beigene’s BTK inhibitor in patients with high-risk follicular lymphoma population.

 ROSEWOOD is a global Phase II trial evaluating the efficacy, safety, and tolerability of BGB-3111 (zanubrutinib) plus obinutuzumab versus obinutuzumab alone in participants with R/R non-Hodgkin’s follicular lymphoma.

One of Beigene’s leading products, Brukinsa, is a Bruton’s tyrosine kinase (BTK) inhibitor, which is currently being evaluated globally in various B-cell malignancies. The company already has approved drugs in Latin America for mantle cell lymphoma, marginal zone lymphoma, and Waldenström’s macroglobulinemia. Additionally, the company is diversifying its scope to other indications as well. One of the major competitors for Brukinsa in the BTK inhibitor class is Imbruvica (Ibrutinib).

We look forward to the encouraging data from the ROSEWOOD trial in FL on June 5, 2022, at the ASCO 2022 Conference via Poster Discussion Session.

Conclusion

There is no standard treatment or sequence of treatments for R/R FL. So the expected outcomes of the bispecific antibodies could be an enhancer in terms of treatment patterns for the patients who have follicular lymphoma. As the majority of people with follicular lymphoma experience frequent relapses, and with each successive therapy, the duration of remission and survival shortens. In hematologic malignancies, this can bring new hope for treatment options to the people living with this disease. However, the rivalry of epcoritamab has stirred interest, considering that mosunetuzumab will have a first-mover advantage as the company has completed the filing process in Europe and CHMP has already validated their MAA application. Therefore, we look forward to the encouraging data from these bispecific antibodies in FL.

Mosunetuzumab if approved, would be the first CD20xCD3 T-cell engaging bispecific antibody available to treat FL offering a new, off-the-shelf, fixed-duration treatment option. In addition, BTK inhibitors are promising novel agents that have potential efficiency in B-cell malignancies, but in some indications like DLBCL, FL, and MM, the response rates were slightly lower in the patients. However, we anticipated that the primary analysis of the ROSEWOOD trial could unearth valuable insights and open new horizons for better treatment options for patients who have follicular lymphoma.

Moreover, CAR-T cell therapies are more beneficial in DLBCL, FL, and other indications of hematologic malignancies. It can be substantiated by the recent FDA and EC approval of Novartis’ Kymriah as the first CAR-T cell therapy for adults with R/R FL. In a nutshell, we believe that bispecific and monoclonal antibodies will face stiff competition from CAR-T cell therapies.

The rest of the key abstracts have been summarized in the table below: