On November 29, 2017 Bristol-Myers Squibb Company (NYSE: BMY) reported 33 presentations from Company-sponsored studies, collaborations and investigator-sponsored research evaluating Opdivo (nivolumab), Sprycel (dasatinib) and Empliciti (elotuzumab), will be featured at the 59th Annual Meeting & Exposition of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Atlanta, Ga. from December 9-12 (Press release, Bristol-Myers Squibb, NOV 29, 2017, View Source [SID1234522302]).

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Presentations across tumor types, including Hodgkin and non-Hodgkin lymphomas, leukemia and multiple myeloma, reinforce Bristol-Myers Squibb’s deep expertise in hematologic cancers and commitment to advancing science to improve patient outcomes.

Data to be presented by Bristol-Myers Squibb include:

Classical and Non-Hodgkin Lymphoma

Results from a phase 1/2 study of brentuximab vedotin in combination with nivolumab in patients with relapsed or refractory Hodgkin lymphoma
Author: A. Herrera
Abstract: #649
Oral Session: 624. Hodgkin Lymphoma and T/NK Cell-Lymphoma-Clinical Studies: Hodgkin Lymphoma Immunotherapy studies; nodular lymphocyte predominant Hodgkin Lymphoma clinical studies
Monday, December 11, 10:30 AM EST, Georgia World Congress Center, Building A, Level 4, Marcus Auditorium
Nivolumab treatment beyond investigator-assessed progression: outcomes in patients with relapsed/refractory classical Hodgkin lymphoma from the phase 2 CheckMate -205 study
Author: J. Cohen
Abstract: #650
Oral Session: 624. Hodgkin Lymphoma and T/NK Cell-Lymphoma-Clinical Studies: Hodgkin Lymphoma Immunotherapy studies; nodular lymphocyte predominant Hodgkin Lymphoma clinical studies
Monday, December 11, 10:45 AM EST, Georgia World Congress Center, Building A, Level 4, Marcus Auditorium
Nivolumab for newly diagnosed advanced-stage classical Hodgkin lymphoma: results from the phase 2 CheckMate -205 study
Author: R. Ramchandren
Abstract: #651
Oral Session: 624. Hodgkin Lymphoma and T/NK Cell-Lymphoma-Clinical Studies: Hodgkin Lymphoma Immunotherapy studies; nodular lymphocyte predominant Hodgkin Lymphoma clinical studies
Monday, December 11, 11 AM EST, Georgia World Congress Center, Building A, Level 4, Marcus Auditorium
Safety and efficacy of the combination of ibrutinib and nivolumab in patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia
Author: A. Younes
Abstract: #833
Oral Session: 642. CLL: Therapy, excluding Transplantation: New Agents, Infections and PET/CT
Monday, December 11, 5:30 PM EST, Georgia World Congress Center, Building B, Level 5, Murphy BR 3-4
Expression of major histocompatibility complex class II, but not MHC class I, predicts outcome in patients with classical Hodgkin lymphoma treated with nivolumab (programmed death-1 [PD-1] blockade)
Author: M. Roemer
Abstract: #1450
Poster Session: 621. Lymphoma-Genetic/Epigenetic Biology: Poster I
Saturday, December 9, 5:30-7:30 PM EST, Georgia World Congress Center, Building A, Level 1, Hall A2
Cost effectiveness of nivolumab for the treatment of relapsed/refractory classical Hodgkin lymphoma after failure of autologous stem cell transplantation and treatment with brentuximab vedotin treatment in Australia
Author: M. Tan
Abstract: #2166
Poster Session: 904. Outcomes Research-Malignant Conditions: Poster I
Saturday, December 9, 5:30-7:30 PM EST, Georgia World Congress Center, Building A, Level 1, Hall A2
Effect of nivolumab on patient-reported outcomes in patients with relapsed/refractory classical Hodgkin lymphoma after autologous transplantation: results from the multicohort phase 2 CheckMate -205 study
Author: A. Engert
Abstract: #3441
Poster Session: 904. Outcomes Research-Malignant Conditions: Poster II
Sunday, December 10, 6-8 PM EST, Georgia World Congress Center, Building A, Level 1, Hall A2
Economic burden in U.S. patients with relapsed or refractory classical Hodgkin lymphoma treated with brentuximab vedotin or chemotherapy after failure of autologous hematopoietic cell transplantation
Author: C. Chen
Abstract: #4705
Poster Session: 902. Health Services Research-Malignant Conditions: Poster III
Monday, December 11, 6-8 PM EST, Georgia World Congress Center, Building A, Level 1, Hall A2
Multiple Myeloma

Elotuzumab plus lenalidomide/dexamethasone vs Ld in patients with newly diagnosed multiple myeloma: phase 2, randomized, open-label study in Japan
Author: N. Takezako
Abstract: #434
Oral Session: 653. Myeloma: Therapy, excluding Transplantation: Upfront Therapy for Multiple Myeloma: Induction and Maintenance
Sunday, December 10, 12:15 PM EST, Georgia World Congress Center, Building C, Level 1, Hall C4
Duration of treatment of multiple myeloma regimens in patients with relapsed or refractory multiple myeloma: findings in U.S. clinical practice settings
Author: R. Potluri
Abstract: #1844
Poster Session: 653. Myeloma: Therapy, excluding Transplantation: Poster I
Saturday, December 9, 5:30-7:30 PM EST, Georgia World Congress Center, Building A, Level 1, Hall A2
Treatment sequencing patterns observed in patients treated initially with lenalidomide/dexamethasone combination as frontline multiple myeloma therapy
Author: C. Chen
Abstract: #3127
Poster Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Sunday, December 10, 6-8 PM EST, Georgia World Congress Center, Building A, Level 1, Hall A2
Treatment patterns and associated outcomes in patients with relapsed or refractory multiple myeloma in the U.S. and non-U.S. countries: findings from PREAMBLE
Author: R. Vij
Abstract: #3123
Poster Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Sunday, December 10, 6-8 PM EST, Georgia World Congress Center, Building A, Level 1, Hall A2
Healthcare resource utilization and costs associated with different treatment modalities of relapsed/refractory multiple myeloma patients in the U.S.: findings from PREAMBLE
Author: D. Kuter
Abstract: #3157
Poster Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Sunday, December 10, 6-8 PM EST, Georgia World Congress Center, Building A, Level 1, Hall A2
Leukemia

CA180-372: An international collaborative phase 2 trial of dasatinib and chemotherapy in pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia
Author: S. Hunger
Abstract #98
Oral Session: 612. Acute Lymphoblastic Leukemia: Clinical Studies: Advances in the Treatment of ALL
Saturday, December 9, 9:45 AM EST, Georgia World Congress Center, Building C, Level 2, Hall C211-C213
Dasatinib discontinuation in patients with chronic-phase chronic myeloid leukemia and stable deep molecular response
Author: N. Shah
Abstract: #314
Oral Session: 632: Chronic Myeloid Leukemia: Therapy: Treatment Discontinuation, Dose Reduction and Prognostic Indicators
Sunday, December 10, 7:45 AM EST, Georgia World Congress Center, Building A, Level 4, Marcus Auditorium
Impact of earlier vs. later monitoring on disease progression and economic outcomes among patients with chronic myeloid leukemia in the real-world setting
Author: E. Jabbour
Abstract: #2175
Poster Session: 904. Outcomes Research—Malignant Conditions: Poster I
Saturday, December 9, 5:30-7:30 PM EST, Georgia World Congress Center, Building A, Level 1, Hall A2
Cytogenetic and molecular responses by two years in SIMPLICITY, an observational study of chronic-phase chronic myeloid leukemia patients in routine clinical practice
Author: J. Cortes
Abstract: #2894
Poster Session: 632. Chronic Myeloid Leukemia: Therapy: Poster II
Sunday, December 10, 6-8 PM EST, Georgia World Congress Center, Building A, Level 1, Hall A2
Economic modeling of the potential impact of chronic myeloid leukemia monitoring on healthcare costs
Author: E. Jabbour
Abstract: #3378
Poster Session: 902. Health Services Research—Malignant Conditions: Poster II
Sunday, December 10, 6-8 PM EST, Georgia World Congress Center, Building A, Level 1, Hall A2

On November 29, 2017 Actinium Pharmaceuticals, Inc. (NYSE American:ATNM) ("Actinium" or "the Company"), a clinical-stage biopharmaceutical company focused on developing and commercializing targeted therapies for safer myeloablation and conditioning of the bone marrow prior to a bone marrow transplant and for the targeting and killing of cancer cells, highlighted its planned activity at the upcoming 59th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting & Exposition being held December 9 – 12, 2017 in Atlanta, Georgia (Press release, Actinium Pharmaceuticals, NOV 29, 2017, View Source [SID1234522298]). Actinium’s Actimab-A Phase 2 trial will be highlighted in a poster presentation that will discuss results to date from the multi-center, open label Phase 2 trial that has been designed to assess overall response rates of patients receiving fractionated doses of Actimab-A. Patients enrolled in this trial are newly diagnosed with acute myeloid leukemia (AML) that are over the age of 60. Preliminary results from the Company’s recently announced Actinium Warhead Enabling (AWE) Technology Program will be presented by poster. The results contrast the superior celling killing power of Actinium-225 labeled daratumumab versus the unlabeled antibody, which is a blockbuster therapy targeting CD38 for patients with multiple myeloma marketed by Johnson & Johnson. In addition, experimental results supporting targeting of the CD33 antigen in multiple myeloma patients that provides the scientific rational for the Actimab-M trial will also be presented in an abstract.

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Details of Actinium’s abstract poster presentations are as follows:

Title: A Phase 2 Study of Actinium-225 (225Ac)-Lintuzumab in Older Patients with Previously Untreated Acute Myeloid Leukemia (AML) Unfit for Intensive Chemotherapy
Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster II
Date: Sunday, December 10, 2017
Time: 6:00PM-8:00PM
Location: Bldg A, Lvl 1, Hall A2 (Georgia World Congress Center)

Title: Actinium Labeled Daratumumab Demonstrates Enhanced Killing of Multiple Myeloma Cells over Naked Daratumumab
Session: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Poster III
Date: Monday, December 11, 2017
Time: 6:00PM-8:00PM
Location: Bldg A, Lvl 1, Hall A2 (Georgia World Congress Center)

An online abstract has been accepted highlighting experimental results supporting the rationale for targeting CD33 in patients with multiple myeloma, which will be accessible on December 8, 2017. Details for the online abstract are as follows:

Title: CD33 Is Expressed in a Significant Subset of Multiple Myeloma Patients in the US and May Represent a Viable Therapeutic Target
Session: 651. Myeloma: Biology and Pathophysiology, excluding therapy

"This year’s American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting & Exposition represents an inflection point for Actinium’s clinical development and research progress," said Dr. Mark Berger, Actinium’s Chief Medical Officer. "As shown in our abstract, Actimab-A generated strong response rates exceeding 50% in a tremendously difficult to treat AML patient population as a single agent and I look forward to the detailed results being presented at ASH (Free ASH Whitepaper) via our poster presentation. In addition to its strong efficacy, we have gained further insights into Actimab-A’s safety profile, namely its minimal extramedullary toxicities. I believe that this strength of Actimab-A will allow us to utilize Actimab-A in additional indications where patients have high unmet needs that can be addressed with strong single agent efficacy, a unique mechanism of action and robust myelosuppressive capabilities with minimal effects outside of the hematopoietic system."

Key Highlights of Actinium’s Activities Include:

Poster presentation highlighting data from Actinium’s Phase 2 trial of Actimab-A, a CD33 targeting agent, in patients newly diagnosed with AML unfit for intensive chemotherapy
Poster presentation highlighting new data from Actinium’s recently announced AWE Technology Platform
Abstract supporting the targeting of CD33 in multiple myeloma and the scientific rationale for Actimab-M
The Clinical Advisory Board will review the progress of the multi-center, Phase 2 trial of Actimab-A, Actinium’s CD33 targeting antibody radio-conjugate for AML
The Scientific Advisory Board will review the progress of the Phase 3 Iomab-B SIERRA trial for patients 55 and older with relapsed and refractory AML
Meeting with investigators from the 15 participating SIERRA clinical trial sites
Sandesh Seth, Actinium’s Chairman and CEO said, "This year’s ASH (Free ASH Whitepaper) annual meeting will be the most active in the Company’s history and will showcase Actinium’s strengthened capabilities in clinical development and research and development. I am proud of our team’s ability to leverage our AWE technology platform and drive our drug development strategically. As a result, we have demonstrated the potential of utilizing Actinium-225 with established commercial products as a means of developing biobetters, which we will be offering to potential biopharmaceutical partners. We have also identified via our clinical results additional strengths of our CD33 program. We believe that these findings offer additional clinical opportunities where we can leverage our strengths, experience and know-how in the field of bone marrow transplant and targeted alpha particle therapy. We look forward to the ASH (Free ASH Whitepaper) annual meeting where our clinical and experimental work on Actimab-A, Actimab-M and the AWE platform will be showcased via the posters and publications, and also in our meetings with the scientific and business community. In addition, we look forward to revealing new clinical opportunities at our December 5th Webinar."

About Actimab-A

Actimab-A, Actinium’s most advanced alpha-particle therapy product candidate, is currently in a 53-patient, multicenter Phase 2 trial for patients newly diagnosed with AML age 60 and above that are ineligible for standard induction chemotherapy. Actimab-A is being developed as a first-line therapy and is a monotherapy that is administered via two 15-minute injections that are given 7 days apart. Actimab-A targets CD33, a protein abundantly expressed on the surface of AML cells via the monoclonal antibody, HuM195, which carries the potent cytotoxic radioisotope actinium-225 to the AML cancer cells. Actinium-225 gives off high-energy alpha particles as it decays, which kill cancer cells and as actinium-225 decays it produces a series of daughter atoms, each of which gives off its own alpha particle, increasing the chances that the cancer cell will be destroyed. Actimab-A is a second-generation therapy from the Company’s HuM195-Alpha program, which was developed at Memorial Sloan Kettering Cancer Center and has now been studied in almost 90 patients in four clinical trials. Actimab-A has been granted Orphan Drug Designation for newly diagnosed AML in patients 60 and above by the U.S. Food and Drug Administration.

About Actimab-M

Actimab-M is being investigated in patients with refractory multiple myeloma. Multiple myeloma is a currently incurable cancer of plasma cells, which are white blood cells that produce antibodies. Actimab-M is currently being studied in a Phase 1 dose escalation study in up to 12 patients that is designed to establish safety, maximum tolerable dose and proof of concept. Actimab-M consists of actinium-225, an alpha-emitting radioisotope coupled to the anti-CD33 monoclonal antibody, HuM-195. CD33 has been shown to be expressed on myeloma plasmocytes in 25% to 35% of multiple myeloma patients and has also shown to be correlated with poorer outcomes.

About Our AWE Technology Platform

The Actinium Warhead Enabling (AWE) Technology Platform enables a highly potent and selective form of targeted therapy that combines the powerful alpha-emitting radioisotope actinium-225 with targeting agents, which are designed to seek out cancer cells in the body that express particular markers. Actinium-225 emits significant alpha radiation making it a potent treatment modality against targeted cancer cells while limiting damage to healthy tissues as its radiation travels extremely short distances in the body. When labeled to targeting agents, actinium-225 can be delivered directly to cancer cells where the high linear energy transfer resulting from the emission of alpha particles results in irreparable DNA double stranded breaks and ultimately cancer cell death. Despite this superior cell killing power, actinium-225 when delivered in a targeted manner is sparing of the surrounding environment in the body due to the short path length of its alpha-particle radiation and can result in a superior safety profile. Actinium Pharmaceuticals owns or has licensed the rights to several issued and pending patents that pertain to its AWE Technology Platform including technology to manufacture actinium-225 in a cyclotron. In addition, the Company obtains actinium-225 from various sources such as the U.S. Department of Energy at Oak Ridge National Laboratories and has developed considerable know-how, expertise and validated processes related to production of radioimmunoconjugates, management of the supply chain and dealing with various regulatory bodies. The AWE Technology Platform can be utilized to potentially improve the cell-killing power of targeting agents such as antibodies, peptides, Fab fragments, nanobodies etc. via labeling with actinium-225. In addition to increased efficacy, these actinium-225 enhanced targeting agents can offer optimized dosing or administration and in the case of approved targeting agents provide an opportunity to extend intellectual property protection by the creation of "Biobetters" or improved versions of the approved agent. The Company’s Actinium Warhead Enabling (AWE) Program can be accessed by biopharmaceutical companies that are interested in creating Biobetters through the utilization of the AWE Platform Technology. To learn more about the AWE Technology Platform or the AWE Program please contact Keisha Thomas, Ph.D., Corporate Development at [email protected].

On November 28, 2017 SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company delivering innovative anti-infective therapies for difficult-to-treat and often life-threatening infections, reported that the Company will participate in the following upcoming investor conferences (Press release, Scynexis, NOV 28, 2017, View Source [SID1234522275]):

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Know more, wherever you are:
Latest on SCYNEXIS’s Cancer Pipeline, book your free 1stOncology demo here.

The Global Mizuho Investor Conference (MIC) NY at the Lotte New York Palace Hotel on Monday, December 4, 2017.
The Guggenheim Securities 5th Annual Boston Healthcare Conference at the InterContinental Boston on Wednesday, December 13, 2017.

On November 28, 2017 Aptevo Therapeutics Inc. (Nasdaq:APVO), a biotechnology company focused on developing novel oncology and hematology therapeutics, reported recent developments related to the Company’s novel ADAPTIR bispecific antibody platform, including the planned commencement of a Phase 2 clinical evaluation of its monospecific antibody candidate, otlertuzumab, in a new indication – peripheral T-cell lymphoma (PTCL), scheduled to begin in the fourth quarter of 2017.

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In addition, Aptevo announced that the Company expects to file 2 Investigational New Drug (IND) applications in 2018 for 2 bispecific antibody candidates, APVO436, being developed for the treatment of acute myeloid leukemia (AML), and APVO210, being developed for the treatment of autoimmune and inflammatory diseases.

"We continue to make solid progress advancing our ADAPTIR portfolio with the expansion of our otlertuzumab clinical development program to include a new indication in PTCL, as well as planned IND filings for two new ADAPTIR candidates in 2018," said Scott Stromatt, Chief Medical Officer. "Recently, intriguing evidence has been reported on the overexpression of CD37 on T-cell malignancies, suggesting a potential role for otlertuzumab in an attractive, orphan drug-eligible indication with high unmet medical need. Based on these developments, Aptevo has decided to expand its existing Phase 2 clinical protocol to evaluate otlertuzumab in PTCL and discontinue enrollment in the ongoing cohorts evaluating otlertuzumab in CLL with the intention of continuing to explore partnership opportunities for Phase 3 development of otlertuzumab in CLL. With clinical proof-of-concept data demonstrating the efficacy and tolerability of otlertuzumab in previous combination studies, we believe that evidence of a clinical effect in PTCL could open up a promising new market opportunity for otlertuzumab in the treatment of T-cell malignancies where there is a significant need for safe and effective new treatments."

"Aptevo is quickly establishing an impressive portfolio of novel immunotherapeutics with a number of candidates advancing, or poised to advance, into the clinic over the next 12 to18 months," continued Dr. Stromatt. "We believe that bispecifics represent the next frontier in antibody therapeutics and are encouraged by Aptevo’s rapid progress in this field. Importantly, the enhancements we have made to our next generation ADAPTIR platform are differentiated from other bispecific platforms, allowing us to assemble bispecific molecules that possess desired antibody-like features, including: efficient manufacturing properties, extended half-life, improved potency, increased stability and the potential for reduced toxicity. We look forward to data read-outs next year from our current clinical candidates, APVO414 and otlertuzumab, and to further expanding our portfolio of clinical candidates."

About the Phase 2 Otlertuzumab Study
The Phase 2 study is an open-label, proof-of-concept evaluation of the safety and efficacy of otlertuzumab in combination with bendamustine in patients with relapsed or refractory peripheral T-cell lymphomas (PTCL). Up to 24 patients will be enrolled in the study. The primary endpoint is response rate, evaluable by the 2017 International Working Group consensus response evaluation criteria in lymphoma (RECIL 2017).

About Otlertuzumab
Otlertuzumab is a monospecific antibody targeting CD37 that was built on Aptevo’s ADAPTIR modular protein therapeutic platform. CD37 is a member of the tetraspanin superfamily of molecules and is expressed on the surface of normal and transformed B cells, and also recently discovered to be present on the surface of T-cell lymphomas.

On November 28, 2017 Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: PFE) reported that the Phase III JAVELIN Gastric 300 trial did not meet its primary endpoint of superior overall survival (OS) with single-agent avelumab* compared with physician’s choice of chemotherapy (Press release, Pfizer, NOV 28, 2017, View Source [SID1234522288]). The trial investigated avelumab as a third-line treatment for unresectable, recurrent or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma patients whose disease progressed following two prior therapeutic regimens, regardless of programmed death ligand-1 (PD-L1) expression. The safety profile of avelumab was consistent with that observed in the overall JAVELIN clinical development program.

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"Gastric cancer in the third-line setting is a particularly hard-to-treat and heterogeneous disease, and importantly, this was the first trial conducted with a checkpoint inhibitor compared to an active chemotherapy comparator rather than placebo in a global patient population," 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. "Data from this study will provide valuable information for physicians treating this late stage disease. We remain committed to our ongoing gastric cancer program with avelumab including the JAVELIN Gastric 100 study in the first-line switch maintenance setting."

"Gastric cancer is a leading cause of cancer death globally with clear unmet needs, and the results provide important insights as we continue to investigate the role of avelumab for the treatment of gastric cancer," said Chris Boshoff, M.D., Ph.D., Senior Vice President and Head of Immuno-Oncology, Early Development and Translational Oncology, Pfizer Global Product Development. "With approvals for two cancers in 2017, our companies have made tremendous progress with avelumab on behalf of patients this year, and we are confident that our broad clinical development program in both monotherapy and combinations across a range of cancers will continue to bring new potential treatment options to patients."

The JAVELIN Gastric 300 data will be further examined in an effort to better understand the results and will also be submitted for presentation at an upcoming medical congress. The outcome of JAVELIN Gastric 300 does not have any impact on current avelumab approvals.

JAVELIN Gastric 300 is a Phase III, multicenter, international, randomized, open-label clinical trial investigating avelumab plus best supportive care versus physician’s choice of protocol-specified chemotherapy (paclitaxel or irinotecan monotherapy) plus best supportive care in patients with unresectable, recurrent or metastatic gastric or GEJ adenocarcinoma whose disease has progressed following two prior therapeutic regimens. The trial enrolled 371 patients from 147 sites in Asia, Australia, Europe, North America and South America. The primary endpoint was OS.

The avelumab gastric clinical development program also includes JAVELIN Gastric 100, a multicenter, randomized, open-label Phase III study evaluating avelumab as first-line maintenance therapy following induction chemotherapy in unresectable, locally advanced or metastatic gastric or GEJ cancer. The trial will continue as planned.

*Avelumab is under clinical investigation for treatment of gastric/GEJ cancer and has not been demonstrated to be safe and effective for this indication. There is no guarantee that avelumab will be approved for gastric/GEJ cancer by any health authority worldwide.

About Gastric/Gastroesophageal Junction Cancer
Globally, gastric cancer is the fifth most common cancer but the third most common cause of cancer death.[1],[2] In 2012, there were approximately 950,000 new cases and 723,000 deaths worldwide.[3] Of these cancers, 90 to 95 percent were adenocarcinomas.[4] Incidence varies by country, with higher rates seen in Central/Eastern Europe, Eastern Asia and South America.[5] Survival in advanced disease is poor and generally less than one year.[6] Globally, there is no recommended therapeutic approach for patients who progress after two lines of therapy for recurrent or metastatic gastric cancer.

About Avelumab
Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody. Avelumab has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, avelumab has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.[7]-[9] Avelumab has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.[9]-[11] In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.

Approved Indications in the US
The FDA granted accelerated approval for avelumab (BAVENCIO) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Important Safety Information from the US FDA Approved Label
BAVENCIO can cause immune-mediated pneumonitis, including fatal cases. Monitor patients for signs and symptoms of pneumonitis, and evaluate suspected cases with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold BAVENCIO for moderate (Grade 2) and permanently discontinue for severe (Grade 3), life-threatening (Grade 4), or recurrent moderate (Grade 2) pneumonitis. Pneumonitis occurred in 1.2% (21/1738) of patients, including one (0.1%) patient with Grade 5, one (0.1%) with Grade 4, and five (0.3%) with Grade 3.

BAVENCIO can cause immune-mediated hepatitis, including fatal cases. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater hepatitis. Withhold BAVENCIO for moderate (Grade 2) immune-mediated hepatitis until resolution and permanently discontinue for severe (Grade 3) or life-threatening (Grade 4) immune-mediated hepatitis. Immune-mediated hepatitis was reported in 0.9% (16/1738) of patients, including two (0.1%) patients with Grade 5, and 11 (0.6%) with Grade 3.

BAVENCIO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold BAVENCIO until resolution for moderate or severe (Grade 2 or 3) colitis, and permanently discontinue for life-threatening (Grade 4) or recurrent (Grade 3) colitis upon reinitiation of BAVENCIO. Immune-mediated colitis occurred in 1.5% (26/1738) of patients, including seven (0.4%) with Grade 3.

BAVENCIO can cause immune-mediated endocrinopathies, including adrenal insufficiency, thyroid disorders, and type 1 diabetes mellitus.

Monitor patients for signs and symptoms of adrenal insufficiency during and after treatment, and administer corticosteroids as appropriate. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiency. Adrenal insufficiency was reported in 0.5% (8/1738) of patients, including one (0.1%) with Grade 3.

Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation. Manage hypothyroidism with hormone replacement therapy and hyperthyroidism with medical management. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) thyroid disorders. Thyroid disorders, including hypothyroidism, hyperthyroidism, and thyroiditis, were reported in 6% (98/1738) of patients, including three (0.2%) with Grade 3.

Type 1 diabetes mellitus including diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Withhold BAVENCIO and administer antihyperglycemics or insulin in patients with severe or life-threatening (Grade ≥ 3) hyperglycemia, and resume treatment when metabolic control is achieved. Type 1 diabetes mellitus without an alternative etiology occurred in 0.1% (2/1738) of patients, including two cases of Grade 3 hyperglycemia.

BAVENCIO can cause immune-mediated nephritis and renal dysfunction. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater nephritis. Withhold BAVENCIO for moderate (Grade 2) or severe (Grade 3) nephritis until resolution to Grade 1 or lower. Permanently discontinue BAVENCIO for life-threatening (Grade 4) nephritis. Immune-mediated nephritis occurred in 0.1% (1/1738) of patients.

BAVENCIO can result in other severe and fatal immune-mediated adverse reactions involving any organ system during treatment or after treatment discontinuation. For suspected immune-mediated adverse reactions, evaluate to confirm or rule out an immune-mediated adverse reaction and to exclude other causes. Depending on the severity of the adverse reaction, withhold or permanently discontinue BAVENCIO, administer high-dose corticosteroids, and initiate hormone replacement therapy, if appropriate. Resume BAVENCIO when the immune-mediated adverse reaction remains at Grade 1 or lower following a corticosteroid taper. Permanently discontinue BAVENCIO for any severe (Grade 3) immune-mediated adverse reaction that recurs and for any life-threatening (Grade 4) immune-mediated adverse reaction. The following clinically significant immune-mediated adverse reactions occurred in less than 1% of 1738 patients treated with BAVENCIO: myocarditis with fatal cases, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barré syndrome, and systemic inflammatory response.

BAVENCIO can cause severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Patients should be premedicated with an antihistamine and acetaminophen prior to the first 4 infusions and for subsequent doses based upon clinical judgment and presence/severity of prior infusion reactions. Monitor patients for signs and symptoms of infusion-related reactions, including pyrexia, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. Interrupt or slow the rate of infusion for mild (Grade 1) or moderate (Grade 2) infusion-related reactions. Permanently discontinue BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Infusion-related reactions occurred in 25% (439/1738) of patients, including three (0.2%) patients with Grade 4 and nine (0.5%) with Grade 3.

BAVENCIO can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus including the risk of fetal death. Advise females of childbearing potential to use effective contraception during treatment with BAVENCIO and for at least 1 month after the last dose of BAVENCIO. It is not known whether BAVENCIO is excreted in human milk. Advise a lactating woman not to breastfeed during treatment and for at least 1 month after the last dose of BAVENCIO due to the potential for serious adverse reactions in breastfed infants.

The most common adverse reactions (all grades, ≥ 20%) in patients with metastatic Merkel cell carcinoma (MCC) were fatigue (50%), musculoskeletal pain (32%), diarrhea (23%), nausea (22%), infusion-related reaction (22%), rash (22%), decreased appetite (20%), and peripheral edema (20%).

Selected treatment-emergent laboratory abnormalities (all grades, ≥ 20%) in patients with metastatic MCC were lymphopenia (49%), anemia (35%), increased aspartate aminotransferase (34%), thrombocytopenia (27%), and increased alanine aminotransferase (20%).

The most common adverse reactions (all grades, ≥ 20%) in patients with locally advanced or metastatic urothelial carcinoma (UC) were fatigue (41%), infusion-related reaction (30%), musculoskeletal pain (25%), nausea (24%), decreased appetite/hypophagia (21%), and urinary tract infection (21%).

Selected laboratory abnormalities (Grades 3-4, ≥ 3%) in patients with locally advanced or metastatic UC were hyponatremia (16%), increased gamma-glutamyltransferase (12%), lymphopenia (11%), hyperglycemia (9%), increased alkaline phosphatase (7%), anemia (6%), increased lipase (6%), hyperkalemia (3%), and increased aspartate aminotransferase (3%).

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Alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc., New York, US
Immuno-oncology is a top priority for Merck KGaA, Darmstadt, Germany, and Pfizer. The global strategic alliance between Merck KGaA, Darmstadt, Germany, and Pfizer enables the companies to benefit from each other’s strengths and capabilities and further explore the therapeutic potential of avelumab, an anti-PD-L1 antibody initially discovered and developed by Merck KGaA, Darmstadt, Germany. The immuno-oncology alliance is jointly developing and commercializing avelumab and advancing Pfizer’s PD-1 antibody. The alliance is focused on developing high-priority international clinical programs to investigate avelumab, as a monotherapy, as well as combination regimens, and is striving to find new ways to treat cancer.

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