The Antibody Society

the official website of the antibody society

An international non-profit supporting antibody-related research and development.

Columvi® (glofitamab-gxbm) approved by FDA

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On June 15, 2023, the U.S. Food and Drug Administration (FDA) approved Columvi® (glofitamab-gxbm) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response in the Phase 1/2 NP30179 study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Glofitamab (RO7082859, CD20-TCB, RG6026) is a full-length IgG1λ/ҡ bispecific T cell-redirecting antibody targeting CD20 on malignant B cells and CD3 on T cells. This bispecific antibody was developed by Roche using the 2:1 CrossMab technology, characterized by 3 antigen-binding fragment (Fab) arms enabling monovalent binding to CD3ɛ and bivalent binding to CD20, with the second CD20 arm fused to the CD3ɛ-binding arms via a flexible linker. Glofitamab also features a heterodimeric Fc region engineered with PG LALA mutations to abolish binding to FcɣRs and C1q.

The FDA accelerated approval is based on positive results from the Phase 1/2 NP30179 study of Columvi given as a fixed course for 8.5 months in 132 patients with DLBCL who had relapsed or were refractory to prior therapies, including 30% who had received prior CAR T-cell therapy. Additionally, 83% were refractory to their most recent therapy. Results showed patients treated with fixed-duration Columvi achieved durable remission, with 56% of patients achieving an overall response (OR; 74/132 [95% confidence interval (CI): 47-65]) and 43% of patients achieving a complete response (CR; 57/132 [95% CI: 35-52]). Over two-thirds of those who responded continued to respond for at least nine months (68.5% [95% CI: 56.7-80.3]). The median duration of response was 1.5 years (18.4 months [95% CI: 11.4-not estimable]). Data from the NP30179 study were recently published in the New England Journal of Medicine.

Columvi received its first worldwide approval in Canada in March 2023, and the European Medicines Agency’s Committee for Medicinal Products for Human Use recently granted a positive opinion recommending its approval in the European Union.

Glofitamab is under investigation in a randomized, open-label, multicenter Phase 3 study (STARGLO, NCT04408638) where patients with relapsed or refractory DLBCL receive glofitamab or rituximab in combination with gemcitabine + oxaliplatin (GemOx). Patients will receive up to 8 cycles of glofitamab IV or rituximab IV in combination with GemOx IV followed by up to 4 cycles of glofitamab monotherapy. The primary outcome measure is overall survival. The estimated study primary completion date is in April 2025.

Interested in data for other antibody therapeutics that have received marketing authorizations? Go to our searchable table of approved antibody therapeutics and those in regulatory review for more information.

Enter soon – the James S. Huston Antibody Science Talent Award Competition deadline is Sep 15th!

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The Huston Award is given by The Antibody Society to recognize and encourage upcoming scientists in the field of antibody engineering and therapeutics. Early-career research scientists who have received an advanced degree (Ph.D., M.D., or equivalent) within the past 10 years are eligible for the Award. The scientist is recognized for making important contributions to the antibody field and/or the dissemination of antibody knowledge. The recipient will be invited to give a live webinar on their work, which will also be made available on demand on The Antibody Society’s Learning Center and YouTube channel, and to give a lecture at the Antibody Engineering & Therapeutics conference.

The application submission deadline is September 15, 2023.

The Award includes:

  • International recognition of the scientist’s accomplishments,
  • $1500 USD, and
  • Travel expenses and registration fee to attend the Antibody Engineering & Therapeutics conference, to be held December 14-16, 2023 in San Diego, California.

The award criteria and application details are here. Please note: Applicants must be nominated by a Member of the The Antibody Society.

What is it like to win? Our 2022 Huston Award recipient, Prof. Brandon DeKosky, describes his experience in this 2-min video.

On AIRR Podcast Episode 12 Now Available!

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In the latest episode of the On AIRR – An AIRR-C Podcast Series, Dr. Ulrik Stervbo and Dr. Zhaoqing Ding speak with Dr. Charlotte Deane (Professor of Structural Bioinformatics in the Department of Statistics in University of Oxford (UK) and head of the Oxford Protein Informatics Group) about the relevance of including protein structure to study and design antibodies, and the availability of such data. 

You can subscribe and listen in your favorite podcasting app or check out all of the On AIRR episodes here at http://onairr.airr-community.org or on the AIRR YT Channel. If you share podcast-related content in social media, please remember to use the hashtag #onairr!

 

2023 Science Writing Competition winners announced!

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To make science accessible, we need clear and concise communication. The Antibody Society thus offers our student and post-doc members a chance to grow this skill through a Science Writing Competition. This competition is organized and managed by the Society’s Communications & Membership Committee. Entrants submitted essays of 1200 – 1500 words on a topic related to antibody research that were evaluated by our panel of judges.

Our student winner is:

Rodrigo García Valiente, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands

Essay title: Antibodies, those party poopers

Our post-doc winner is:

Dr Zack Saud, Cardiff University, Cardiff, UK

Essay title: On the Origins of Antibodies: Natural and Man-made

Winning essays from previous Science Writing Competitions can be accessed here.

The next Science Writing Competition opens in February 2024.

Thanks to everyone who participated!

FDA approves bispecific antibody EPKINLY™ (epcoritamab-bysp)

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On May 19, 2023, the US Food and Drug Administration approved EPKINLY™ (epcoritamab-bysp) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B‑cell lymphoma, after two or more lines of systemic therapy. Created using Genmab’s DuoBody® technology, epcoritamab (GEN3013, DuoBody®-CD3xCD20) is a T cell-engaging bispecific IgG1k/l antibody targeting CD20 and CD3 that is jointly owned by Genmab and AbbVie. EPKINLY was approved under FDA’s accelerated approval program based on response rate and durability of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial(s).

FDA’s approval was supported by data from the pivotal Phase 1/2 EPCORE NHL-1 trial (NCT03625037) studying epcoritamab in 157 patients with relapsed or refractory large B-cell lymphoma who had received at least two prior systemic therapies, including some who had received prior treatments with CAR-T cell therapy. The dose escalation findings from the Phase 1 part identified a dose of 48 mg as the recommended Phase 2 dose. In the Phase 2 part, patients received 48 mg of epcoritamab as 1 ml subcutaneous injections in 28-day cycles, with weekly dosing in Cycles 1-2, dosing every second week in Cycles 3-6, and dosing every 4 weeks from Cycle 7 onward. An overall response (complete or partial response) was seen in 61% (90/148 [95 percent confidence interval (CI): 52.5-68.7]) of patients and 38% (56/148 [95 percent CI: 30.0-46.2]) achieved complete remission. The median duration of response was 15.6 months (95 percent CI: 9.7-Not reached).

Epcoritamab is being investigated in multiple ongoing clinical studies across different settings and histologies. The most advanced of these is the randomized, open-label Phase 3 EPCORE™DLBCL-1 trial (NCT04628494) of epcoritamab vs investigator’s choice chemotherapy in patients with R/R DLBCL. The study is recruiting an estimated 552 patients and has an estimated primary completion date in June 2024.

Interested in data for other antibody therapeutics that have received marketing authorizations? Go to our searchable table of approved antibody therapeutics and those in regulatory review for more information.