ESMO: Seagen and Genmab's Tivdak keeps cervical cancer patients alive longer

On the verge of a $43 billion powerhouse merger with Pfizer, Seagen has two Presidential Symposium presentations at the European Society of Medical Oncology (ESMO) Congress in Madrid, further evidence of the influence antibody-drug conjugates are wielding in the cancer arena.

“We’re fortunate to have two presidential presentations at the same time,” Seagen R&D chief Roger Dansey, M.D., said in an interview with Fierce Pharma. “It’s a validation of all we’ve been trying to do—trying to make a difference in patients’ lives.”

In addition to a high-profile presentation on the combination of Seagen and Astellas’ Padcev with Merck’s Keytruda in bladder cancer, the company is joining with Genmab of Denmark to tout the potential of Tivdak to treat cervical cancer.

Last month, the companies said they had scored a victory over chemotherapy in the innovaTV 301 trial, showing that Tivdak could extend the lives of patients who had recurrent or metastatic cervical cancer, with disease progression on or after first-line therapy.

At ESMO, investigators unveiled the detailed data, which included a 30% reduction in the risk of death. Tivdak also demonstrated a 33% reduction in the risk of disease progression and an objective response rate of 17.8% versus 5.2% for the chemotherapy arm, with all of the complete responses occurring in the Tivdak group.

As for the disease control rate, 75.9% of Tivdak patients had a complete response, a partial response or saw their disease remain stable, while 58.2% of those on chemo achieved the same.  

“We’ve got a medicine that we can bring forward that will extend the lives of these patients where there’s a high unmet need,” Dansey said. “And the promise of Tivdak doesn’t stop with previously treated patients. We have the potential to move into earlier lines of cervical cancer. We’re thinking about generating data to see if that’s possible.”

That’s something Merck’s cancer juggernaut Keytruda has already accomplished, hoping to secure an approval to treat all first-line patients. In 2021, Keytruda was endorsed for cervical cancer patients but only those whose tumors express a PD-L1 biomarker at a combined positive score of at least 1.

As for Tivdak, Dansey added that Seagen also is seeing “some pretty interesting results” with the ADC in head and neck cancer.

The FDA signed off on Tivdak on a conditional basis in 2021 for patients whose disease had progressed during or after chemotherapy. Serving as a confirmatory trial, the innovaTV 301 results could pave the way for a full nod. Since its approval, guidelines from the National Comprehensive Cancer Network have specified Tivdak a preferred second-line treatment.

The need for new treatments in cervical cancer is high. It is estimated that there will be more than 13,960 new cases diagnosed in the U.S. with approximately 4,310 deaths, Seagen said. One of the more devastating aspects of cervical cancer is its tendency to strike younger women.  

“The average age of these patients, these women, is 50, not 70,” Dansey said. “They are a young population with obviously a lot of life ahead of them if we can give it to them.”