Seagen did not address rumors of a buyout from Merck during its fourth-quarter and full-year financial report. Instead, it focused on upcoming label expansions and its promising pipeline.
Seagen CEO David R. Epstein/Bloomberg/Getty Images
Seagen did not address rumors of a buyout from Merck during its fourth-quarter and full-year financial report Wednesday.
Instead, the Washington-based biotech focused on upcoming label expansions and its promising pipeline.
For 2023, Seagen’s growth will depend greatly on its four approved products: Adcetris (brentuximab vedotin), Padcev (enfortumab vedotin-ejfv), Tukysa (tucatinib) and tivdak (tisotumab vedotin-tftv). For these, the company is anticipating several key data readouts or regulatory milestones this year, David Epstein, CEO, Seagen, said in an investor call.
“We are executing robust clinical development programs, including 10 potentially registrational studies for our approved products in areas of opportunity spanning multiple tumor types,” Epstein said.
In November 2022, Adcentris won FDA approval for pediatric Hodgkin lymphoma, expanding its label to include patients aged two years and above with high-risk disease.
A month later, the drug met its primary endpoint in a multi-part Phase II trial in classical Hodgkin lymphoma when combined with Bristol Myers Squibb’s Opdivo (nivolumab). This could pave the way for another label expansion for Adcetris.
Adcetris is now standard-of-care in front-line Hodgkin lymphoma, and following its most recent regulatory nod, is indicated for seven malignancies. Seagen expects Adcetris to hit blockbuster status in 2023, Epstein said.
The company also sees blockbuster potential in Padcev, its bladder cancer therapeutic, which it hopes to grow into a strong franchise in this space by expanding its utility into earlier stages of the disease, including muscle- and non-muscle-invasive forms of bladder cancer.
The FDA has granted priority review for Padcev’s accelerated approval application for the first-line treatment of metastatic bladder cancer, in combination with Merck’s Keytruda (pembrolizumab), in patients who are cisplatin-ineligible. with a target action date of Apr. 21, Epstein said.
Padcev is also approved for locally advanced or metastatic urothelial cancer, and Seagen is continuing to study the drug beyond bladder cancer.
Tukysa is a best-in-class tyrosine kinase inhibitor approved for HER2-positive metastatic breast and colorectal cancer. For the coming year, Seagen is gearing up for several product launches for Tukysa outside the U.S., Epstein said.
The FDA recently granted the treatment accelerated approval in patients with previously treated, RAS wild-type, HER2-positive metastatic colon cancer.
Seagen’s fourth major growth driver for 2023 is its newest commercial product Tivdak, a first-in-class antibody-drug conjugate (ADC) approved as a second-line treatment for metastatic cervical cancer. The company is seeking to expand Tivdak’s label to head and neck cancer.
Beyond these four approved products, Seagen is also advancing three promising ADC candidates to support its longer-term growth. These include disitamab vedotin for HER2+ metastatic urothelial cancer and other HER2-expressing solid tumors; SGN-B6A, which targets integrin beta-6; and SGN-B7H4V, which binds the B7-H4 immune checkpoint protein.
