AbbVie continues the ADC party and beefs up its anti-solid tumor portfolio with the acquisition of ImmunoGen for $10.1B. ImmuoGen’s flagship cancer therapy is Elahere (mirvetuximab soravtansine-gynx), a first-in-class antibody-drug conjugate (ADC) approved for platinum-resistant ovarian cancer (PROC), according to an announcement yesterday.
This has been the year of the ADC—agents that link cytotoxic drugs to monoclonal antibodies (mAbs) to be delivered to tumor tissue that express particular antigens.
The field is estimated to be worth about $6B already. Pfizer, BioNTech, Merck, and BMS all made major ADC deals this year. Pfizer’s was the biggest move, as the company shelled out $43B for Seagen, formerly Seattle Genetics. Four of the twelve total FDA-approved and marketed ADCs use Seagen’s technology. Daiichi Sankyo is another ADC leader.
“The acquisition of ImmunoGen demonstrates our commitment to deliver on our long-term growth strategy and enables AbbVie to further diversify our oncology pipeline across solid tumors and hematologic malignancies,” said Richard A. Gonzalez, chairman and chief executive officer, AbbVie.
Ovarian cancer is the leading cause of death from gynecological cancers in the U.S. and Elahere is the first targeted medicine to show meaningful survival benefit in PROC. The drug is expected to net $500M next year and to see substantial growth after that. It provides AbbVie with a potential multi-billion-dollar asset with expansion opportunities in earlier lines of therapy and larger segments of the ovarian cancer market.
“With global commercial infrastructure and deep clinical and regulatory expertise, AbbVie is the right company to accelerate geographic and label expansion, and realize the full potential of Elahere as the first and only ADC approved in ovarian cancer,” said Mark Enyedy, president and chief executive officer, ImmunoGen.
“The addition of ImmunoGen’s pipeline, platform, and expertise to AbbVie’s oncology portfolio is an exciting opportunity for the combined companies to advance innovation in ADCs. This transaction is the culmination of our 40-year commitment to develop and deliver the next-generation of ADCs and more good days for people living with cancer.”
Elahere is a first-in-class ADC targeting folate receptor alpha (FRα) with a maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells. The drug received U.S. Food and Drug Administration (FDA) accelerated approval in 2022 for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.
Positive Phase III results from the MIRASOL confirmatory trial will support a Marketing Authorization Application (MAA) to the European Union and a supplemental iologic License Application (sBLA) submission to the U.S. FDA in order to gain full approval. Ongoing clinical development programs are underway to expand into earlier lines of therapy and enter other large patient segments of the ovarian market over the next five to ten years.
ImmunoGen’s follow-on pipeline of next-generation ADCs should expand AbbVie’s growing oncology pipeline of potentially transformative programs across multiple different solid tumors and hematologic malignancies. ImmunoGen’s Phase I asset, IMGN-151, is a next-generation anti-FRα ADC for ovarian cancer with the potential for expansion into other solid tumor indications. Pivekimab sunirine, currently in Phase II, is an anti-CD123 ADC targeting blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare blood cancer, which was granted FDA breakthrough therapy designation for the treatment of relapsed/refractory BPDCN.
