On May 17, 2016 Bristol-Myers Squibb Company (NYSE:BMY) reported that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) for the treatment of patients with classical Hodgkin lymphoma (cHL) who have relapsed or progressed after autologous hematopoietic stem cell transplantation (auto-HSCT) and post-transplantation brentuximab vedotin (Press release, Bristol-Myers Squibb Company, MAY 17, 2016, View Source [SID:1234512497]).1

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This accelerated approval is based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. This first approval of a PD-1 inhibitor for cHL patients who have relapsed or progressed after auto-HSCT and post-transplantation brentuximab vedotin is based on a combined analysis of data from the Phase 2 CheckMate -205 and the Phase 1 CheckMate -039 trials.1 Based on this analysis (n=95), Opdivo delivered a high response rate, with an objective response rate (ORR) of 65% (CI 95%: 55-75; 62/95 patients).1 The percentage of patients with a complete response was 7% (CI 95%: 3-15; 7/95 patients), and the percentage of patients with a partial response was 58% (CI 95%: 47-68; 55/95 patients).1 Among responders, the duration of response was maintained over time for a median of 8.7 months (CI 95%: 6.8-NE; range 0.0+, 23.1+).1

Opdivo is associated with the following Warnings and Precautions including immune-mediated: pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, rash, encephalitis, other adverse reactions; infusion reactions; complications of allogeneic HSCT after Opdivo; and embryo-fetal toxicity.1 Please see the Important Safety Information section below.

"As a classical Hodgkin lymphoma patient who has tried multiple therapies, I know firsthand what it’s like to not have a clear next step," said Matt Kludt, a patient enrolled in a nivolumab clinical trial. "When I started on Opdivo, I was hopeful about the potential for this new treatment. Now, I’m proud to be able to say I was one of several patients who have helped contribute to the approval of a new therapy that may offer other patients like me the possibility of a high response rate."

"Today’s approval of Opdivo delivers a transformational and exciting new option for these patients and the hematologists who treat them. By expanding this Immuno-Oncology therapy into a hematologic malignancy, we continue to deliver upon our unwavering commitment to provide treatments that work directly with the body’s immune system for patients who are in need of new options," said Chris Boerner, Head of U.S. Commercial, Bristol-Myers Squibb. "This is our second Immuno-Oncology agent in blood cancer in less than a year for patients impacted by diseases with a deep unmet need. This approval of Opdivo represents how we are continually working towards the goal of helping patients, like Matt, by offering them a new chance in their fight against this disease."

The efficacy of Opdivo in patients (n=95) with cHL after failure of auto-HSCT and post-transplantation brentuximab vedotin was evaluated in the combined analysis from two studies.1 CheckMate -205 is a Phase 2, single-arm, open-label, multicenter, multicohort study.1 The results of this trial will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2016. CheckMate -039 is a Phase 1, open-label, multicenter, dose escalation study.1 In the combined analysis, efficacy was evaluated by ORR, and an additional outcome measure was duration of response. Objective response rate was assessed by an independent radiographic review committee.1

Both studies excluded patients with an Eastern Cooperative Oncology Group (ECOG) performance status of two or higher, autoimmune disease, symptomatic interstitial lung disease, hepatic transaminases more than three times the upper limit of normal (ULN), creatinine clearance less than 40 mL/min, prior allogeneic HSCT or chest irradiation within 24 weeks.1 In addition, both studies required an adjusted diffusion capacity of the lungs for carbon monoxide (DLCO) of more than 60% in patients with prior pulmonary toxicity.1 Patients received 3 mg/kg of single-agent Opdivo administered as an intravenous infusion over 60 minutes every two weeks until disease progression, maximal clinical benefit or unacceptable toxicity.1

The median age was 37 years (range: 18-72), and the majority were male (64%) and white (87%).1 Patients had received a median of five prior systemic regimens (range: 3-15) and received a median of 17 doses of Opdivo (range: 3-48), with a median duration of therapy of 8.3 months (range: 1.9-24 months).1 In adults with cHL who have relapsed or progressed after auto-HSCT and post-transplantation brentuximab vedotin (n=95), Opdivo demonstrated impressive response rates: ORR was 65% (CI 95%: 55-75; 62/95 patients), including a 7% complete response rate (CI 95%: 3-15; 7/95 patients) and a 58% partial response rate (CI 95%: 47-68; 55/95 patients).1 The median time to response was 2.1 months (range: 0.7-5.7).1 Among responders, Opdivo demonstrated an 8.7 month median duration of response (95% CI: 6.8-NE; range 0.0+, 23.1+).1

The safety of Opdivo in cHL was evaluated in 263 adult patients from the CheckMate -205 (n=240) and -039 (n=23) trials.1 Among these patients (safety population: n=263) serious adverse reactions occurred in 21% of patients.1 The most frequent serious adverse reactions reported in ≥1% of patients were infusion-related reaction, pneumonia, pleural effusion, pyrexia, rash and pneumonitis.1 Ten patients died from causes other than disease progression, including 6 who died from complications of allogeneic HSCT.1 In the safety population, 4.2% discontinued treatment due to adverse reactions, and 23% of patients had a dose delay for an adverse reaction.1 In the subset of patients in the efficacy population (n=95), serious adverse reactions occurred in 27% of the patients.1 In CheckMate -205 and -039, among all patients (safety population: n=263) and the subset of patients in the efficacy population (n=95), respectively, the most common adverse reactions (reported in at least 20%) were fatigue (32% and 43%), upper respiratory tract infection (28% and 48%), pyrexia (24% and 35%), diarrhea (23% and 30%), and cough (22% and 35%).1 In the subset of patients in the efficacy population (n=95), the most common adverse reactions also included rash (31%), musculoskeletal pain (27%), pruritus (25%), nausea (23%), arthralgia (21%), and peripheral neuropathy (21%).1

"It is important to have new treatment options for patients with difficult-to-treat diseases who have exhausted the current available options. Because of the unique pathology and biology of classical Hodgkin lymphoma,2 it makes sense from a scientific standpoint to investigate a PD-1 inhibitor," said Anas Younes, M.D., medical oncologist and chief of Lymphoma Service, Memorial Sloan Kettering Cancer Center. "The recent clinical data with Opdivo in patients with classical Hodgkin lymphoma who have relapsed or progressed after auto-HSCT and post-transplantation brentuximab vedotin is encouraging and has the potential to impact our approach to treating these individuals in the future."

About Classical Hodgkin Lymphoma

Hodgkin lymphoma (HL), also known as Hodgkin disease, is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system.3 Approximately 8,500 new cases of HL are estimated to be diagnosed in 2016.3 More than 1,100 deaths from HL are expected this year. According to the Lymphoma Research Foundation, cHL is the most common type of HL, accounting for 95% of cases.4 In this type of HL, cancer cells are called Reed-Sternberg cells, an abnormal type of B lymphocyte.3

On May 17, 2016 Boehringer Ingelheim reported that Olmutinib* (BI 1482694 / HM61713) has been approved in South Korea for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer, who had been previously treated with an EGFR tyrosine kinase inhibitor (TKI) (Press release, Boehringer Ingelheim, MAY 17, 2016, View Source [SID:1234512496]).

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The approval represents a first for regulatory authorities in South Korea and is a major breakthrough for patients. The compound will be distributed in South Korea by Hanmi Pharmaceutical Co. Ltd under the name olmutinib.

This approval is based on the results of the Phase I/II HM-EMSI-101 [NCT01588145 (link is external)] clinical trial which showed promising clinical activity for olmutinib (BI 1482694 / HM61713):1

Among 69 patients evaluable for response, objective response was observed by independent assessment in 62% of patients, including 32 (46%) whose tumour response had been confirmed at the time of data cut-off, 30 June 2015
Disease control rate was 91% by independent assessment
Majority of treatment-related adverse events (AEs) were mild-to-moderate and the most common included diarrhoea, nausea, rash and skin itching
Professor Keunchil Park, Director of Innovative Cancer Medicine Institute (ICMI) at Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea commented, "The approval of olmutinib is a great step forward for lung cancer patients in South Korea. This is an exciting and much needed new treatment option for the majority of EGFR mutation-positive lung cancer patients whose disease has become resistant to first-line TKI therapy, which can be a devastating development."

Olmutinib (BI 1482694 / HM61713) is a novel third-generation, oral, EGFR mutation-specific TKI. It is currently in accelerated development through the ambitious ELUXA clinical trial programme with the aim to submit data and evidence to the US FDA and EU EMA in 2016. The pivotal Phase II trial ELUXA 1 (HM-EMSI-202 [NCT02485652 (link is external)]) is ongoing, enrolling EGFR T790M mutation-positive lung cancer patients who have become resistant to previous TKI treatment.

Dr Jörg Barth, Corporate Senior Vice President, Therapy Area Head Oncology, Boehringer Ingelheim said, "This first approval of olmutinib is an exciting milestone for the compound and we are working diligently to make this novel treatment option globally available to patients and physicians as quickly as possible."

Boehringer Ingelheim and Hanmi Pharmaceutical Co. Ltd signed an exclusive license agreement in 2015 providing the German pharmaceutical company with worldwide exclusive rights except in South Korea, China and Hong Kong. ZAI Lab has secured exclusive rights in China (including Hong Kong and Macau).

Intended audiences
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

Notes to editors
About olmutinib (BI 1482694)
Olmutinib (BI 1482694) is a novel third-generation, orally active, irreversible EGFR mutant-specific TKI. It is currently being investigated for the treatment of patients with advanced and metastatic EGFR mutation-positive NSCLC, whose tumours acquired T790M-mediated resistance to initial EGFR TKI treatment. The compound will be further investigated in the ELUXA pivotal trial programme which will include the initiation of Phase III studies in 2016. The trial programme will research the potential of the compound as a monotherapy and in combination with other potent treatments. Olmutinib (BI 1482694) has demonstrated promising clinical activity, combined with a favourable safety profile in a Phase I/II clinical trial (HM-EMSI-101).1

About lung cancer
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About Boehringer Ingelheim in Oncology
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On May 17, 2016 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) and Celgene Corporation (NASDAQ:CELG) reported an agreement creating a new global strategic collaboration focused on metabolic immuno-oncology, an emerging field of cancer research focused on altering the metabolic state of immune cells to enhance the body’s immune response to cancer (Press release, Agios Pharmaceuticals, MAY 17, 2016, View Source [SID:1234512488]).

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The goal of the collaboration is to discover, develop and commercialize novel therapies based on Agios’ innovative cellular metabolism research platform. Agios will receive an upfront cash payment of $200 million plus the potential for additional payments if certain development and regulatory milestones are achieved. Agios will host a conference call for investors today at 5 p.m. ET.

"The immune system’s ability to attack tumors is highly regulated by cellular metabolism. This emerging discipline of metabolic immuno-oncology has great potential to provide novel insights and targets for cancer immunotherapy in solid and hematologic malignancies," said Rob Hershberg, M.D., Ph.D., chief scientific officer at Celgene. "This strategic agreement combines Agios’ scientific leadership in cellular metabolism with Celgene’s expertise and growing efforts in immuno-oncology and builds upon the extremely productive partnership and working relationship that exist between our two companies."

"Metabolic immuno-oncology is an exciting new area of research for Agios that holds tremendous promise for patients and builds on our strength in cellular metabolism," said David Schenkein, M.D., chief executive officer at Agios. "Following our successful cancer metabolism partnership, we look forward to continuing our work with Celgene in this new field. This strategic alliance will allow Agios to quickly expand our existing research platform into a third core area while leveraging Celgene’s capabilities and broad portfolio of immuno-oncology assets."

Also announced today, the companies modified certain rights from their 2010 collaboration (the "2010 Agreement"). First, Agios, which previously held U.S. rights for AG-120, gained global development and commercialization rights to the program from Celgene. As of August 15, 2016, neither party will have financial or other obligations to each other related to AG-120. There are no other changes to the existing IDH partnership between Agios and Celgene. Second, the companies agreed that rights to two cancer metabolism programs discovered under the 2010 Agreement, including a program focused on MTAP (methylthioadenosine phosphorylase) deleted cancers, will advance under the structure of the new research collaboration outlined below. Following the expiration of the discovery phase of the 2010 Agreement on April 14, 2016, all other cancer metabolism programs discovered at Agios will remain wholly owned by Agios.

New Metabolic Immuno-Oncology Collaboration

Metabolic immuno-oncology is a rapidly evolving scientific area focused on altering the metabolic state of immune cells, or the tumor microenvironment, to enhance the body’s immune response to cancer. There is increasing evidence that metabolism plays an important role in the regulation of immune cells and their response to tumors. The collaboration aims to discover novel metabolic pathways and their modulators that affect the metabolic state of immune cells, which may serve as potent anticancer therapies. In addition, Agios will focus on discovering molecular markers in order to identify patients who are most likely to respond to therapies.

Scope:

Agios will receive an upfront cash payment of $200 million for the initial four-year research term. Celgene has the option to extend the research term for up to two years for a pre-specified amount.
Exploratory research, drug discovery and early development will be led by Agios.
Generally, collaboration programs may be designated by Celgene when preclinical studies begin, and Celgene will then have an option on each program up through Phase 1 dose escalation for at least a $30 million fee.
Economic Terms on Optioned Programs:

For metabolic immuno-oncology programs, Celgene and Agios will enter into a global co-development and co-commercialization agreement with a worldwide 50/50 cost and profit share. Agios is eligible for up to $169 million in clinical and regulatory milestone payments for each program.
The two cancer metabolism programs from the 2010 Agreement, including a program focused on MTAP deleted cancers, are eligible for the same global co-development, co-commercialization and milestone structure described above.
Celgene will have a one-time opportunity to select a metabolic immuno-oncology program for which costs and profits will be shared 65 percent by Celgene and 35 percent by Agios. Agios may also receive up to $209 million in clinical and regulatory milestone payments for this program.
For any inflammation or autoimmune programs that may result from the collaboration, Celgene has the option to enter into an exclusive worldwide license agreement and lead worldwide development and commercialization. For any such licensed products, Agios may receive up to $386 million in clinical, regulatory and commercial milestone payments, as well as double-digit tiered royalties on any net sales.
Development and Commercial Rights:

Agios and Celgene will alternate leadership of all 50/50 programs in the U.S. territory, with Agios making the first program selection.
Celgene will lead ex-U.S. development and commercialization for all programs. Celgene will lead worldwide development and commercialization for the 65/35 program.
Global Rights for AG-120 Transferred to Agios

Agios now has full global development and commercial rights for AG-120, a first-in-class, oral, potent inhibitor of mutant isocitrate dehydrogenase 1 (IDH1). Agios is studying AG-120 in AML in multiple clinical trials, including as a single agent in the relapsed/refractory setting as well as in combination with standard chemotherapy regimens in the frontline setting. Additionally, Agios plans to initiate pivotal trials in AML and is exploring the use of AG-120 in several solid tumors, including cholangiocarcinoma and glioma.

"We are excited to consolidate the full worldwide rights for AG-120, providing us with another wholly owned investigational therapy discovered by Agios scientists to develop and commercialize along with our rare genetic disorders programs," said Dr. Schenkein. "We know that people with AML have limited treatment options today, and we are committed to bringing AG-120 through pivotal development as quickly as possible."

About the Agios-Celgene IDH Program

AG-221 and AG-881 remain part of Agios’ global strategic collaboration with Celgene Corporation, and there are no changes to these programs. Under the terms of the 2010 Agreement, Celgene has worldwide development and commercialization rights for AG-221 (CC-90007). Agios continues to conduct clinical development activities within the AG-221 development program and is eligible to receive up to $95 million in payments on achievement of certain milestones and royalties on any net sales. For AG-881, the companies have a joint worldwide development and 50/50 profit share collaboration, and Agios is eligible to receive regulatory milestone payments of up to $70 million.

On May 17, 2016 Novartis reported changes to focus its Pharmaceuticals Division by creating two business units reporting to the CEO: Novartis Pharmaceuticals and Novartis Oncology (Press release, Novartis, MAY 17, 2016, View Source [SID:1234512486]).

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These business units will form the Innovative Medicines Division at Novartis. The leader of each business will join the Executive Committee of Novartis (ECN) effective July 1, 2016. Paul Hudson will be appointed CEO, Novartis Pharmaceuticals and Bruno Strigini will become CEO, Novartis Oncology. Both will report directly to Joseph Jimenez, CEO of Novartis. With these changes, David Epstein, currently Division Head and CEO, Novartis Pharmaceuticals, has decided to leave Novartis.

The new structure reflects the importance of oncology to Novartis following the successful integration of the oncology assets acquired from GSK. Novartis expects this change to help drive our growth and innovation strategy, with an increased focus and improved execution for both the Novartis Oncology and Novartis Pharmaceuticals business units.

Paul Hudson, currently Executive Vice President, North America and member of the Executive Committee, AstraZeneca, will join Novartis and lead Novartis Pharmaceuticals. Prior to his role in North America, Paul Hudson served as the leader of AstraZeneca’s Japanese business. Novartis Pharmaceuticals will include the franchises Neuroscience, Ophthalmology, Immunology and Dermatology, Respiratory, Cardio-Metabolic and Established Medicines. Mr. Hudson has broad pharmaceutical industry experience and in particular in cardiovascular and immunology, which complement Novartis’ major product launches. He will be based at the global headquarters of the Innovative Medicines Division and the Novartis Pharmaceuticals business unit, which will be in Basel, Switzerland.

Bruno Strigini, currently Head of Novartis Oncology, will lead the Novartis Oncology business unit, comprised of the franchises Oncology and Cell and Gene Therapies. Mr. Strigini joined Novartis in 2014 from Merck & Co. to lead the oncology business and was instrumental in the successful integration of the oncology assets acquired from GSK. He will be based at the global headquarters of the Innovative Medicines Division and the Novartis Oncology business unit which will be in Basel, Switzerland.

David Epstein, currently Division Head and CEO of Novartis Pharmaceuticals, has decided to leave Novartis and explore new challenges from the US. "We would like to thank David for his substantial contribution to the development and growth of Novartis and its people over many years. He built our leading Oncology business and over the last six years has steered our Pharmaceuticals Division through a period of excellence in innovation, execution and improved financial results. Over the course of his career he and his teams have been responsible for leading the development and commercialization of an industry leading number of new medicines including groundbreaking therapies such as Glivec, Gilenya, Cosentyx and Entresto(TM). I want to express my personal appreciation for all David has done for Novartis and patients and wish him continued success," said Joe Jimenez, CEO of Novartis.

From July 1, 2016 Novartis will continue to have three focused, customer-facing divisions: Innovative Medicines (formerly the Novartis Pharmaceuticals division), which will include the Novartis Pharmaceuticals and Novartis Oncology business units; Sandoz, the generics and biosimilar division, which includes the Retail Generics, Anti-Infectives and Biopharmaceuticals franchises; and Alcon, the eye care devices division, which includes the Surgical and Vision Care franchises. The divisions will be supported by Novartis Institutes for BioMedical Research, Global Drug Development and Novartis Operations, which includes Technical Operations and Novartis Business Services.

On May 17, 2016 NantKwest Inc. (Nasdaq:NK), a pioneering, next generation, clinical-stage immunotherapy company focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and inflammatory diseases, reported an update today on the company’s aNK, haNK and taNK clinical programs in a presentation at the Bank of America Merrill Lynch 2016 Health Care Conference in Las Vegas, Nevada (Press release, NantKwest, MAY 17, 2016, http://ir.nantkwest.com/phoenix.zhtml?c=254059&p=RssLanding&cat=news&id=2168882 [SID:1234512456]).

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As part of that presentation, additional details were shared on the following highlighted clinical studies all expected to be initiated in the second half of 2016:

The aNK Phase II clinical study in Merkel cell carcinoma is advancing as planned with an interim data analysis planned for the second half of 2016.
A HER2.taNK Phase I/II clinical study in glioblastoma and breast cancer
A haNK Phase I/II clinical study in breast cancer in combination with trastuzumab (Herceptin)
A haNK Phase I/II clinical study in breast cancer combination with trastuzumab and an adenovirus-based HER2 vaccine
A haNK Phase I/II clinical study in gastric cancer in combination trastuzumab and AMG337, an oral, small molecule MET inhibitor
A haNK Phase I/II clinical study in Ewing’s sarcoma in combination with ganitumab, a human monoclonal antibody against type 1 insulin-like growth factor receptor (IGF1R)
A haNK Phase I/II clinical study in rhabdomyosarcoma in combination with ganitumab and dasatinib
A haNK Phase I/II clinical study in bladder cancer in combination with ALT-803, a novel IL-15 based immune system stimulating agent
Commenting on NantKwest’s clinical progress, Patrick Soon-Shiong, MD, Chairman and CEO remarked, "The complex biology of cancer requires a similarly complex war against cancer that will require combination immunotherapy. We believe NantKwest’s novel, off-the-shelf natural killer cell therapy represents a critical backbone that enables the up regulation of both the innate immune system and the adaptive immune system to begin to successfully fight the war against cancer."

Dr. Soon-Shiong continued, "I am also pleased to announce that with the proceeds from our IPO, the company has rapidly expanded its manufacturing capabilities and with the infrastructure now in place, we are now ready to translate these programs into human clinical studies over the next 6-12 months and look forward to sharing more details on these individual clinical trials over the next few months."

To listen to the presentation in its entirety, the link to the presentation can be found on the NantKwest website at:

https://www.veracast.com/webcasts/baml/healthcare2016/id95107262726.cfm

in the investor relations section of the NantKwest website.