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European Commission approves Lunsumio for people with relapsed or refractory follicular lymphoma

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On June 8, 2022, Roche announced that the European Commission granted conditional marketing authorization for Lunsumio® (mosunetuzumab), a T-cell engaging bispecific antibody that targets CD20 and CD3, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies. Mosunetuzumab (RG7828, BTCT4465A) is an aglycosylated (N297G) humanized IgG1k bispecific antibody constructed using knobs-into-holes technology.

The approval is based on positive results from the Phase I/II GO29781 study (NCT02500407) in which Lunsumio demonstrated high complete response rates, with the majority of complete responders maintaining responses for at least 18 months, and favorable tolerability in people with heavily pre-treated FL. After a median follow-up of 18.3 months, the median duration of response among responders was 22.8 months (95% CI: 9.7-not estimable), the complete response rate was 60% (n=54/90), the objective response rate was 80% (n=72/90). Lunsumio is currently being evaluated in two Phase 3 studies: CELESTIMO, investigating Lunsumio plus lenalidomide in second line plus (2L+) FL, and SUNMO, investigating Lunsumio plus Polivy® (polatuzumab vedotin) in 2L+ diffuse large B-cell lymphoma.

FDA approves Enjaymo (sutimlimab-jome) for cold agglutinin disease

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On February 4, 2022, the US Food and Drug Administration (FDA) approved Enjaymo (sutimlimab-jome) infusion to decrease the need for red blood cell transfusion due to hemolysis in adults with cold agglutinin disease (CAD). This rare autoimmune disorder is characterized by hemolysis caused by activation of the classic complement pathway. Sponsored by Sanofi, sutimlimab is a hinge-stabilized, humanized IgG4k antibody that targets and inhibits complement component 1s (C1s). A mutation in the Fc region (L235E) reduces the effector functions of the antibody. Sutimlimab received FDA’s Breakthrough Therapy and Orphan Drug designations for CAD, and Orphan Drug designation in the EU for this indication.

The BLA was based on data from the CARDINAL open-label, single-arm study (NCT03347396), which enrolled 24 adult patients with CAD who received a recent blood transfusion. All participants received Enjaymo for up to six months and could choose to continue therapy in a second part of the trial. Based on body weight, participants received either a 6.5 g or 7.5 g infusion of Enjaymo on day 0, day 7, and every 14 days through week 25. In total, 54% of participants responded to Enjaymo. In this study, sutimlimab administration rapidly halted hemolysis, increased hemoglobin levels, and reduced fatigue.

The European Medicines Agency has accepted the submission of a Marketing Authorisation Application for sutimlimab.

Enjaymo is the 3rd antibody-based therapeutic granted a first approval for marketing in the EU or US in 2022. Explore our searchable table of antibody therapeutics approved in the EU or US for details.

FDA approves KIMMTRAK® (tebentafusp-tebn) for unresectable or metastatic uveal melanoma

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On January 26, 2022, Immunocore Holdings plc announced the approval from the United States Food and Drug Administration (FDA) of KIMMTRAK® (tebentafusp-tebn) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM). Tebentafusp (IMCgp100) is a bispecific fusion protein composed of: 1) a T cell receptor (TCR) recognizing a human leukocyte antigen (HLA)-A*02:01 complexed with a peptide derived from gp100 antigen expressed by melanoma cells, and 2) an antibody single-chain variable fragment that binds CD3 present on T cells. Developed by Immunocore, this molecule creates a bridge between tumor cells and immune cells, and thus facilitates tumor-cell killing by T cells. As the TCR domain recognizes a peptide presented on HLA-A*02:01, tebentafusp can only be used to treated patients expressing this HLA type. Tebentafusp has been granted Breakthrough Therapy, Fast Track, and Orphan Drug designations by the FDA.

The marketing applications are based on a late-stage clinical trial (NCT03070392) that enrolled 378 patients with advanced uveal melanoma who were HLA-A*0201–positive. In the study, patients were randomized 2:1 to receive tebentafusp or investigator’s choice of therapy (either pembrolizumab, ipilimumab, or dacarbazine). Tebentafusp was administered at a dose of 20 micrograms on cycle 1 Day 1, then 30 micrograms on cycle 1 Day 8, then 68 micrograms on cycle 1 Day 15 and weekly thereafter by IV infusion over 15 minutes until confirmed disease progression or unacceptable toxicity. The primary outcome measure is overall survival. As reported in September 2021, the OS Hazard Ratio in the intent-to-treat population favored KIMMTRAK, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine). Moreover, the 1-year survival rate was 73% for patients in the experimental arm vs. 59% in the investigator’s choice arm.

The European Medicines Agency, the United Kingdom’s Medicines and Healthcare Regulatory Agency, Health Canada, and the Australian Government Department of Health Therapeutic Goods Administration have accepted the submission of Marketing Authorisation Applications for tebentafusp.

KIMMTRAK is the 1st antibody-based therapeutic granted a first approval for marketing in the EU or US in 2022. Explore our searchable table of antibody therapeutics approved in the EU or US for details.

FDA approves Solensia (frunevetmab) for osteoarthritis pain in cats

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On January 13, 2022, the U.S. Food and Drug Administration (FDA) approved Solensia (frunevetmab), the first monoclonal antibody (mAb) new animal drug approved by the FDA for use in any animal species. Solensia™ is approved for the control of pain associated with osteoarthritis in cats.

Developed by Zoetis Inc., frunevetmab is a felinized immunoglobulin G mAb that targets nerve growth factor. Similar to humanization, felinization is a process in which all regions of a murine antibody are replaced with feline counterparts except for the complementarity-determining regions. Substantial evidence of effectiveness was demonstrated by the results of two field studies in cats with naturally occurring osteoarthritis. The endpoints used to evaluate the effectiveness of Solensia™ were observer-reported measures conducted by either owners (assessment of the cat’s activities before development of osteoarthritis, as well as before and after treatment) or veterinarians (orthopedic examinations before and after treatment).

Solensia™ is given by subcutaneous injection once a month and is dosed by weight range. Cats are given the full contents of 1 or 2 vials based on body weight to target a minimum dose of 1 mg/kg. Each vial contains 7 mg of frunevetmab.

At least one other mAb, lokivetmab (Cytopoint), is approved for veterinarian use in the US.  Manufactured by Zoetis, the product is used to treat atopic dermatitis in dogs, but it was approved by the US Department of Agriculture, not FDA. More information on FDA’s Center for Veterinary Medicine and the New Animal Drug Application (NADA) process can be found here.

FDA approves 10 antibody-based therapeutics in 2021

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The US Food and Drug Administration approved a total of 10 novel antibody-based therapeutics in 2021. Of the newly approved products, 4 are treatments for cancer (endometrial, non-small cell lung, and cervical cancers, as well as B-cell lymphoma) and 6 are treatments for non-cancer indications (hypercholesterolemia, Alzheimer’s disease, systemic lupus erythematousus, asthma, generalized myasthenia gravis, and atopic dermatitis).

The products are:

  • Evkeeza (evinacumab-dgnb) approved 2/11/2021 to treat homozygous familial hypercholesterolemia
  • Jemperli (dostarlimab-gxly) approved 4/22/2021 to treat endometrial cancer
  • Zynlonta (loncastuximab tesirine-lpyl) approved 4/23/2021 to treat certain types of relapsed or refractory large B-cell lymphoma
  • Rybrevant (amivantamab-vmjw) approved 5/21/2021 to treat a subset of non-small cell lung cancer
  • Aduhelm (aducanumab-avwa) approved 6/7/2021 to treat Alzheimer’s disease
  • Saphnelo (anifrolumab-fnia) approved 7/30/2021 to treat moderate-to severe systemic lupus erythematousus along with standard therapy
  • Tivdak (tisotumab vedotin-tftv) approved 9/20/2021 to treat recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
  • Tezspire (tezepelumab-ekko) approved 12/17/2021 to treat severe asthma as an add-on maintenance therapy
  • Vyvgart (efgartigimod alfa-fcab) approved 12/17/2021 to treat generalized myasthenia gravis
  • Adbry (tralokinumab-ldrm), approved 12/27/2021 to treat moderate-to-severe atopic dermatitis

Links to further information for these products, including approval letters and labels, can be found here.

Wondering what might be approved in 2022? The Antibody Society maintains a table of antibody therapeutics in regulatory review in the US or European Union. The table can be found here.