Duyuru • Dec 26
Seagen Inc. Files Form 15 Seagen Inc. has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its common stock under the Securities Exchange Act of 1934, as amended. The par value of the company's common stock was $0.001 per share. Duyuru • Dec 11
Seagen Inc. Announces Phase 2 Study Evaluating the Antibody-Drug Conjugate ADCETRIS (brentuximab Vedotin) in Combination with the PD-1 Inhibitor Nivolumab and Standard Chemotherapy Agents Doxorubicin and Dacarbazine Seagen Inc. announced that clinically meaningful progression-free survival (PFS), a secondary endpoint, was observed in a Phase 2 study evaluating the antibody-drug conjugate (ADC) ADCETRIS® (brentuximab vedotin)in combination with the PD-1 inhibitor nivolumab and standard chemotherapy agents doxorubicin and dacarbazine (AN+AD) as first-line treatment for early and advanced stage classical Hodgkin lymphoma (cHL). This is the first time 12-month PFS results were presented for the treatment combination, which avoids use of vinblastine and bleomycin in patients with early stage cHL. Results from the trial, called SGN35-027, were presented in an oral session at the 65thAmerican Society of Hematology Annual Meeting & Exposition in San Diego. Oral #611: Brentuximab vedotin, nivolumab, doxorubicin, and dacarbazine (AN+AD) for early-stage classical Hodgkin lymphoma: Updated results reporting progression-free survival in an ongoing Phase 2 study (SGN35-027 Part C): SGN35-027 Part C is investigating the novel ADCETRIS combination in 154 patients with early stage (non-bulky Stage I or II) cHL. Among 150 efficacy-evaluable patients, 98% had an overall response (OR) (95% CI: 94.3, 99.6) and 93% had a complete response (CR) (95% CI:88.1, 96.8) at the end of treatment. 99% of patients who responded (95% CI: 95.0, 99.9) had a duration of response (DOR) beyond 12 months; 98% of patients who had a complete response (95% CI: 93.7, 99.6) had a duration of CR (DOCR) beyond 12 months. The PFS rate was 100% (95% CI: 100, 100) at 12 months and 97% (95% CI: 90.3, 99.1) at 18 months. The most frequently reported treatment-emergent adverse events (TEAEs) Grade 3 or higher were neutropenia (9%), increased alanine aminotransferase (7%), and increased aspartate aminotransferase (5%). Peripheral sensory neuropathy was primarily low grade (3% Grade =3). There were no cases of febrile neutropenia and no deaths. Treatment-emergent immune-mediated adverse events (IMAEs) were primarily low-grade and consistent with the individual safety profile of nivolumab. Oral #608: Brentuximab vedotin, nivolumab, doxorubicin, and dacarbazine for advanced stage classical Hodgkin lymphoma: Updated efficacy and safety results from the single arm Phase 2 study (SGN35-027 Part B): SGN35-027 Part B is investigating the novel ADCETRIS combination in 57 patients with advanced-stage cHL (Stage II with bulky disease, Stage III or IV). Among 56 efficacy-evaluable patients, 95% had an OR (95% CI: 85.1, 98.9) and 89% had a CR (95% CI: 78.1, 96.0). 88% of patients who responded (95% CI: 75.7, 94.6) had a DOR beyond 24 months; 88% of patients who had a CR (95% CI: 76.0, 94.6) had a DOCR beyond 24 months. The estimated PFS rate at 24 months was 88% (95% CI: 75.7, 94.6), with a median follow-up of 24.2 months (95% CI: 23.4, 26.9). The most frequently reported TEAEs Grade 3 or higher were increased alanine aminotransferase (11%) and neutropenia (9%). Peripheral sensory neuropathy was primarily low grade (4% Grade =3). No febrile neutropenia and no deaths were reported. IMAEs were primarily low-grade and consistent with the individual safety profile of nivolumab. No subsequent radiation therapy was given to patients. ADCETRIS is a proven foundation of care for CD30-expressing lymphomas with more than 120,000 patients treated globally across seven indications. In combination with Adriamycin, vinblastine and dacarbazine (AVD) chemotherapy, ADCETRIS is the first medicine to include overall survival data in its Prescribing Information for previously untreated Stage III/IV cHL. Duyuru • Dec 06
Seagen Inc. Announces Data from the Phase 3 HER2CLIMB-02 Clinical Trial of TUKYSA Seagen Inc. announced data from the Phase 3 HER2CLIMB-02 clinical trial of TUKYSA (tucatinib) in combination with the antibody-drug conjugate ado-trastuzumab emtansine (Kadcyla). The combination showed a statistically significant improvement in progression-free survival (PFS), the study's primary endpoint, in patients with unresectable locally advanced or metastatic human epidermal growth factor receptor 2-positive (HER2-positive) breast cancer who had been previously treated with trastuzumab and a taxane, compared to those who received placebo plus ado-trastuzumib emtansine. Discontinuations due to adverse events were more common in the combination arm of the trial, but no new safety signals were observed for the combination. Patients who received TUKYSA in combination with ado-trastuzum AB emtansine experienced: Median PFS of 9.5 months (95% Confidence Interval [CI]: 7.4, 10.9) by investigator assessment per RECIST v1.1 compared to 7.4 months (95% CI: 5.6, 8.1) in the placebo plus ado-trastizumab emtansine arm (Hazard Ratio [HR], 0.76 [95% CI: 0.61, 0.95); P=0.0163). The most common (5%) Grade 3 or higher adverse events (AEs) were alanine transferase (ALT) increase (16.5% versus 2.6%), aspartate transferase (AST) increase (16.5%. anemia (8.2% versus 4.7%), thrombocytopenia (7.4% versus 2.1%), and fatigue (6.1% versus 3.0%). TUKYSA in combination With trastuzumab and capecitabine is approved by the U.S. Food and Drug Administration (FDA) based on the results of the HER2CLIMB trial and is the only Category 1 preferred recommendation by the National Comprehensive Cancer Network for third-line metastatic HER2-positive breast cancer. Duyuru • Dec 02
Astellas Pharma Inc. and Seagen Inc. Announces FDA Grants Priority Review for Supplemental Biologics License Application of Padcev with Keytruda for First-Line Treatment of Advanced Bladder Cancer Astellas Pharma Inc. and Seagen Inc. announced that on November 30, 2023 the U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental Biologics License Application (sBLA) for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) as a combination therapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC), a form of bladder cancer that has spread to surrounding organs or muscles, or other parts of the body. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of May 9, 2024. The FDA is reviewing the application under its Real-Time Oncology Review (RTOR) program, which aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible. If approved, this combination would be the first treatment option for cisplatin eligible and ineligible patients. In the U.S., it is estimated that 82,290 people will be diagnosed with bladder cancer in 2023. Urothelial cancer accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter and urethra. Approximately 12% of cases are locally advanced or metastatic urothelial cancer at diagnosis. Most la/mUC patients will progress within nine months and long-term survival rates are poor. The sBLA for first-line use of the combination is based on results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39). The study found that the combination improved overall survival (OS) and progression-free survival (PFS) with statistically significant and clinically meaningful results in patients with previously untreated la/mUC compared to platinum-containing chemotherapy. The safety results were consistent with those previously reported with this combination, and no new safety issues were identified. Duyuru • Dec 01
Seagen Inc. Announces FDA Grants Priority Review for Supplemental Biologics License Application (sBLA) of PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer Seagen Inc. announced that on November 30, 2023 the U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental Biologics License Application (sBLA) for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) as a combination therapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC), a form of bladder cancer that has spread to surrounding organs or muscles, or other parts of the body. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of May 9, 2024. The FDA is reviewing the application under its Real-Time Oncology Review (RTOR) program, which aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible. If approved, this combination would be the first treatment option for cisplatin eligible and ineligible patients. In the U.S., it is estimated that 82,290 people will be diagnosed with bladder cancer in 2023.i Urothelial cancer accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.ii Approximately 12% of cases are locally advanced or metastatic urothelial cancer at diagnosis.iii Most la/mUC patients will progress within nine months and long-term survival rates are poor. The sBLA for first-line use of the combination is based on results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39). The study found that the combination improved overall survival (OS) and progression-free survival (PFS) with statistically significant and clinically meaningful results in patients with previously untreated la/mUC compared to platinum-containing chemotherapy. The safety results were consistent with those previously reported with this combination, and no new safety issues were identified. In February 2020, PADCEV in combination with KEYTRUDA was granted Breakthrough Therapy designation by the FDA and the EV-103 sBLA received Priority Review designation in December 2022. In April 2023, the FDA granted accelerated approval to the combination for the treatment of adult patients with la/mUC who are not eligible to receive cisplatin-containing chemotherapy based on tumor response rate and durability of response from the EV-103 trial. The EV-302 trial, which is intended to serve as the confirmatory trial for the U.S. accelerated approval and as the basis for global regulatory submissions, is also intended to expand the indication into the cisplatin-eligible patient population. 