Annonce • 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. Annonce • 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. Annonce • 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. Annonce • 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. Annonce • 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. Annonce • Nov 04
Seagen Highlights First Solid Tumor Data for an ADCETRIS® (brentuximab vedotin) Immunotherapy Combination and Preclinical Data for Novel CD30-Directed Antibody-Drug Conjugate at Society for Immunotherapy of Cancer (SITC) Annual Meeting Seagen Inc. announced the first presentation of data evaluating ADCETRIS® (brentuximab vedotin) in combination with an anti-PD-1 checkpoint inhibitor in non-small cell lung cancer (NSCLC) and melanoma, and shared preclinical data for an investigational CD30-directed antibody-drug conjugate (ADC) that uses a novel tripeptide linker. The studies were presented at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting, taking place November 3-5, 2023, in San Diego. Phase 2 Study of ADCETRIS plus Pembrolizumab in Solid Tumors The Phase 2 trial SGN35-033 explored the combination of ADCETRIS with pembrolizumab in 55 patients with non-small cell lung cancer (NSCLC) and 58 patients with melanoma who either had no response to previous anti-PD-1 treatment or who experienced cancer progression after initial response to anti-PD-1 therapy (primary resistant or secondary refractory disease, respectively). NSCLC cohorts were evaluated using RECIST v1.1 and melanoma cohorts were evaluated using immune RECIST (iRECIST). In NSCLC, the ADCETRIS and pembrolizumab combination demonstrated an objective response rate (ORR) of 8% (95% CI: 0.2, 38.5) and 14% (95% CI: 5.3, 27.9) in patients with primary (n=12) and secondary (n=43) refractory NSCLC, respectively. Disease control rates (DCR) — inclusive of complete responses, partial responses and stable disease — were 67% (CI: 34.9, 90.1) and 72% (CI: 56.3, 84.7), respectively. In melanoma, the ADCETRIS and pembrolizumab combination demonstrated an ORR of 18% (95% CI: 3.8, 43.4) and 22% (95% CI: 10.6, 37.6), in primary (n=17) and secondary (n=41) refractory metastatic cutaneous melanoma, respectively. DCRs were 71% (CI: 44.0, 89.7) and 80% (CI: 65.1, 91.2), respectively. The study design included melanoma patients who were treated in the study within 90 days of receiving prior anti-PD-1 therapy. The safety profile of ADCETRIS was consistent with previous studies, and no new safety signals were observed. Increased CD8 T cell infiltration was observed in the tumor microenvironment of patients who responded to the combination treatment, suggesting potential re-sensitization to PD-1 inhibitors. The study is currently enrolling patients in previously untreated NSCLC and head and neck cancer. SGN-35T, a Novel ADC SGN-35T is a next generation CD30-directed ADC that uses a novel tripeptide linker designed to preferentially release its cytotoxic payload in tumor cells to limit off-target toxicity. Preclinical data suggest that SGN-35T may be highly effective, like ADCETRIS, with the potential for improved tolerability. SGN-35T is an investigational agent, and its safety and efficacy have not been established. In this in vitro study, SGN-35T was cytotoxic to CD30-expressing tumor cells and CD30-expressing regulatory T cells, whereas CD8-expressing T cells were unaffected by SGN-35T. The observations support future clinical investigation of SGN-35T in solid tumors. Annonce • Oct 17
Seagen Inc. Announces to Highlight Overall Survival Data for Padcev and Tivdak During Presidential Symposium At Esmo Congress 2023 Seagen Inc. 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. 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. Tucatinib: Impact of baseline molecular alterations on the efficacy of tucatinib (TUC) plus trastuzumab (Tras) for 5510 Proffered Paper J. Strickler HER2+, RAS WT metastatic CRC (mCRC) in MOUNTAINEER (Oral Presentation). Phase 2 dose optimization results from MOUNTAINEER-02: A study of tucatinib, trastuzumab, ramucirumab, 1523P Poster M. Tehfe and paclitaxel for HER2+ gastroesophageal cancer (GEC). First-in-human study of SGN-B7H4V, a B7-H4-directed vedotin ADC, in patients with advanced solid tumors: 660MO Mini Oral Presentation C. Perez; Preliminary results of a phase 1 study (SGNB7H4V-001). PADCEV (en Fortumab vedotin- ejfv) U.S. Indication & Important Safety Information: 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. Skin reactions occurred in 56% (all grades) of the 753 patients treated with PADCEV in combination with pembrolizumab in clinical trials. Patients with baseline hemoglobin A1C 8% were excluded from clinical trials. In clinical trials of PADCEV as a single agent, 14% of the 753 patients treated With PADCEV developed hyperglycemia; Of the 753 patients treated with the PADCEV was not reported in the first cycle of treatment, which occurred predominantly during the first cycles of treatment, but may occurred later. Skin reactions occurred in56% (all grades) of The 753 patients treated with P ADCEV as a single agent in clinical trials. Skin reactions occurred in 72% (all grades) of the 121 patients treated with PADCE V in combination with pembrolIZumab in clinical trials. patients with baseline hemoglobin A1c 8% were excluded from clinical trial. In clinical trials of P ADCEV as asingle agent, 14% of the753 patients treated with PAD CEV developed hyperglycemia. Of the 753 patients treated in PADCEV is a single agent in the first cycle of treatment. 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. Annonce • Oct 13
Seagen Inc. to Report Q3, 2023 Results on Nov 01, 2023 Seagen Inc. announced that they will report Q3, 2023 results on Nov 01, 2023 Annonce • Sep 23
Astellas Pharma Inc. and Seagen Inc. Announces Positive Topline Results from the Phase 3 Ev-302 Clinical Trial Astellas Pharma Inc. and Seagen Inc. announced positive topline results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) for PADCEV(R) (enfortumab vedotin-ejfv) in combination with KEYTRUDA(R) (pembrolizumab) versus chemotherapy in patients with previously untreated 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. The EV-302 trial enrolled patients with previously untreated la/mUC who were eligible for cisplatin- or carboplatin- containing chemotherapy regardless of PD-L1 status. Enfortumab vedotin in combination with pembrolizumab is being investigated in an extensive program in multiple stages of urothelial cancer, including two Phase 3 clinical trials in MIBC in EV-304 (NCT04700124, also known as KEYNOTE-B15) and EV-303 (NCT03924895, also known as KEYNOTE -905). Skin reactions occurred in 56% (all grades) of the 753 patients treated with PADCEV as a single agent in clinical trials including 40% with sensory neuropathy, 7% with muscular weakness and 7% with motor neuropathy. Ocular disorders were reported in 40% of the 384 patients treated with PADCE V as a single agent in clinical trial. The trial is part of an extensive program evaluating this combination in multiple stage of urothelial cancer. Enfortumab vedotizumab vedotin and pembrolizumab are being investigated in an extensive program In MIBC in EV-304. NCT04700124, alsoknown as KEYNOTE-B 15) and EV-303 (NCT03924895, other known as KEYNOTE-905). Skin reactions occur in 56% (all grades") of the 753 patients treated With PADCEV as asingle agent in clinical trials. Skin reactions occurred in 72% (all grades) of the 121 patients treated with P ADCEV in combination with pembrolIZumab in clinical trials. Patients with baseline hemoglobin A1C =8% were excluded from clinical trials. In clinical trials of PADCEV as a Single agent, 2.9% of the 753 patients treatedwith PADCEV had pneumonia/ILD of any grade and 0.8% had Grade 3-4. Peripheral neuropathy (PN) Peripheral neuropathy occurred in 53% of the 753 patients treatment with PADCEV as an single agent in clinical trials including40% with sensory neuropathy,7% with muscular weakness and 7%.cular disorders were reported in 40%. Ocular disorders were reported in40% of the 384 patients treatment with PADCEv as a single agents in clinical trials. The study demonstrated that the combination of enfortumab vedotin, M.D., M.P.H., Senior Vice President, Head of Oncology Development, Astellas "We are thrilled that the topline results of the EV-302 study demonstrated that the combination ofEnfortumab vedotin and Pembrolizumab improved the dual primary endpoints of OS and PFS. Patients living with metastatic urothelial Cancer are in dire need of additional treatment options and this combination has the potential to advance the standard of care. 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. In April 2023, the U.S. Food and Drug Administration (FDA) granted an accelerated approval to PADCEV in combination with KEYTRUda for the treatment of adult patients with la/mUC for the treatment of the treatment of adult patients with a single agent. Annonce • Sep 05
Seagen Inc. and Genmab A/S Announce That Tivdak(R) (Tisotumab Vedotin-Tftv) Met Its Primary Endpoint of Improved Overall Survival in Patients with Recurrent or Metastatic Cervical Cancer Compared to Chemotherapy Genmab A/S and Seagen Inc. announced that the Phase 3 innovaTV 301 global trial in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy who received TIVDAK® (tisotumab vedotin-tftv), compared with chemotherapy alone, met its primary endpoint of overall survival (OS). An Independent Data Monitoring Committee determined that OS crossed the pre-specified efficacy boundary at interim analysis. The key secondary endpoints of investigator-assessed progression-free survival and objective response rate also demonstrated statistical significance. The safety profile of TIVDAK in innovaTV 301 is consistent with the known safety profile of TIVDAK as presented in the U.S. prescribing information, and no new safety signals were observed. The results of innovaTV 301/ENGOT cx-12/GOG 3057, a global, randomized, open-label Phase 3 trial, add to the previous results of innovaTV 204, which served as the basis for the accelerated approval of TIVDAK in the United States. 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. The innovaTV 301 China extension study has been initiated and continues to enroll patients, in collaboration with Zai Lab Limited. Annonce • Aug 17
Seagen Inc. Announces Phase 3 HER2CLIMB-02 Clinical Trial of TUKYSA®? (tucatinib) in Combination with Antibody-Drug Conjugate Ado-Trastuzumab Emtansine Seagen Inc. announced that the Phase 3 HER2CLIMB-02 clinical trial of TUKYSA® (tucatinib) in combination with the antibody-drug conjugate ado-trastuzumab emtansine (Kadcyla®) met its primary endpoint of progression-free survival (PFS). Patients in the trial had unresectable locally advanced or metastatic human epidermal growth factor receptor 2-positive (HER2-positive) breast cancer and had received previous treatment with a taxane and trastuzumab.? Overall survival (OS) data, a secondary endpoint, are not yet mature. Discontinuations due to adverse events were more common in the combination arm of the trial, but no new safety signals emerged for the combination. HER2CLIMB-02 is a global, multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical trial of tucatinib in combination with ado-trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic or unresectable breast cancer (MBC) who have had prior treatment with a taxane and trastuzumab in any setting. Trial enrollment began in 2019. The primary endpoint of the trial is PFS per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator assessment. OS, PFS by blinded independent committee review (BICR), objective response rate, duration of response, PFS and OS in patients with brain metastases at baseline, and safety and tolerability of the combination regimen are secondary objectives. TUKYSA is currently approved in the U.S. in combination with trastuzumab and capecitabine for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. Seagen has a robust development program for TUKYSA, including a study with registrational intent in first-line maintenance with trastuzumab and pertuzumab (HER2CLIMB-05). Seagen is also supporting a cooperative group study in adjuvant high-risk HER2-positive breast cancer in combination with T-DM1. Annonce • Jul 13
Seagen Inc. to Report Q2, 2023 Results on Aug 02, 2023 Seagen Inc. announced that they will report Q2, 2023 results on Aug 02, 2023 Annonce • Jun 21
Seagen Inc. Announces Phase 3 Trial of Adcetris (Brentuximab Vedotin) with Modified Chemo Regimen Shows Non-Inferiority with Unprecedented 3-Year Progression Free Survival of 94.9% Vs Less Tolerable International Standard of Care in Advanced Classical Hodgkin Lymphoma Seagen Inc. announced that the clinical research cooperative German Hodgkin Study Group (GHSG) presented results showing that a phase 3 trial of ADCETRIS®? in combination with chemotherapy - a regimen called BrECADD (brentuximab vedotin [ADCETRIS, etoposide, cyclophosphamide, doxorubicin [Adriamycin, dacarbazine, and dexamethasone) - met its co-primary endpoints of non-inferior efficacy and superior tolerability versus a highly efficacious yet chemotherapy-intense treatment regimen of escalated BEACOPP (bleomycin, etoposide, doxorubic in (Adriamycin), cyclophosphamide, vincristine, procarbazine, and prednisone), which is an international standard of care in the frontline advanced classical Hodgkin lymphoma (cHL) setting and commonly used in Europe. Both study arms used PET scans to guide treatment decisions. The data results of the HD21 study were presented in a late-breaking session at the 17thInternational Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland on June 17. An interim analysis at 40 months showed an unprecedented 94.9% 3-year progression-free survival (PFS) (99% CI: 92.8, 97.1) for patients treated with the ADCETRIS combination of BrECADD versus 92.3% for eBEACOPP (99% CI: 89.7, 94.9). Hodgkin lymphoma is distinguished by the presence of Reed-Sternberg cells that usually have a protein called CD30 on their surface. Approximately 8,830 cases of classical Hodgkin lymphoma will be diagnosed in the United States during 2023 and 900 people will die from the disease. According to the International Agency for Research on Cancer in 2020, over 83,000 people worldwide were diagnosed with Hodgkin lymphoma and approximately 23,000 people died from this cancer. Annonce • Jun 13
Seagen Announces ADCETRIS® (brentuximab vedotin) Plus Novel Immunotherapy Combination Delivers 98% Overall Response Rate and 93% Complete Response Rate in Patients with Early-Stage Classical Hodgkin Lymphoma (cHL) Seagen Inc. announced updated efficacy and safety results from Part C of a phase 2 single-arm trial (SGN35-027) evaluating the antibody-drug conjugate ADCETRIS® (brentuximab vedotin) in combination with the PD-1 inhibitor nivolumab and standard chemotherapy agents doxorubicin and dacarbazine (AN+AD) for the frontline treatment of patients with early-stage classical Hodgkin lymphoma (cHL). Also, to be presented in a late-breaking session, are three-year results from a 1,500-patient phase 3 trial from the German Hodgkin Study Group (HD21) evaluating non-inferiority efficacy and potential for reduced toxicity of an ADCETRIS regimen (BrECADD) compared to the highly efficacious yet chemotherapy intensive escalated BEACOPP regimen, commonly used outside of the U.S. The study will be presented on June 17, 2023. ADCETRIS + AVD chemotherapy (Adriamycin, vinblastine, dacarbazine) is a U.S. standard of care in advanced-stage cHL based on national treatment guidelines and is the only targeted therapy inclusive regimen that has a proven statistically significant overall survival benefit at 6-years of follow-up, reducing risk of death by 41% for these patients. ADCETRIS is approved for seven indications in the U.S. and five indications in Europe, where Takeda has commercialization rights. Of 154 patients with early-stage disease in Part C of the study, 150 were included at the time of efficacy assessment, showing: A 98% ORR (95% CI: 94.3, 99.6) and a 93% CR rate (95% CI: 87.3, 96.3) at end of treatment (EOT). Follow-up is ongoing and progression-free survival (PFS) results are not yet available. The most frequently reported treatment-related treatment-emergent adverse events (TRAEs) of any grade occurring in more than 30% of patients were nausea (65%), peripheral sensory neuropathy (47%) and fatigue (44%). Peripheral sensory neuropathy was primarily low grade (3% Grade =3). There were no cases of febrile neutropenia. Immune-mediated AEs observed to date are consistent with the individual safety profile of nivolumab. There were no grade 5 adverse events. Updated data results from Part B of the study in patients with advanced-stage disease (n=57) were presented at the European Hematology Association 2023 Congress in Frankfurt, Germany June 8-11, which showed an estimated 95% 12-month PFS rate and 93% 18-month PFS rate, an ORR of 95% and CR rate of 89% at EOT. The most frequently reported TRAEs of any grade occurring in more than 30% of patients were nausea (65%), fatigue (49%), peripheral sensory neuropathy (44%) and alopecia (35%). Reported Earnings • Jul 29
Second quarter 2022 earnings released: US$0.73 loss per share (vs US$0.47 loss in 2Q 2021) Second quarter 2022 results: US$0.73 loss per share (down from US$0.47 loss in 2Q 2021). Revenue: US$497.5m (up 28% from 2Q 2021). Net loss: US$134.8m (loss widened 59% from 2Q 2021). Over the next year, revenue is forecast to grow 21%, compared to a 214% growth forecast for the industry in Mexico. Board Change • Jul 18
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 1 experienced director. 5 highly experienced directors. Independent Director Ted Love was the last director to join the board, commencing their role in 2020. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Board Change • May 31
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 1 experienced director. 5 highly experienced directors. Independent Director Ted Love was the last director to join the board, commencing their role in 2020. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.