– Full Data from Phase 3 ECHELON-1 Clinical Trial to be Submitted for Presentation at Upcoming Medical Meeting –
BOTHELL, Wash.--(BUSINESS WIRE)-- Seagen Inc. (Nasdaq:SGEN) today announced that the phase 3 ECHELON-1 clinical trial demonstrated a statistically significant improvement in overall survival (OS) (p=0.009) in patients with advanced classical Hodgkin lymphoma (cHL) following treatment with ADCETRIS (brentuximab vedotin) in combination with chemotherapy. With approximately six years median follow up, patients receiving ADCETRIS plus doxorubicin, vinblastine, and dacarbazine (A+AVD) in the frontline setting had a 41 percent reduction in the risk of death (HR 0.59; [95% CI: 0.396 to 0.879]) compared with patients receiving doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). The safety profile of ADCETRIS was consistent with previous studies and no new safety signals were observed.
“These groundbreaking results are important for patients with advanced classical Hodgkin lymphoma given that an improvement in overall survival has rarely been shown in frontline treatment of this disease,” said Roger Dansey, M.D., Chief Medical Officer at Seagen. “We look forward to presentation of the results at an upcoming medical meeting.”
ECHELON-1 is an open-label, international, randomized, phase 3 trial evaluating the safety and efficacy of frontline ADCETRIS plus AVD versus ABVD in 1,334 adult patients with stage III or IV cHL. Patients were randomly assigned to receive A+AVD or ABVD intravenously on days 1 and 15 of each 28-day cycle for up to six cycles. OS is the key secondary endpoint of the trial. The primary endpoint, modified progression free survival, served as the basis for global regulatory approvals.
Please see Important Safety Information, including BOXED WARNING, for ADCETRIS below.
ADCETRIS is approved for certain types of relapsed or refractory Hodgkin lymphoma (HL) including previously untreated Stage III/IV cHL and previously untreated peripheral T-cell lymphoma (PTCL). It has received marketing authorization in more than 75 countries and is being evaluated globally in more than 70 corporate- and investigator-sponsored clinical trials across multiple settings in lymphoma and other diseases.
About Classical Hodgkin Lymphoma
cHL is a cancer of the blood. It starts when lymphocytes, a type of white blood cell, grow out of control. People with cHL have abnormal white blood cells called Reed-Sternberg cells in their lymph nodes. These cells usually have a special protein on their surface called CD30, which is a key marker of cHL. CD30 is present in approximately 95 percent of all cases of HL. In 2022, the American Cancer Society estimates that there will be about 8,540 new cases of HL and an estimated 920 people will die of this disease in the U.S.1
About ADCETRIS
ADCETRIS is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seagen’s proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing cells.
ADCETRIS is indicated for the treatment of adult patients with:
Seagen and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seagen has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seagen and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.
ADCETRIS (brentuximab vedotin) for injection U.S. Important Safety Information
BOXED WARNING
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.
Contraindication
ADCETRIS concomitant with bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).
Warnings and Precautions
Administer G-CSF primary prophylaxis beginning with Cycle 1 for patients who receive ADCETRIS in combination with chemotherapy for previously untreated Stage III/IV cHL or previously untreated PTCL.
Monitor complete blood counts prior to each ADCETRIS dose. Monitor more frequently for patients with Grade 3 or 4 neutropenia. Monitor patients for fever. If Grade 3 or 4 neutropenia develops, consider dose delays, reductions, discontinuation, or G-CSF prophylaxis with subsequent doses.
Most Common (≥20% in any study) Adverse Reactions
Peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia, and mucositis.
Drug Interactions
Concomitant use of strong CYP3A4 inhibitors or inducers has the potential to affect the exposure to monomethyl auristatin E (MMAE).
Use in Specific Populations
Moderate or severe hepatic impairment or severe renal impairment: MMAE exposure and adverse reactions are increased. Avoid use. Advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS.
Advise patients to report pregnancy immediately and avoid breastfeeding while receiving ADCETRIS.
Please see the full Prescribing Information, including BOXED WARNING, for ADCETRIS here.
About Seagen
Seagen 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. For more information on the company’s marketed products and robust pipeline, visit www.seagen.com and follow @SeagenGlobal on Twitter.
Forward Looking Statements
Certain statements made in this press release are forward looking, such as those, among others, relating to the therapeutic potential of ADCETRIS, its safety, efficacy and therapeutic uses, plans to present results at an upcoming medical meeting, and anticipated and ongoing development activities for ADCETRIS, including clinical trial activities. 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 level of utilization and adoption of the referenced treatment regimen by prescribing physicians, competitive conditions including the availability of alternative treatment regimens, the availability and extent of reimbursement, the risk of adverse events or safety signals, the possibility of adverse regulatory actions, the risk that data may not be selected for presentation at the referenced medical meeting; and the potential for delays or setbacks in product development and the regulatory review process. More information about the risks and uncertainties faced by Seagen is contained under the caption “Risk Factors” included in Seagen’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, 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 applicable law.
1 https://www.cancer.org/cancer/hodgkin-lymphoma.html
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For Media David Caouette Vice President, Corporate Communications (310) 430-3476 dcaouette@seagen.com
For Investors Peggy Pinkston Senior Vice President, Investor Relations (425) 527-4160 ppinkston@seagen.com
Source: Seagen Inc.