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
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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
EV-302 is a global, randomized Phase 3 study that evaluated PADCEV, developed in partnership with Astellas, in combination with
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
TIVDAK is being developed in partnership with
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
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.
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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
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Email: dcaouette@seagen.com
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