- The Food and Drug Administration has approved Seagen and Genmab's drug Tivdak for patients with cervical cancer whose tumors have relapsed or spread after chemotherapy. Tivdak is the first of its kind to target a protein called tissue factor that's frequently expressed on cancerous cells.
- Tivdak's approval is the fourth for both Seagen and Genmab, the latter of which has launched other products in partnership with Johnson & Johnson, Novartis and Roche. Tivdak, a type of medicine called an "antibody-drug conjugate," is composed of a protein-targeting antibody owned by Genmab and Seagen technology that links a tumor-killing chemical.
- Tivdak won accelerated clearance based on study results showing it shrank tumors in a patient group with few treatment options. Seagen and Genmab will need to confirm its safety and effectiveness in a trial that will test whether it can help patients live longer than those on chemotherapy. The companies set the drug's list price at roughly $34,000 a month.
Tivdak gives doctors and patients another option for a disease that hasn't had many advances in treatment beyond traditional chemotherapy.
Roche's Avastin and Merck & Co.'s Keytruda are more recent entries, but have shown only modest effectiveness. Avastin added to chemotherapy improved survival by about four months compared with chemotherapy alone, while Keytruda shrunk or eliminated tumors in about 14% of patients whose cancer expressed a protein marker associated with treatment responses.
Tivdak, by comparison, has shown signs it works without chemotherapy, as Avastin does, and in a broader patient population than Keytruda does. In a small trial called InnovaTV 204 that supported accelerated approval, treatment with Tivdak shrank or eliminated tumors in 24% of patients whose cancer had progressed following Avastin plus chemo and up to one other prior therapy. Seven percent of study participants experienced complete responses to treatment.
Earlier this year, Seagen and Genmab began enrolling patients into a larger trial called InnovaTV 301 to confirm that Tivdak can help patients live longer than chemotherapy. That trial may not return results for three years, however.
Meanwhile, the two partners have been testing the treatment in patients with earlier-stage disease.
At the European Society for Medical Oncology Meeting, they released data from another trial called InnovaTV 205, which tested Tivdak in a number of combinations and settings. In patients who have never received a systemic treatment perviously, Tivdak plus chemo shrank or eliminated tumors in 55% of patients, helping them live a median of greater than nine months without their disease progressing. With Keytruda in patients following two or three prior treatments, Tivdak shank or eliminated tumors in 38% of patients and led to median progression-free survival of nearly six months.
In earlier-stage disease, however, Keytruda has shown more impressive effectiveness, reducing the risk of death by more than 30% in the KEYNOTE-826 trial, which paired it with chemotherapy and Avastin. Stephen Willey, an analyst at Stifel, wrote in a Sept. 19 note to clients that those data suggest Keytruda will need to be a part of an early-line therapy combination.
Seagen launched its first product, an antibody-drug conjugate called Adcetris, in 2011. Since late 2019, the Seattle-based biotech company has now won approvals for three more, and last year turned a profit for the first time due to revenues from license agreements. Tivdak could further added to Seagen's bottom line.