On November 2, 2017 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported financial results for the third quarter ended September 30, 2017 (Press release, Loxo Oncology, NOV 2, 2017, View Source [SID1234521483]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

“In recent months, we have announced meaningful progress across our TRK and RET programs,” said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. “For larotrectinib, an independent review committee has corroborated the striking response rate reported at ASCO (Free ASCO Whitepaper). These data will anchor global regulatory submissions, including a U.S. submission which is on track for late 2017 or early 2018. For RET, study investigators provided a first look at LOXO-292’s potential at the recent World Lung meeting in Japan. The LOXO-292 Phase 1 trial continues to enroll well, and we look forward to providing a study update in 2018.”

Recent Highlights

Larotrectinib

Independent Review Committee Assessment of Larotrectinib Dataset: On October 18, 2017, Loxo Oncology announced top-line overall response rate (ORR) results from the independent review committee assessment of the larotrectinib dataset. Consistent with global written regulatory correspondence, this dataset includes adult and pediatric tropomyosin receptor kinase (TRK) fusion patients enrolled in Loxo Oncology’s Phase 1 adult trial, Phase 2 trial (NAVIGATE), and Phase 1/2 pediatric trial (SCOUT). The dataset is based on the intent to treat (ITT) principle, using the first 55 TRK fusion patients with RECIST-evaluable disease enrolled to the three clinical trials, regardless of prior therapy or tumor tissue diagnostic method. The primary endpoint for the integrated analysis of efficacy is ORR according to the independent review committee assessment, as measured by RECIST v1.1. A key secondary endpoint is ORR according to local investigator assessment, as measured by RECIST v1.1. As of a July 17, 2017 data cut-off date, the ORR was 75% by independent review and 80% by investigator assessment. An overview of the topline data can be found here.
Updated Pediatric Data to Be Presented: Updated pediatric data have been accepted for presentation at the Connective Tissue Oncology Society (CTOS) Annual Meeting on November 10, 2017, and at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Pediatric Cancer Research on December 4-5, 2017. At CTOS, larotrectinib investigators will present an update on the pediatric patients treated with larotrectinib prior to surgical resection. At the AACR (Free AACR Whitepaper) Special Conference on Pediatric Cancer Research, larotrectinib investigators will present updated data from the pediatric dataset last presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting in June.
Data to be Presented at American Society of Hematology (ASH) (Free ASH Whitepaper). At the 59th Annual ASH (Free ASH Whitepaper) Meeting taking place December 9-12, 2017 in Atlanta, GA, Loxo Oncology and academic collaborators will present an abstract regarding TRK fusions in hematologic malignancies.
LOXO-292

Proof-of-Concept Clinical Data in RET Fusion Lung Cancer: On October 18th, LOXO-292 trial investigators presented initial clinical data from the program at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer. This presentation primarily described the first two patients with RET-fusion lung cancer with and without brain metastases treated with LOXO-292. Both patients had disease progression while receiving prior multi-kinase inhibitors. On single agent LOXO-292, both patients achieved RECIST confirmed partial responses and remain on LOXO-292 as of the September 27, 2017 data cut-off of the presentation. In this early, two-patient dataset, LOXO-292 has been well-tolerated, with no adverse events attributed to LOXO-292. Additionally, the presentation included pharmacology evidence that the Phase 1 dose level of 60mg twice daily provides IC90 RET target coverage in patients. The presentation can be viewed here. Loxo Oncology plans to present additional clinical data from this program in the first half of 2018.
Upcoming Milestones

Larotrectinib (TRK)
Medical meeting presentations in the fourth quarter of 2017 include the CTOS Annual Meeting, AACR (Free AACR Whitepaper) Special Conference on Pediatric Cancer Research, and ASH (Free ASH Whitepaper)
Submission of larotrectinib NDA expected by year end 2017 or early 2018
Updated integrated TRK fusion clinical data publication and/or presentation expected in the first half of 2018
LOXO-195 (next-generation TRK)
Clinical data presentation expected in 2018
LOXO-292 (RET)
Clinical data presentation expected in the first half of 2018
LOXO-305 (BTK)
Phase 1 clinical trial initiation expected in 2018
Third Quarter 2017 Financial Results

As of September 30, 2017, Loxo Oncology had aggregate cash, cash equivalents and investments of $405.3 million, compared to $141.8 million as of December 31, 2016.

Research and development expenses were $64.8 million for the third quarter of 2017 compared to $14.2 million for the third quarter of 2016. This increase was primarily due to a non-recurring charge related to the $40.0 million asset acquisition of the BTK inhibitor program from Redx Pharma Plc and Redx Oncology Limited (collectively, “Redx”), expanded larotrectinib development activities including clinical costs and costs related to the companion diagnostics agreement with Roche, as well as additional development expenses related to our other programs. Loxo Oncology also recognized research and development-related stock-based compensation expense of $2.1 million during the third quarter of 2017 compared to $1.6 million for the third quarter of 2016.

Research and development expenses were $109.3 million for the nine months ended September 30, 2017, compared to $34.9 million for the nine months ended September 30, 2016. This increase was primarily due to a non-recurring charge related to the $40.0 million asset acquisition of the BTK inhibitor program from Redx, expanded larotrectinib development activities including clinical costs and costs related to the companion diagnostics agreement with Roche, as well as additional development expenses related our other programs. We also had higher employment costs primarily due to increased headcount. Loxo Oncology also recognized research and development-related stock-based compensation expense of $8.0 million during the nine months ended September 30, 2017, compared to $2.1 million for the nine months ended September 30, 2016.

General and administrative expenses were $9.7 million for the third quarter of 2017 compared to $3.7 million for the third quarter of 2016. The increase was primarily due to increases in preparation activities for the potential commercialization of larotrectinib, headcount and employment costs and general and administrative professional fees. Loxo Oncology also recognized general and administrative-related stock-based compensation expense of $3.1 million during the third quarter 2017 compared to $1.2 million for the third quarter of 2016.

General and administrative expenses were $21.0 million for the nine months ended September 30, 2017, compared to $10.9 million for the nine months ended September 30, 2016. The increase was primarily due to increases in preparation activities for the potential commercialization of larotrectinib, headcount and employment costs and general and administrative professional fees. Loxo Oncology also recognized general and administrative-related stock-based compensation expense of $6.7 million during the nine months ended September 30, 2017, compared to $3.3 million for the nine months ended September 30, 2016.

Net loss was $73.3 million and $128.2 million for the three and nine months ended September 30, 2017, respectively, compared to $17.7 million and $45.2 million for the three and nine months ended September 30, 2016, respectively.

Non-GAAP net loss was $28.1 million and $73.6 million for the three and nine months ended September 30, 2017, respectively, compared to $14.9 million and $39.8 million for the three and nine months ended September 30, 2016, respectively. This non-GAAP net loss measure, more fully described below under “Non-GAAP Financial Measures,” excludes the acquisition of an in process R&D asset and share-based compensation expenses. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

Conference Call Information
Loxo Oncology will host a conference call today at 8:00 a.m. ET to discuss the third quarter 2017 financial results and program updates. To participate in the conference call, please dial (877) 930-8065 (domestic) or (253) 336-8041 (international) and refer to conference ID 78661148. A replay will be available shortly after the conclusion of the call and archived on the company’s website for 30 days following the call.

On November 1, 2017 Calithera Biosciences presented the corporate presentation (Presentation, Calithera Biosciences, NOV 1, 2017, View Source [SID1234535273]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Neurocrine Biosciences has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Neurocrine Biosciences, 2017, NOV 1, 2017, View Source [SID1234521446]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On November 1, 2017 Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, reported financial results for the quarter and nine months ended September 30, 2017, and provided updates on its development programs (Press release, Conatus Pharmaceuticals, NOV 1, 2017, View Source [SID1234521422]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Program Updates
In collaboration with Novartis under terms of the company’s Option, Collaboration and License Agreement with Novartis, which was executed in December 2016, Conatus is conducting four randomized, double-blind, placebo-controlled Phase 2b clinical trials designed to evaluate emricasan treatment in various patient populations, including three EmricasaN, a Caspase inhibitOR, for Evaluation (ENCORE) clinical trials in patients with fibrosis or cirrhosis caused by nonalcoholic steatohepatitis (NASH), and a fourth clinical trial in POLT-HCV-SVR patients:

POLT-HCV-SVR, initiated in the second quarter of 2014, in approximately 60 post-orthotopic liver transplant (POLT) recipients with liver fibrosis or cirrhosis post-transplant as a result of recurrent hepatitis C virus (HCV) infection who have successfully achieved a sustained viral response (SVR) following HCV antiviral therapy, with top-line results expected in the second quarter of 2018;

ENCORE-PH (for Portal Hypertension), initiated in the fourth quarter of 2016, in approximately 240 patients with compensated or early decompensated NASH cirrhosis and severe portal hypertension, with top-line results expected in the second half of 2018 followed by an integrated treatment extension period for clinical outcomes;

ENCORE-NF (for NASH Fibrosis), initiated in the first quarter of 2016, in approximately 330 patients with NASH fibrosis, with top-line results expected in the first half of 2019; and

ENCORE-LF (for Liver Function), initiated in the second quarter of 2017, in approximately 210 patients with decompensated NASH cirrhosis, with top-line results expected in the second half of 2019.
Results from the four ongoing emricasan clinical trials are expected to support the design of Phase 3 clinical efficacy and safety trials.

Pipeline Expansion Plans

In October 2017, the European Medicines Agency (EMA) granted Orphan Drug Designation in the European Union to the company’s pan-caspase inhibitor IDN-7314 for the treatment of primary sclerosing cholangitis (PSC), a disease affecting bile ducts in the liver, which can lead to cirrhosis and liver failure. In June 2017, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation in the United States to IDN-7314 for the treatment of PSC.

These orphan drug designations were based on previously reported data with IDN-7314 demonstrating reduction of relevant biomarkers in two preclinical models of PSC. New results, showing that IDN-7314 markedly diminished inflammasome activation and reduced liver injury in a preclinical model of PSC, were presented in October 2017 at The Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases (AASLD). In a separate study, IDN-7314 reduced biochemical markers in a new acute preclinical model of PSC.

Conatus believes the orphan drug designations, along with the growing body of preclinical data, warrant further evaluation of IDN-7314 as a potential product candidate in PSC as a component of its initial pipeline expansion plans. The company’s ongoing pipeline expansion activities also include:

internal development of new preclinical product candidates leveraging its expertise with the caspase inhibition technology platform, and

evaluation for potential in-licensing or acquisition of external clinical-stage product candidates consistent with its product development and regulatory expertise.
Conatus may pursue the development of product candidates in liver disease and in other related disease areas.

Financial Results
The net loss for the third quarter of 2017 was $4.0 million compared with $6.9 million for the third quarter of 2016. The net loss for the first nine months of 2017 was $13.0 million compared with $20.6 million for the first nine months of 2016.

Total revenues were $9.6 million for the third quarter of 2017 and $26.6 million for the first nine months of 2017, compared with $0.0 million for the comparable periods in 2016. Total revenues for both periods in 2017 consisted of collaboration revenue related to the Option, Collaboration and License Agreement with Novartis.

Research and development expenses were $11.2 million for the third quarter of 2017 compared with $4.8 million for the third quarter of 2016. Research and development expenses were $32.3 million for the first nine months of 2017 compared with $13.8 million for the first nine months of 2016. The increases in research and development expenses were primarily due to the ramp up of our ENCORE-NF, ENCORE-PH and ENCORE-LF clinical trials.

General and administrative expenses were $2.4 million for the third quarter of 2017 compared with $2.1 million for the third quarter of 2016. General and administrative expenses were $7.4 million for the first nine months of 2017 compared with $6.9 million for the first nine months of 2016. The increases in general and administrative expenses were primarily due to higher personnel costs and professional fees.

Cash, cash equivalents and marketable securities were $85.2 million at September 30, 2017, compared with $77.0 million at December 31, 2016. Based primarily on lower than expected spending on in-licensing and internal pipeline development, the company is now projecting a year-end 2017 balance of between $70 million and $75 million. The company believes its current and forecasted financial resources are sufficient to maintain operations and ongoing emricasan clinical development activities through the end of 2019, as well as to fund anticipated pipeline expansion activities.

Conference Call and Audio Webcast
Conatus will host a conference call and audio webcast at 4:30 p.m. Eastern Time today to discuss the financial results and provide a corporate update. To access the conference call, please dial 877-312-5857 (domestic) or 970-315-0455 (international) at least five minutes prior to the start time and refer to conference ID 99505370. A live and archived audio webcast of the call will also be available in the Investors section of the Conatus website at www.conatuspharma.com.

On November 1, 2017 Seattle Genetics, Inc. (Nasdaq: SGEN) reported that 18 abstracts featuring data from the broad ADCETRIS (brentuximab vedotin) development program have been accepted for presentation, including a plenary presentation, at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place from December 9-12, 2017 in Atlanta, Georgia (Press release, Seattle Genetics, NOV 1, 2017, View Source [SID1234521404]). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of Hodgkin lymphoma cells and several types of non-Hodgkin lymphoma. ADCETRIS is being evaluated globally as the foundation of care for CD30-expressing lymphomas in more than 70 corporate- and investigator-sponsored clinical trials.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Data accepted for presentation at the ASH (Free ASH Whitepaper) Annual Meeting include the following:

Data from the phase 3 ECHELON-1 clinical trial evaluating ADCETRIS in combination with chemotherapy in frontline advanced classical Hodgkin lymphoma patients will be featured in the Plenary Scientific Session on Sunday, December 10, 2017 from 2:00 – 4:00 p.m. ET. Based on the positive results from the ECHELON-1 trial, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to ADCETRIS in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma. Seattle Genetics expects to submit in the fourth quarter of 2017 a supplemental Biologics License Application (BLA) to the FDA for approval of ADCETRIS in frontline advanced classical Hodgkin lymphoma.
Numerous oral and poster presentations highlighting additional progress within the ADCETRIS development program including:
Updated durability results from the phase 3 ALCANZA clinical trial in patients with CD30-expressing mycosis fungoides and primary cutaneous anaplastic large cell lymphoma, the most common subtypes of cutaneous T-cell lymphoma (CTCL). Based on the positive results from the ALCANZA trial, a supplemental BLA for ADCETRIS in CTCL was accepted for filing by the FDA. The FDA granted Priority Review for the application and the Prescription Drug User Fee Act (PDUFA) target action date is December 16, 2017. ADCETRIS previously received FDA Breakthrough Therapy Designation in this setting.
Updated results from a phase 1/2 study of ADCETRIS in combination with Opdivo (nivolumab) among patients with relapsed or refractory Hodgkin lymphoma
Final five-year survival and durability results in patients with CD30-expressing peripheral T-cell lymphomas who received ADCETRIS with cyclophosphamide, hydroxydaunorubicin, and prednisone (CHP) as frontline therapy
“At this year’s ASH (Free ASH Whitepaper) Annual Meeting, we will present data from 18 abstracts, highlighting several ADCETRIS clinical program advancements that support our plans to establish ADCETRIS as the foundation of care for CD30-expressing lymphomas,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “Importantly, the results of the phase 3 ECHELON-1 clinical trial evaluating ADCETRIS combination therapy in frontline advanced Hodgkin lymphoma patients was selected from over 6,000 abstracts submitted to be featured in the Plenary Scientific Session. These data are the basis for our planned supplemental biologics license application to the FDA requesting approval of ADCETRIS in this setting. The breadth of data being presented with ADCETRIS in CD30-expressing lymphomas demonstrates the power of antibody-drug conjugates with a goal of improving patient outcomes.”

ADCETRIS is currently not approved for the treatment of frontline Hodgkin lymphoma, CTCL, or as combination therapy for Hodgkin lymphoma or non-Hodgkin lymphoma.

Multiple corporate and investigator presentations will be featured at ASH (Free ASH Whitepaper). Abstracts can be found at www.hematology.org and include the following:

Saturday, December 9, 2017

Updated analyses of the international, open-label, randomized, phase 3 ALCANZA study: longer-term evidence for superiority of brentuximab vedotin versus methotrexate or bexarotene for CD30-positive cutaneous T-cell lymphoma (Abstract #1509, poster presentation)
A pilot study of weekly brentuximab vedotin in patients with CD30+ malignancies resistant to every 3 week brentuximab vedotin (Abstract #1528, poster presentation)
Brentuximab vedotin with R-CHP chemotherapy as frontline treatment for patients with CD30 positive primary mediastinal large B-cell, diffuse large B-cell, and grey zone lymphomas: results of a phase I/II multisite trial (Abstract #191, oral presentation at 3:00 p.m. ET)
Patient-reported distress in Hodgkin lymphoma patients on active therapy vs. long-term survivors (Abstract #2173, poster presentation)
Real world clinical and economic burden of patients with Hodgkin lymphoma who fail frontline therapy in the US (Abstract #2128, poster presentation)
Sunday, December 10, 2017

Brentuximab vedotin plus doxorubicin, vinblastine, dacarbazine (A+AVD) as frontline therapy demonstrates superior modified progression-free survival versus ABVD in patients with previously untreated stage III or IV Hodgkin lymphoma (HL): the phase 3 ECHELON-1 study (Plenary Scientific Session presentation from 2:00 – 4:00 p.m. ET)
Five-year survival results: frontline brentuximab vedotin in combination with CHP in patients with CD30-expressing peripheral T-cell lymphomas (Abstract #2790, poster presentation)
Radiographic and high-throughput sequencing (HTS)-based response assessment after brentuximab vedotin plus ifosfamide, carboplatin, and etoposide (ICE) for relapsed/refractory classical Hodgkin lymphoma: updated results of a phase I/II trial (Abstract #2806, poster presentation)
Patient and physician preferences for front-line treatment of advanced stage Hodgkin lymphoma (Abstract #4082, poster presentation)
Changes in serum TARC predict PET response among pediatric patients with relapsed or refractory Hodgkin lymphoma treated with brentuximab vedotin and gemcitabine: a report from the Children’s Oncology Group (Abstract #2798, poster presentation)
Phase 2 Study of Brentuximab Vedotin in Patients with Advanced Systemic Mastocytosis (Abstract #2909, poster presentation)
Monday, December 11, 2017

Results from a phase 1/2 study of brentuximab vedotin in combination with nivolumab in patients with relapsed or refractory Hodgkin lymphoma (Abstract #649, oral presentation at 10:30 a.m. ET)
Sequential brentuximab vedotin before and after adriamycin, vinblastine, and dacarbazine (A-VAD-A) for older patients with untreated Hodgkin lymphoma: final results from a multicenter phase II study (Abstract #733, oral presentation at 2:45 p.m. ET)
About ADCETRIS

ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30 and is being evaluated broadly in more than 70 clinical trials, including four phase 3 studies: the ECHELON-1 trial in frontline classical Hodgkin lymphoma from which positive top-line results were recently reported and the FDA granted Breakthrough Therapy Designation in this setting, the ongoing ECHELON-2 trial in frontline mature T-cell lymphomas, the completed ALCANZA trial in cutaneous T-cell lymphoma that supported the supplemental BLA with a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2017, and the recently initiated CHECKMATE 812 trial of ADCETRIS in combination with Opdivo (nivolumab) for relapsed/refractory Hodgkin lymphoma.

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.

ADCETRIS for intravenous injection has received FDA approval for three indications: (1) regular approval for the treatment of patients with classical Hodgkin lymphoma after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (2) regular approval for the treatment of classical Hodgkin lymphoma patients at high risk of relapse or progression as post-auto-HSCT consolidation, and (3) accelerated approval for the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen. The sALCL indication is approved under accelerated approval based on overall response rate. Continued approval for the sALCL indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-ASCT consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression.

ADCETRIS was granted conditional marketing authorization by the European Commission in October 2012 for two indications: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) the treatment of adult patients with relapsed or refractory sALCL. The European Commission extended the current conditional marketing authorization of ADCETRIS and approved ADCETRIS for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT.

ADCETRIS has received marketing authorization by regulatory authorities in 68 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See important safety information below.

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 is solely responsible for development costs.