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Tisotumab vedotin approved by FDA for cervical cancer

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On September 20, 2021, FDA granted accelerated approval to TIVDAK (tisotumab vedotin-tftv) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The BLA for TIVDAK for this indication was given a Priority review. TIVDAK’s approval was based on tumor response and the durability of the response; verification and description of clinical benefit in confirmatory trials may be necessary for continued approval for this indication.

TIVDAK is an ADC comprising Genmab’s human tissue factor IgG1k antibody targeting tissue factor conjugated to MMAE via a protease-cleavable linker using Seagen’s ADC technology. The companies are co-developing the product. The recommended dose of TIVDAK is 2 mg/kg (up to a maximum of 200 mg) given as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.

FDA’s approval was based on results of the pivotal single-arm Phase 2 innovaTV 204 study (NCT03438396), which included 101 patients with recurrent or metastatic cervical cancer who had received no more than two prior systemic regimens in the recurrent or metastatic setting, including at least one prior platinum-based chemotherapy regimen. Patients received tisotumab vedotin 2.0 mg/kg IV every 3 weeks  until progression or toxicity. The major efficacy outcome measures were confirmed objective response rate as assessed by an independent review committee using RECIST v1.1 criteria and duration of response (DOR). The objective response rate was 24% [95% CI: 15.9%-33.3%], including 7 patients (7%) with a complete response and 17 patients (17%) with a partial response, and the median DOR was 8.3 months (95% CI: 4.2, not reached).

TIVDAK is the 9th antibody therapeutic to be first approved for marketing in the EU or US in 2021. Explore our searchable table of antibody therapeutics approved in the US or EU for details.

FDA approves ansuvimab-zykl for Ebola virus infection

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On December 21, 2020, the US Food and Drug Administration approved Ebanga (ansuvimab-zykl) for the treatment for Zaire ebolavirus (Ebolavirus) infection in adults and children. Ebanga had been granted US Orphan Drug designation and Breakthrough Therapy designations. Ansuvimab is a human IgG1 monoclonal antibody that binds and neutralizes the virus.

The safety and efficacy of Ebanga were evaluated in the multi-center, open-label, randomized controlled PALM trial. In this study, 174 participants (120 adults and 54 pediatric patients) with confirmed Ebolavirus infection received Ebanga intravenously as a single 50 mg/kg infusion and 168 participants (135 adults and 33 pediatric patients) received an investigational control. The primary efficacy endpoint was 28-day mortality. Of the 174 patients who received Ebanga, 35.1% died after 28 days, compared to 49.4% of the 168 patients who received a control.

Ebanga is the 12th antibody therapeutic to be granted a first approval in the US or EU during 2020.

The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US. The table, which is located in the Web Resources section of the Society’s website, can be downloaded in Excel format.

FDA approves MARGENZA™

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On December 16, 2020, the US Food and Drug Administration approved margetuximab-cmkb (MARGENZA), in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. MARGENZA is a chimeric IgG1 monoclonal antibody that binds to HER2. The antibody’s modified Fc region increases binding to the activating Fc receptor CD16A and decreases binding to the inhibitory Fc receptor CD32B,  which leads to greater in vitro antibody-dependent cell-mediated cytotoxicity and natural killer cell activation.

FDA’s approval was based on safety and efficacy results from the pivotal Phase 3 SOPHIA trial, which showed a statistically significant 24% reduction in the risk of disease progression or death with MARGENZA plus chemotherapy compared with trastuzumab plus chemotherapy (hazard ratio [HR]=0.76; 95% CI, 0.59-0.98; P=0.033; median PFS 5.8 vs 4.9 months). The objective response rate  for MARGENZA plus chemotherapy was 22% vs 16% for trastuzumab plus chemotherapy.

MARGENZA is the 11th antibody therapeutic to be granted a first approval in the US or EU during 2020.

The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US. The table, which is located in the Web Resources section of the Society’s website, can be downloaded in Excel format.

FDA approves Inmazeb for Ebola virus infection

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On October 14, 2020, FDA approved the triple antibody cocktail of atoltivimab, maftivimab, and odesivimab-ebgn (Inmazeb) for the treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients. Atoltivimab, maftivimab, and odesivimab are IgG1 antibodies that bind glycoprotein on the surface of Ebola virus, thereby blocking attachment and entry of the virus into cells. FDA granted the atoltivimab, maftivimab, and odesivimab cocktail Breakthrough Therapy and Orphan Drug designations for the approved indication. Inmazeb was developed by Regeneron.

The effects of Inmazeb were evaluated in adult and pediatric patients with confirmed infections that occurred during an Ebola virus outbreak in the Democratic Republic of the Congo in 2018 and 2019. In the Pamoja Tulinde Maisha (PALM) study (NCT03719586), a 4-arm trial evaluating investigational therapies for Ebola virus infection initiated in November 2018, 154 patients received Inmazeb  as a single IV infusion of 50 mg of each monoclonal antibody. The primary efficacy endpoint was 28-day mortality. At this timepoint, 33% of those who received Inmazeb had died vs 51% of those who received a control. Inmazeb was also made available in an expanded access program, which included an additional 228 patients who received Inmazeb. The PALM study was sponsored by the US National Institute of Allergy and Infectious Diseases, with collaborators from Institut National de Recherche Biomédicale (Democratic Republic of Congo); the Alliance for International Medical Action (Senegal); International Medical Corps, Los Angeles (US); Epicentre, Médecins sans Frontières, (France); and the World Health Organization (Switzerland).

Inmazeb is the 9th antibody therapeutic to be granted a first approval in the US or EU in 2020.

The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US. The table, which is located in the Web Resources section of the Society’s website, can be downloaded in Excel format.

Antibodies to Watch in a Pandemic

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The extraordinary scale of the COVID-19 pandemic has elicited extraordinary responses world-wide, but the resulting disruptions have raised concerns about delays in approval of non-COVID-19 antibody therapeutics.

As part of the virtual Antibody Engineering & Therapeutics Europe conference, Dr. Janice Reichert, Executive Director of The Antibody Society,  provided an update on non-COVID-19 antibody therapeutics approved so far in 2020, and those that might be approved by the end of the year. She also discussed the biologics currently in development for COVID-19, which includes over 50 repurposed biologics and over 80 anti-SARS-CoV-2 biologics.

Broadcast date: Thursday August 27, 2020.

Updated presentation slides can be downloaded here.

Dataset of commercially sponsored biologic COVID-19 interventions can be downloaded here.