Business Wire

Seagen Announces Preliminary Results from Phase 2 Clinical Trial of ADCETRIS® (brentuximab vedotin) in Novel Combination of Agents for Patients with Advanced Stage Classical Hodgkin Lymphoma

Share

Seagen Inc. (Nasdaq:SGEN) today announced promising efficacy and safety results from Part B of an open-label, phase 2 clinical trial evaluating ADCETRIS ® (brentuximab vedotin) in a novel combination with nivolumab, doxorubicin, and dacarbazine (AN+AD) as a frontline treatment for patients with advanced stage classical Hodgkin lymphoma (cHL). Data from this preliminary analysis were presented (Abstract #2454) as part of a poster presentation at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition in Atlanta.

The preliminary results demonstrated a complete response rate of 88 percent (95% CI: 75.9, 94.8) and overall response rate of 93 percent (95% CI: 82.7, 98.0) among 56 patients who had an end of treatment assessment on or prior to the data cutoff date. Patients received up to six cycles of treatment and were evaluated after two cycles of therapy and at the end of treatment. AN+AD was well-tolerated and no new safety signals were observed.

“I am excited about this combination of brentuximab vedotin and nivolumab along with a simplified chemotherapy regimen for the frontline treatment of patients with advanced stage classical Hodgkin lymphoma,” said Hun Ju Lee, M.D., Associate Professor of Medicine, Department of Lymphoma and Myeloma, MD Anderson Cancer Center, Houston. “This combination demonstrated a low incidence of peripheral neuropathy and the absence of febrile neutropenia. What we are learning from our research is that the use of two active targeted agents with distinct and complementary mechanisms of action in the first-line setting shows promising activity and a tolerable safety profile.”

“We are optimistic about novel combination approaches to improve outcomes in patients following a diagnosis of classical Hodgkin lymphoma, and we are encouraged by these data evaluating ADCETRIS plus nivolumab, doxorubicin and dacarbazine as a first-line therapy,” said Roger Dansey, M.D., Chief Medical Officer at Seagen. “We look forward to complete results from this trial and adding to the breadth of evidence for ADCETRIS in the treatment of advanced classical Hodgkin lymphoma.”

Efficacy:

  • Among 56 patients who had an end of treatment assessment on or prior to the data cutoff date, there was a complete response rate of 88 percent (95% CI: 75.9, 94.8) and overall response rate of 93 percent (95% CI: 82.7, 98.0).

Safety:

  • The most frequently reported treatment-related treatment-emergent adverse events (AEs) occurring in more than 20 percent of patients who received AN+AD included nausea (65%), fatigue (46%), peripheral sensory neuropathy (39%), alopecia (35%), diarrhea (30%) and constipation (25%).
  • Immune-mediated AEs were observed in 18 patients (32%) and eight patients (14%) experienced treatment-related treatment-emergent serious AEs.
  • Two patients (4%) experienced Grade > 3 peripheral neuropathy and no patients discontinued treatment due to peripheral neuropathy. No febrile neutropenia was observed, and there were no Grade 5 adverse events.

See ADCETRIS U.S. Important Safety Information, including Boxed Warning, below.

About the SGN35-027 Clinical Study

SGN35-027 is an ongoing open-label, multiple part, multicenter, phase 2 clinical trial evaluating two brentuximab vedotin treatment combinations in patients with advanced stage classical Hodgkin lymphoma. The trial includes three parts (Parts A, B, and C). Part A includes a combination of brentuximab vedotin and doxorubicin, vinblastine and dacarbazine (A+AVD), while Parts B and C include brentuximab vedotin in combination with nivolumab, doxorubicin, and dacarbazine (AN+AD). The primary endpoint for Part A is the proportion of patients with treatment-emergent incidence of rate of febrile neutropenia. The primary endpoint for Parts B and C is the proportion of participants with complete response at end of treatment, according to the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC). Key secondary endpoints include safety, tolerability, ORR, and PFS. Incidence of adverse events is a secondary endpoint for Parts B and C.

About Classical Hodgkin Lymphoma

Classical Hodgkin lymphoma (cHL), Hodgkin disease, or Hodgkin, 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 Hodgkin lymphoma. In 2021, it is estimated that there will be 8,830 new cases of Hodgkin lymphoma and an estimated 960 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:

  • previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine,
  • cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation,
  • cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates,
  • previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone,
  • sALCL after failure of at least one prior multi-agent chemotherapy regimen, and
  • primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides who have received prior systemic therapy.

ADCETRIS has received marketing authorization in more than 70 countries for certain types of relapsed or refractory Hodgkin lymphoma and sALCL.

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

  • Peripheral neuropathy (PN): ADCETRIS causes PN that is predominantly sensory. Cases of motor PN have also been reported. ADCETRIS-induced PN is cumulative. Monitor for symptoms such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness. Institute dose modifications accordingly.
  • Anaphylaxis and infusion reactions: Infusion-related reactions (IRR), including anaphylaxis, have occurred with ADCETRIS. Monitor patients during infusion. If an IRR occurs, interrupt the infusion and institute appropriate medical management. If anaphylaxis occurs, immediately and permanently discontinue the infusion and administer appropriate medical therapy. Premedicate patients with a prior IRR before subsequent infusions. Premedication may include acetaminophen, an antihistamine, and a corticosteroid.
  • Hematologic toxicities: Fatal and serious cases of febrile neutropenia have been reported with ADCETRIS. Prolonged (≥1 week) severe neutropenia and Grade 3 or 4 thrombocytopenia or anemia can occur with ADCETRIS.

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.

  • Serious infections and opportunistic infections: Infections such as pneumonia, bacteremia, and sepsis or septic shock (including fatal outcomes) have been reported in ADCETRIS-treated patients. Closely monitor patients during treatment for bacterial, fungal, or viral infections.
  • Tumor lysis syndrome: Closely monitor patients with rapidly proliferating tumor and high tumor burden.
  • Increased toxicity in the presence of severe renal impairment: The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with severe renal impairment compared to patients with normal renal function. Avoid use in patients with severe renal impairment.
  • Increased toxicity in the presence of moderate or severe hepatic impairment: The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with moderate or severe hepatic impairment compared to patients with normal hepatic function. Avoid use in patients with moderate or severe hepatic impairment.
  • Hepatotoxicity: Fatal and serious cases have occurred in ADCETRIS-treated patients. Cases were consistent with hepatocellular injury, including elevations of transaminases and/or bilirubin, and occurred after the first ADCETRIS dose or rechallenge. Preexisting liver disease, elevated baseline liver enzymes, and concomitant medications may increase the risk. Monitor liver enzymes and bilirubin. Patients with new, worsening, or recurrent hepatotoxicity may require a delay, change in dose, or discontinuation of ADCETRIS.
  • PML: Fatal cases of JC virus infection resulting in PML have been reported in ADCETRIS-treated patients. First onset of symptoms occurred at various times from initiation of ADCETRIS, with some cases occurring within 3 months of initial exposure. In addition to ADCETRIS therapy, other possible contributory factors include prior therapies and underlying disease that may cause immunosuppression. Consider PML diagnosis in patients with new-onset signs and symptoms of central nervous system abnormalities. Hold ADCETRIS if PML is suspected and discontinue ADCETRIS if PML is confirmed.
  • Pulmonary toxicity: Fatal and serious events of noninfectious pulmonary toxicity, including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome, have been reported. Monitor patients for signs and symptoms, including cough and dyspnea. In the event of new or worsening pulmonary symptoms, hold ADCETRIS dosing during evaluation and until symptomatic improvement.
  • Serious dermatologic reactions: Fatal and serious cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with ADCETRIS. If SJS or TEN occurs, discontinue ADCETRIS and administer appropriate medical therapy.
  • Gastrointestinal (GI) complications: Fatal and serious cases of acute pancreatitis have been reported. Other fatal and serious GI complications include perforation, hemorrhage, erosion, ulcer, intestinal obstruction, enterocolitis, neutropenic colitis, and ileus. Lymphoma with preexisting GI involvement may increase the risk of perforation. In the event of new or worsening GI symptoms, including severe abdominal pain, perform a prompt diagnostic evaluation and treat appropriately.
  • Hyperglycemia: Serious cases, such as new-onset hyperglycemia, exacerbation of pre-existing diabetes mellitus, and ketoacidosis (including fatal outcomes) have been reported with ADCETRIS. Hyperglycemia occurred more frequently in patients with high body mass index or diabetes. Monitor serum glucose and if hyperglycemia develops, administer anti-hyperglycemic medications as clinically indicated.
  • Embryo-fetal toxicity: Based on the mechanism of action and animal studies, ADCETRIS can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus, and to avoid pregnancy during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS.

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 Seagen’s products and product candidates, the company’s pipeline and the advancement of its research and development 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 risk of adverse events or safety signals, the inability to show sufficient activity in clinical trials, the possibility of adverse regulatory actions, and the potential for delays or setbacks in product development and the regulatory review process. More information about the risks and uncertainties faced by the company 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 National Cancer Institute. Surveillance, Epidemiology, and End Results (SEER) Program (2021) Hodgkin lymphoma Cancer Stats. https://seer.cancer.gov/statfacts/html/hodg.html

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

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

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Temenos Announces Composable Banking Services on the Temenos Banking Cloud Platform18.1.2022 10:53:00 EET | Press release

Temenos (SIX: TEMN), the banking software company, today announced Composable Banking Services and Capabilities aligned to the BIAN (Banking Industry Architecture Network) service landscape on the Temenos Banking Cloud. In addition, Temenos delivers new banking services and technology advancements that create the market's most comprehensive, cloud-native platform for composable banking. These new banking services are showcased at Temenos Sales Kick-Off, 18-21 January and will be presented at Temenos Community Forum, 17-19 May 2022. Temenos has advanced its technology architecture and banking capabilities to deliver the most open and secure cloud-native platform for composing, extending or deploying banking capabilities at scale. New pre-composed banking services on the Temenos Banking Cloud can be rapidly consumed from a self-service portal, easily configured, extended or deployed anywhere. Composed Temenos Banking Services consist of pre-configured and pre-assembled Temenos Banking Ca

SES Appoints John-Paul Hemingway as Chief Strategy and Product Officer18.1.2022 10:50:00 EET | Press release

SES is adding a new Chief Strategy and Product Officer (CSPO) to its Senior Leadership Team, underscoring SES’s commitment to ideate, build and deliver the services and solutions that create the most value for SES customers and partners, as well as their end-users. John-Paul (JP) Hemingway is charged with translating SES's corporate vision into strategic action for the company's networks and video markets – including its target applications, strategic partnerships, portfolio of solutions, and the space and network assets required to deliver them. The newly-created function brings together the Corporate Strategy, Product, Commercial Operations, Fleet Development, Innovation and Marketing & Communications teams, and is part of SES’s drive to be the most customer-centric, product-led organisation in the industry. With Hemingway’s appointment as CSPO, SES is eliminating the role of SES Networks CEO while retaining the strong focus on its video and networks businesses and leveraging its inn

CSL Behring AG publishes Offer Prospectus on public tender offer for all publicly held shares of Vifor Pharma Ltd.18.1.2022 09:05:00 EET | Press release

Regulatory News: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220117005418/en/ AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR CSL Behring AG, Berne, Switzerland, a wholly-owned subsidiary of global biotechnology leader CSL Limited (ASX: CSL; USOTC: CSLLY), today published the offer prospectus regarding its public tender offer for all publicly held registered shares of Vifor Pharma Ltd. (SIX:VIFN; ISIN:CH0364749348), a global specialty pharmaceutical company with leadership in Iron Deficiency, Nephrology & Cardio-Renal Therapies, as indicated in the pre-announcement of the public tender offer published by CSL Limited on 14 December 2021. The transaction, has been unanimously approved by both companies’ Boards of Directors. The offer price for each registered share of Vifor Pharma Ltd. is USD 179.25 in cash. The public tender offer is subject to the offer conditions set forth in the offer prospectus, which includes the report of

Fujirebio Europe Launches the RoboBlot™ Instrument, a Fully Automated Solution for INNO-LIA® Score Assays18.1.2022 09:00:00 EET | Press release

Fujirebio Europe announced today the commercial launch of the RoboBlot instrument, a closed system for the automated processing of the widely used INNO-LIA Score assays. The instrument is manufactured by Bee Robotics Ltd. and distributed by Fujirebio Europe. The system’s pre-programmed test protocols provide start-to-finish automation of strip-based INNO-LIA Score assays, from sample addition, over strip processing, image capture, to result interpretation and where applicable laboratory information system (LIS) communication. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220117005350/en/ RoboBlot™ - an instrument for fully automated processing of INNO-LIA® tests from sample pipetting to strip reading and LiRAS® interpretation (Photo: Fujirebio) “High throughput testing and more automation are an increasingly pressing need for laboratories. The typical drawbacks of manual testing, such as long hands-on time, inconsistent ass

Fast Growing RegTech SteelEye Reports 88% Growth In 202118.1.2022 08:01:00 EET | Press release

SteelEye, the compliance technology and data analytics firm, has announced a record year of growth. Revenues increased 88 percent year-on-year in 2021 and the company now has over 120 institutional clients worldwide, with new clients including Oppenheimer Europe Ltd and JonesTrading. SteelEye – which is headquartered in the UK and has offices in London, New York, Paris, Bengaluru, and Braga – has seen increasing demand for its services as financial firms’ regulatory compliance needs have grown across the globe. In response, the business expanded to the United States last year, backed by $17 million funding rounds in 2020, and appointed RegTech veteran Brian Lynch to lead its US operations. Pressure from regulators and the increasing need to improve operational efficiency across the industry have encouraged more firms to replace legacy technologies through platforms like SteelEye. This demand is growing exponentially as remote and hybrid work patterns become the norm – requiring firms t

Faster Air Quality Mapping Thanks to Ricardo’s RapidAir Software18.1.2022 03:01:00 EET | Press release

RapidAir®, developed by the global air quality, energy and environment specialists, is the next generation dispersion modelling and policy support platform that enables users to test the impact of scenarios in minutes, supporting the identification of measures that will reduce traffic emissions and consequently improve public health. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220117005253/en/ RapidAir air quality software (Photo: Business Wire) The ground-breaking air quality dispersion modelling software has already been successfully used across Asia, Europe and the UK, supporting Clean Air Zone evaluations, traffic management measures and wider air quality management activities. In response to requests from clients, including transport and health professionals, Ricardo has developed a cloud-based RapidAir software, complimenting its consultancy offering and making the capabilities of RapidAir more accessible to profess

Megaport Announces Partnership with TD SYNNEX as Leading Network as a Service (NaaS) Vendor Partner18.1.2022 00:00:00 EET | Press release

Megaport Limited (ASX: MP1) ("Megaport"), a global leading Network as a Service (NaaS) provider, today announces a partnership with TD SYNNEX, a global IT distributor and solutions aggregator, to make Megaport’s global, private Software Defined Network (SDN) platform available to TD SYNNEX customers. “Bringing Megaport’s leading Network as a Service platform into the TD SYNNEX portfolio makes it easier for customers to modernize their network connectivity and connect quickly to leading cloud service providers,” said Rodney Foreman, Chief Revenue Officer at Megaport. “TD SYNNEX’s global scale and reach, combined with their expertise in IT solutions, makes them an ideal partner to expand our channel relationships.” "TD SYNNEX is committed to delivering IT solutions to our customers that unlock their growth," said Cheryl Neal, vice president of New Vendor Acquisition, TD SYNNEX. "Adding Megaport’s Network as a Service offerings to our vast portfolio of IT solutions enables our customers t

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom