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Seattle Genetics and Bristol-Myers Squibb Announce Clinical Collaboration to Evaluate Combination of Adcetris® (Brentuximab Vedotin) and Opdivo® (Nivolumab) in Hematologic MalignanciesSeattle Genetics, Inc. (Nasdaq:SGEN) and Bristol-Myers Squibb Company (NYSE:BMY) today announced that the companies have entered into a clinical trial collaboration agreement to evaluate the investigational combination of Seattle Genetics' antibody-drug conjugate (ADC (News - Alert)) Adcetris (brentuximab vedotin) and Bristol-Myers Squibb's immunotherapy Opdivo (nivolumab) in two planned Phase 1/2 clinical trials. The first trial will evaluate the combination of Adcetris and Opdivo as a potential treatment option for patients with relapsed or refractory Hodgkin lymphoma (HL), and the second trial will focus on patients with relapsed or refractory B-cell and T-cell non-Hodgkin lymphomas (NHL), including diffuse large B-cell lymphoma (DLBCL). Adcetris is an ADC directed to CD30, a defining marker of classical HL, which combines the targeting ability of a monoclonal antibody with the potency of a cell-killing agent. Opdivo is a human programmed death receptor-1 (PD-1) blocking antibody that binds to the PD-1 receptor expressed on activated T-cells. "This collaboration will expand our broad Adcetris clinical development program towards our goal of improving outcomes for patients with Hodgkin lymphoma and other CD30-expressing malignancies," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "Ultimately, our vision is to advance the treatment of cancer by exploring more targeted treatment approaches that result in enhanced activity, reduced toxicities and improved long-term results for patients. We look forward to working with Bristol-Myers Squibb to define the activity and tolerability of adding Opdivo to Adcetris, and informing this potential treatment strategy in hematologic malignancies." "Bristol-Myers Squibb continues to strengthen its broad development program for Opdivo through collaborations that explore novel combination regimens in areas of serious unmet need," said Michael Giordano, senior vice president, Head of Development, Oncology, Bristol-Myers Squibb. "We are pleased to collaborate with Seattle Genetics on clinical research focused on hematologic malignancies." The studies are expected to begin in 2015, with Seattle Genetics conducting the HL trial and Bristol-Myers Squibb conducting the NHL trial. Additional details of the collaboration were not disclosed. Adcetris is approved in relapsed HL and systemic anaplastic large cell lymphoma (ALCL) but is not currently approved for the treatment of relapsed, transplant eligible HL or for the treatment of other types of NHL. Opdivo is currently not approved for the treatment of lymphoma. About ADCETRIS® (Brentuximab Vedotin) Adcetris is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics' 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 tumor cells. Seattle Genetics and Takeda are jointly developing Adcetris. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize Adcetris in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for Adcetris on a 50:50 basis, except in Japan where Takeda will be solely responsible for development costs. Adcetris has received marketing authorization by regulatory authorities in more than 45 countries. In addition, Adcetris is being evaluated as an investigational agent in more than 30 ongoing clinical trials, including four phase 3 studies, across a variety of CD30-expressing malignances including HL. About OPDIVO (Nivolumab) The U.S. Food and Drug Administration (FDA) approved Opdivo (nivolumab) injection, for intravenous use. Opdivo is a PD-1 blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. 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 the confirmatory trials. Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 50 trials - as monotherapy or in combination with other therapies - in which more than 7,000 patients have been enrolled worldwide. The FDA granted Opdivo Breakthrough Therapy Designation in May 2014 for the treatment of patients with HL after failure of autologous stem cell transplant and brentuximab vedotin. About Lymphoma Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: HL and NHL. NHL is further categorized into indolent (low-grade) or aggressive, including DLBCL. DLBCL is the most common type of NHL. HL is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell generally expresses CD30. About Seattle Genetics Seattle Genetics is a biotechnology company focused on the development and commercialization of innovative antibody-based therapies for the treatment of cancer. Seattle Genetics is leading the field in developing antibody-drug conjugates (ADCs), a technology designed to harness the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. The company's lead product, ADCETRIS® (brentuximab vedotin) is an ADC that, in collaboration with Takeda Pharmaceutical Company Limited, is commercially available for two indications in more than 45 countries, including the U.S., Canada, Japan and members of the European Union. Additionally, ADCETRIS is being evaluated broadly in more than 30 ongoing clinical trials. Seattle Genetics is also advancing a robust pipeline of clinical-stage ADC programs, including SGN (News - Alert)-CD19A, SGN-CD33A, SGN-LIV1A, SGN-CD70A, ASG-22ME and ASG-15ME. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including AbbVie, Agensys (an affiliate of Astellas), Bayer, Genentech, GlaxoSmithKline and Pfizer. More information can be found at www.seattlegenetics.com. About Bristol-Myers Squibb Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bms.com or follow us on Twitter (News - Alert) at http://twitter.com/bmsnews. ADCETRIS (BRENTUXIMAB VEDOTIN) U.S. IMPORTANT SAFETY INFORMATION BOXED WARNING Progressive multifocal leukoencephalopathy (PML): JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS. Contraindication: ADCETRIS is contraindicated with concomitant bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation). Warnings and Precautions:
Adverse Reactions: ADCETRIS was studied as monotherapy in 160 patients in two phase 2 trials. Across both trials, the most common adverse reactions (=20%), regardless of causality, were neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory tract infection, diarrhea, pyrexia, rash, thrombocytopenia, cough and vomiting. Drug Interactions: Concomitant use of strong CYP3A4 inhibitors or inducers, or P-gp inhibitors, has the potential to affect the exposure to monomethyl auristatin E (MMAE). Use in Specific Populations: MMAE exposure and adverse reactions are increased in patients with moderate or severe hepatic impairment or severe renal impairment. Avoid use. For additional important safety information, including Boxed WARNING, please see the full U.S. prescribing information for ADCETRIS at www.seattlegenetics.com. OPDIVO IMPORTANT SAFETY INFORMATION Immune-Mediated Pneumonitis
Immune-Mediated Colitis
Immune-Mediated Hepatitis
Immune-Mediated Nephritis and Renal Dysfunction
Immune-Mediated Hypothyroidism and Hyperthyroidism
Other Immune-Mediated Adverse Reactions
Embryofetal Toxicity
Lactation
Serious Adverse Reactions
Common Adverse Reactions The most common adverse reaction (=20%) reported with OPDIVO was rash (21%). Please see US Full Prescribing Information for OPDIVO. Seattle Genetics Forward-Looking Statement Certain of the statements made in this press release are forward looking, such as those, among others, relating to the future potential therapeutic uses of Adcetris (including in combination with Opdivo) and future clinical and regulatory progress. 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 risks related to adverse clinical results associated with the use of Adcetris or Opdivo (or the combination), the failure of the companies to continue their collaboration or execute on the planned clinical trials or adverse regulatory action. More information about the risks and uncertainties faced by Seattle Genetics is contained in the Company's quarterly report on Form 10-Q for the quarter ended September 30, 2014 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Bristol-Myers Squibb Forward-Looking Statement This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that this investigational combination regimen will receive regulatory approval, or, if approved, that it will become a commercially successful product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2013 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
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