BOTHELL - Seagen Inc. (Nasdaq: SGEN) today announced the upcoming presentation of detailed results from two pivotal Phase 3 studies at the ESMO Congress 2023.

Results from the EV-302 study of PADCEV (enfortumab vedotin-ejfv) plus KEYTRUDA (pembrolizumab) in locally advanced or metastatic urothelial cancer (la/mUC) in the first-line setting will be presented during a Presidential Symposium at the Congress. Seagen will also present results from the innovaTV 301 study of TIVDAK (tisotumab vedotin-tftv) compared with chemotherapy in adults with recurrent or metastatic cervical cancer during the same Presidential Symposium. Both presentations are included in the ESMO Communication Activities. Seagen is sharing a total of six abstracts, including five oral presentations at ESMO this year, taking place October 20-24, 2023 in Madrid, Spain.

'Seagen is excited to share these new overall survival data and the prospect of PADCEV and TIVDAK to benefit people living with cancer. We are also proud of the antibody-drug conjugate technology that Seagen has pioneered for 25 years and its impact on the treatment of cancer,' said Roger Dansey, M.D., President, Research and Development and Chief Medical Officer at Seagen. 'From the beginning, we have been driven by science with the goal of advancing innovation to improve and extend the lives of people with cancer who have few treatment options. We look forward to discussing these latest pivotal data with regulatory authorities as we work to bring transformative care to more patients.'

Committed to Transforming Care in Bladder Cancer with PADCEV

PADCEV data will detail results of the EV-302 study, which met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS), compared to chemotherapy. An Independent Data Monitoring Committee determined that OS crossed the pre-specified efficacy boundary at interim analysis. The safety results of the combination are consistent with those of PADCEV in combination with pembrolizumab previously reported in cisplatin-ineligible patients with la/mUC. The EV-302 trial is intended to serve as the basis for global submissions and as the confirmatory trial for the U.S. accelerated approval of this combination.

EV-302 is a global, randomized Phase 3 study that evaluated PADCEV, developed in partnership with Astellas, in combination with Merck's anti-PD-1 therapy KEYTRUDA in the first-line setting for adult patients with locally advanced or metastatic urothelial cancer, who were eligible for cisplatin- or carboplatin-containing chemotherapy regardless of PD-L1 status.

Additional PADCEV data that will be shared at ESMO include results from EV-103 Cohort L, which show the potential of PADCEV as a monotherapy in cis-ineligible patients with muscle invasive bladder cancer (MIBC). Due to high rates of recurrence in cis-ineligible MIBC patients, there is an urgent need for effective treatment options.

Aiming to Address Unmet Need in Cervical Cancer with TIVDAK

Detailed results from the global Phase 3 innovaTV 301 study evaluating TIVDAK in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy who received TIVDAK, compared with chemotherapy alone, will also be highlighted at ESMO. An Independent Data Monitoring Committee determined that OS crossed the pre-specified efficacy boundary at interim analysis. The key alpha-controlled secondary endpoints of investigator-assessed progression-free survival and objective response rate also demonstrated statistical significance. The safety profile of TIVDAK in innovaTV 301 was consistent with the known safety profile of TIVDAK as presented in the U.S. prescribing information, and no new safety signals were observed.

TIVDAK is being developed in partnership with Genmab. Subject to discussions with regulatory authorities, the results from innovaTV 301 are intended to serve as the pivotal confirmatory trial for the U.S. accelerated approval and support global regulatory applications.

Advancing a Pipeline of Novel Targeted Cancer Therapies

Early clinical data from a Phase 1 study of SGN-B7H4V, a wholly owned vedotin ADC directed to B7-H4, will be shared at ESMO. B7-H4 is a member of the B7 family of immune checkpoint ligands and its expression is elevated on a variety of solid tumors, including breast, ovarian, and endometrial cancers.

BOXED WARNING: SERIOUS SKIN REACTIONS

PADCEV can cause severe and fatal cutaneous adverse reactions including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which occurred predominantly during the first cycle of treatment, but may occur later.

Closely monitor patients for skin reactions.

Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions.

Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions.

Indication

PADCEV, as a single agent, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who: have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, or are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.1

PADCEV, in combination with pembrolizumab, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who are not eligible for cisplatin-containing chemotherapy.1

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

About Seagen

Seagen Inc. is a global biotechnology company that discovers, develops and commercializes transformative cancer medicines to make a meaningful difference in people's lives. Seagen is headquartered in the Seattle, Washington area, and has locations in California, Canada, Switzerland and the European Union.

Forward-Looking Statements

Certain statements made in this press release are forward looking, such as those, among others, relating to the therapeutic potential of PADCEV, TIVDAK, TUKYSA (tucatinib), SGN-B7H4V and the company's other products and product candidates, including their potential efficacy, safety and therapeutic uses, plans to discuss results from the EV-302 and innovaTV 301 trials with regulatory authorities; the potential for results from the EV-302 and innovaTV 301 trials to serve as confirmatory trials for the U.S. accelerated approvals of PADCEV and TIVDAK, respectively, or to support global regulatory applications and Seagen's pipeline. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include, without limitation, the difficulty and uncertainty of pharmaceutical product development, including the risks that the company may experience delays in its clinical trials or otherwise experience failures or setbacks in its clinical development programs due to lack of efficacy, adverse events or other factors, and that adverse regulatory actions may occur. More information about the risks and uncertainties faced by Seagen is contained under the caption 'Risk Factors' included in the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, filed with the Securities and Exchange Commission. Seagen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contact:

David Caouette

Tel: (310) 430-3476

Email: dcaouette@seagen.com

(C) 2023 Electronic News Publishing, source ENP Newswire