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Japan Ministry of Health, Labor and Welfare Approves Opdivo (nivolumab) for the Treatment of Patients with Unresectable Advanced or Recurrent Gastric Cancer Which Has Progressed After Chemotherapy

On September 22, 2017 Bristol-Myers Squibb Company (NYSE:BMY) reported that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Opdivo (nivolumab) for the treatment of unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy (Press release, Bristol-Myers Squibb, SEP 22, 2017, View Source [SID1234520593]). This approval was based on the Phase 3 study ATTRACTION-2 (ONO-4538-12), in which Opdivo significantly reduced patients’ risk of death by 37% (HR 0.63 [95% CI: 0.51-0.78, p<0.0001]) when compared to placebo. Furthermore, Opdivo demonstrated a greater overall survival rate at 12 months versus placebo, 26.2% (95% CI: 20.7-32.0) and 10.9% (6.2-17.0), respectively. The safety profile of Opdivo in this study was consistent with previously reported studies in solid tumors, and discontinuation rates due to treatment-related adverse events (TRAEs) in the Opdivo and placebo arms were comparable.

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"The approval of Opdivo for advanced or recurrent gastric cancer in Japan offers healthcare providers and patients a much-needed new treatment option, and reinforces our commitment to advance the treatment of cancer through Immuno-Oncology based approaches," said Murdo Gordon, executive vice president and chief commercial officer, Bristol-Myers Squibb. "Opdivo has now been approved for six indications in Japan, underscoring the success of the Ono Pharmaceutical and Bristol-Myers Squibb partnership and our shared commitment to delivering innovative medicines to patients and advancing cancer care in Japan and around the world."

The prevalence of gastric cancer is highest in Asian countries, and it is the second most common cancer diagnosis in Japan, with nearly 134,000 people diagnosed in 2016. While treatment options are available for patients in earlier lines of therapy, nearly all patients with advanced gastric cancer continue to experience disease progression, reinforcing the need for innovative new treatment options.

"I have seen firsthand how patients and their families are negatively impacted by gastric cancer, which in Japan took approximately 50,000 lives last year," said Taroh Satoh, M.D., Frontier Science for Cancer and Chemotherapy, Graduate School of Medicine, Osaka University, Suita, Japan. "It is encouraging that Japanese patients with advanced or recurrent gastric cancer now have an Immuno-Oncology treatment option with the approval of Opdivo, which has shown in clinical trials to improve survival across all patient types, including those whose tumors express PD-L1."

About ATTRACTION-2 (ONO-4538-12)

The approval is based on the results of ATTRACTION-2 (ONO-4538-12), a Phase 3 randomized, double-blind, placebo-controlled clinical trial conducted in Japan, South Korea and Taiwan, evaluating the efficacy and safety of Opdivo in patients with surgically unresectable previously treated advanced or recurrent gastric cancer, including gastroesophageal junction cancer, refractory to or intolerant of at least two chemotherapy regimens. This study was conducted by Ono Pharmaceutical Co. Ltd. of Japan, and data is currently in press with The Lancet.

The ATTRACTION-2 (ONO-4538-12) study evaluated the efficacy of Opdivo using overall survival as the primary endpoint. The secondary endpoints included objective response rate, duration of response, progression-free survival, best overall response, time to response, disease control rate and safety measures.

In the trial, Opdivo 3 mg/kg or placebo was administered every two weeks until disease progression or discontinuation due to unacceptable toxicity. The safety profile of Opdivo was consistent with previously reported studies in solid tumors. TRAEs of any grade and grade 3/4 occurred in 42.7% versus 26.7% and 10.3% versus 4.3% of Opdivo-treated and placebo-treated patients, respectively. The grade 3/4 TRAEs reported in more than two patients were diarrhea, fatigue, decreased appetite, pyrexia, as well as increased aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in the Opdivo group, and fatigue and decreased appetite in the placebo group. The Opdivo and placebo-treated patients had similar rates of TRAEs leading to discontinuation, 2.7% and 2.5%, respectively.

AbbVie and Bristol-Myers Squibb Announce Clinical Research Collaboration to Evaluate a Therapeutic Regimen in Advanced Solid Tumors

On September 22, 2017 AbbVie (NYSE: ABBV) and Bristol-Myers Squibb Company (NYSE: BMY) reported that a clinical trial collaboration to evaluate the combination of AbbVie’s investigational antibody drug conjugate ABBV-399 and Bristol-Myers Squibb’s immunotherapy Opdivo (nivolumab) in c-Met overexpressing non-small cell lung cancer (NSCLC) (Press release, Bristol-Myers Squibb, SEP 22, 2017, View Source [SID1234520592]).

A Phase 1b clinical study is underway that includes evaluating the potential of combining Opdivo, which is designed to alleviate immune suppression, with ABBV-399 to explore the tolerability and potential efficacy of the combination in subjects with advanced c-Met overexpressing NSCLC who failed one prior line of chemotherapy. This study could expand into additional solid tumors in the future.

"Cancer remains one of the most challenging medical conditions for patients and physicians," said Tom Hudson, M.D., vice president, oncology early discovery and development, AbbVie. "Therapeutic advances continue to be achieved every day and we are committed to exploring the potential of our investigational compounds with other approved treatments with the goal to deliver a significant impact to patients."

"We continue to explore the potential of novel combinations of medicines with Opdivo, and AbbVie’s investigational treatments will help evaluate the role of new targets in combination with immunotherapy" said Fouad Namouni, M.D., head of Development, Oncology, Bristol-Myers Squibb. "We look forward to continuing to partner our PD1 with AbbVie’s early- and late-stage assets as a possible treatment option for patients with lung cancer."

AbbVie is the sponsor conducting the trial. Specific terms of the agreement were not disclosed.

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 60 countries, including the United States, the European Union, and Japan. In October 2015, the company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

About ABBV-399

ABBV-399 (telisotuzumab vedotin) is a first-in-class anti-c-Met antibody drug conjugate that targets both c-Met-amplified and c-Met-overexpressing tumors. It is currently being investigated to treat advanced solid tumors. c-Met expression is significantly higher in many solid tumors compared to normal tissue and is a marker of poor prognosis. ABBV-399 is an investigational compound and its safety and efficacy have not been evaluated by the FDA or any other health authority.

Alligator Bioscience to present ADC-1013 intratumoral clinical phase I study results at SITC in November 2017

On September 21, 2019 Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, reported that results from a clinical phase I study of the drug candidate ADC-1013 (JNJ-64457107) will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting, held from 8-12 November 2017 at the Gaylord National Hotel & Convention Center in National Harbor, Maryland, US (Press release, Alligator Bioscience, SEP 21, 2017, View Source [SID1234538685]).

Alligator Bioscience will give both an oral and poster presentation at the SITC (Free SITC Whitepaper) conference with the title: "First-in-human study with intratumoral administration of a CD40 agonistic antibody: preliminary results with ADC-1013/JNJ-64457107 in advanced solid malignancies". The oral presentation will be held at Session Clinical Trials: New Agents, starting at 1:45 p.m. ET (7:45 p.m. CET) on November 10, 2017.

For further information about the program, please visit the conference web site:
View Source

For further information:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 286 44 95
E-mail: [email protected].

This release contains information that Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 8:30 a.m. CEST on 21 September 2017.

Notes to editors

About ADC-1013

ADC-1013 is a drug candidate intended for immunotherapy of different types of cancer. Pre-clinical data have shown that the ADC-1013 antibody effectively activates T-cells, mediated through binding to the co-stimulatory receptor CD40 on dendritic cells. The increased T cell activation enables the immune system to attack the cancer. In addition, since some cancer cells express CD40 on the surface, ADC-1013 may act also through a secondary mechanism of action killing cancer cells directly.

In August 2015, Alligator licensed global development rights for ADC-1013 to Janssen Biotech Inc. In October 2016, Janssen Biotech, Inc. started a second phase I clinical study (ClinicalTrials: NCT02829099). That study is an intravenous dose escalation study with ADC-1013 (JNJ-64457107).

About the ADC-1013 clinical Phase I study

The study to be presented is a multicenter, open-label phase I study in patients with advanced solid tumors evaluating safety and tolerability, pharmacokinetics, immunogenicity, biomarker response and clinical response. The study is a dose-escalation study involving intratumoral and intravenous administration of ADC-1013 at five hospitals in Sweden, Denmark and the UK. The study was performed by Alligator and includes 24 patients and ten different tumor types. For further information, please visit View Source; NCT02379741.

European Commission Approves Bavencio (avelumab) for Metastatic Merkel Cell Carcinoma

On September 21, 2017 Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: PFE) reported that the European Commission (EC) has granted marketing authorization for BAVENCIO (avelumab) as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer (Press release, Pfizer, SEP 21, 2017, View Source [SID1234520590]).[1] BAVENCIO will have marketing authorization in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. BAVENCIO is expected to become commercially available to patients in Europe by prescription within the coming months, with initial launches in Germany and UK expected as early as October 2017.

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"The EC’s decision is significant for BAVENCIO and, more importantly, for European patients living with this very challenging skin cancer," said Luciano Rossetti, M.D., Executive Vice President, Global Head of Research & Development at the biopharma business of Merck KGaA, Darmstadt, Germany, which operates as EMD Serono in the US and Canada. "Our alliance with Pfizer continues to demonstrate the power of working together, and we are grateful to everyone who has helped to bring the first and only approved immunotherapy for mMCC to European patients."

"This European approval further establishes our continued momentum, building on the accelerated approvals BAVENCIO received in the US earlier this year," said Liz Barrett, Global President, Pfizer Oncology. "Importantly, we are now one step closer to our goal of making BAVENCIO available to patients around the world."

Approximately 2,500 Europeans are affected by MCC each year, with metastatic disease diagnosed in 5-12% of patients with MCC. Fewer than 20% of patients with metastatic MCC survive beyond 5 years. [2]-[6]

"Merkel cell carcinoma is a particularly aggressive form of skin cancer with very poor outcomes, especially for those with metastatic disease," said Dirk Schadendorf, MD, Director of Dermatology, University Hospital Essen, Germany. "This approval is a meaningful development for patients and their families suffering from this devastating disease."

The EC approval is based on data from JAVELIN Merkel 200, an international, multicenter, single-arm, open-label, Phase II study; with two parts:[1]

Part A included 88 patients with mMCC whose disease had progressed after at least one chemotherapy treatment. The objective response rate was 33%, with 11% of patients experiencing a complete response and 22% of patients experiencing a partial response. At the time of analysis, tumor responses were durable, with 93% of responses lasting at least 6 months (n=25) and 71% of responses lasting at least 12 months (n=13). Duration of response (DOR) ranged from 2.8 to more than 24.9 months.

Part B, at the time of the data cut-off, included 39 patients with histologically confirmed mMCC who were treatment-naïve to systemic therapy in the metastatic setting. The objective response rate was 62%, with 14% of patients experiencing a complete response (CR) and 48% of patients experiencing a partial response (PR). Sixty-seven percent of patients experienced a progression-free survival (PFS) rate of 3 months.

The safety of avelumab has been evaluated in 1,738 patients with solid tumours including metastatic MCC (N=88) receiving 10 mg/kg every 2 weeks of avelumab in clinical studies.[1]

1,738 patients with solid tumors received 10 mg/kg every 2 weeks. In this patient population, the most common adverse reactions were fatigue (32.4%), nausea (25.1%), diarrhea (18.9%), decreased appetite (18.4%), constipation (18.4%), infusion-related reactions (17.1%), weight decreased (16.6%), and vomiting (16.2%). The most common Grade ≥ 3 adverse reactions were anaemia (6.0%), dyspnoea (3.9%), and abdominal pain (3.0%). Serious adverse reactions were immune-related adverse reactions and infusion-related reaction.

The EC’s decision follows the US Food and Drug Administration’s (FDA) accelerated approval* for BAVENCIO earlier this year for the treatment of mMCC and patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy. BAVENCIO was also granted marketing authorization by Swissmedic on September 05, 2017, in Switzerland for the treatment of patients with mMCC, whose disease has progressed after at least one chemotherapy treatment.

The clinical development program for BAVENCIO, known as JAVELIN, involves at least 30 clinical programs and more than 6,300 patients evaluated across more than 15 different tumor types. In addition to mMCC, these cancers include breast, gastric/gastro-esophageal junction, head and neck, Hodgkin’s lymphoma, emelanoma, mesothelioma, non-small cell lung, ovarian, renal cell carcinoma and urothelial carcinoma.

About Metastatic Merkel Cell Carcinoma
Metastatic MCC is a rare and aggressive disease in which cancer cells form in the top layer of the skin, close to nerve endings.[7]-[8] MCC, which is also known as neuroendocrine carcinoma of the skin or trabecular cancer, often starts in those areas of skin that are most often exposed to the sun, including the head and neck, and arms.[7],[9] Risk factors for MCC include sun exposure and infection with Merkel cell polyomavirus. Caucasian males older than 50 are at increased risk.[7],[9] MCC is often misdiagnosed as other skin cancers and grows at an exponential rate on chronically sun-damaged skin.[9-11] Current treatment options for MCC in Europe include surgery, radiation and chemotherapy.[8] Treatment for metastatic or Stage IV MCC is generally palliative.[8]

Juno Therapeutics Prices $250 Million Follow-on Offering

On September 21, 2017 Juno Therapeutics, Inc. (NASDAQ:JUNO), a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, reported that the pricing of its follow-on public offering of 6,100,000 shares of its common stock at a price to the public of $41.00 per share (Press release, Juno, SEP 21, 2017, View Source;p=RssLanding&cat=news&id=2302262 [SID1234520595]). In addition, Juno has granted the underwriters a 30-day option to purchase up to an additional 915,000 shares of common stock. Juno intends to use the net proceeds of the offering for general corporate purposes and working capital.

The offering is expected to close on September 26, 2017, subject to customary closing conditions. Concurrent with the completion of the follow-on public offering, Juno will complete a private placement of 659,415 shares of its common stock, at a price of $41.00 per share, to a subsidiary of Celgene Corporation. Aggregate gross proceeds from the follow-on public offering and concurrent private placement, before deducting underwriting discounts and commissions, in the case of the follow-on public offering, and expenses payable by Juno will be $277.1 million (or approximately $318.7 million if the underwriters exercise their option to purchase additional shares in full).
Morgan Stanley and J.P. Morgan are acting as joint book-running managers for the offering. Barclays and Leerink Partners are acting as co-lead managers and Wells Fargo Securities, Raymond James and Wedbush PacGrow are acting as co-managers.

A registration statement on Form S-3 relating to the common stock offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on September 20, 2017 and was automatically effective upon filing. The offering is being made only by means of a written prospectus that forms a part of the registration statement. Copies of the final prospectus related to the offering may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014 and J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, or by telephone at (866) 803-9204.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.