On April 11, 2016 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported that the abstract titled "Clinical safety and activity from a phase 1 study of LOXO-101, a selective TRKA/B/C inhibitor, in solid-tumor patients with NTRK gene fusions" has been accepted for oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 16 – 20, 2016 in New Orleans (Press release, Loxo Oncology, APR 11, 2016, View Source [SID:1234510662]). Data from this trial were most recently presented at the AACR (Free AACR Whitepaper)-NCI-EORTC meeting in November 2015. The presentation will include an efficacy and durability update for enrolled patients with TRK fusions. The presentation was selected for inclusion in AACR (Free AACR Whitepaper)’s official press program, and study data will therefore remain embargoed until April 17, 2016 at 4:15 p.m. CT.

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The schedule for the oral presentation is as follows:

Oral Presentation Date & Time: April 17, 2016, 4:15 p.m. to 6:00 p.m. CT
Title: Clinical Safety and Activity from a Phase 1 Study of LOXO-101, a Selective TRKA/B/C Inhibitor, in Solid Tumor Patients with NTRK Gene Fusions
Abstract Number: CT008
Session Title: Precision Medicine Early Clinical Trials
Presenter: David Hong, M.D., deputy chair, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center
Location: La Nouvelle Orleans Ballroom, Morial Convention Center

Conference Call and Webcast Information

Loxo Oncology will host a conference call and live webcast on Monday, April 18, 2016 at 8:00 a.m. Eastern Time to discuss the LOXO-101 data. To participate in the conference call, please dial (877) 930-8065 (domestic) or (253) 336-8041 (international) and refer to conference ID 77038770. A live webcast of the presentation will be available at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the company’s website for 30 days following the call.

About LOXO-101

LOXO-101 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In an ongoing Phase 1 clinical trial, LOXO-101 has demonstrated encouraging preliminary efficacy. LOXO-101 is also being evaluated in a global Phase 2 multi-center basket trial in patients with solid tumors that harbor TRK gene fusions. For additional information about both the LOXO-101 clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123.

On April 11, 2016 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for atezolizumab (anti-PDL1; MPDL3280A) for the treatment of people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease expresses the protein PD-L1 (programmed death ligand-1), as determined by an FDA-approved test, and who have progressed on or after platinum-containing chemotherapy (Press release, Roche Molecular Diagnostics, APR 11, 2016, View Source [SID:1234510663]).

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"In a study of atezolizumab in people with previously treated advanced lung cancer, PD-L1 expression correlated with how well they responded to the medicine," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "The goal of PD-L1 as a biomarker is to identify people most likely to benefit from atezolizumab alone."

Atezolizumab was granted Breakthrough Therapy Designation by the FDA in February 2015 for the treatment of people whose NSCLC expresses PD-L1 and whose disease progressed during or after standard treatments (e.g., platinum-based chemotherapy and appropriate targeted therapy for EGFR mutation-positive or ALK-positive disease). Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure that people have access to them through FDA approval as soon as possible. The BLA submission for atezolizumab is based on results from clinical trials including the Phase II BIRCH study, and the FDA will make a decision on approval by Oct. 19, 2016. A Premarket Application (PMA) is also under review by the FDA for a companion immunohistochemistry (IHC) test developed by Roche Tissue Diagnostics.
This is the second BLA acceptance and priority review for atezolizumab. On 15th March, Roche announced that the FDA had accepted the company’s BLA and granted Priority Review for atezolizumab for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who had disease progression during or following platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). Atezolizumab is also being studied in a number of other cancers.

About the BIRCH study
BIRCH is an open-label, multicenter, single-arm Phase II study that evaluated the safety and efficacy of atezolizumab in 667 people with locally advanced or metastatic NSCLC whose disease expressed PD-L1. PD-L1 expression was assessed for both tumor cells and tumor-infiltrating immune cells with an investigational IHC test based on the SP142 antibody. People in the study received a 1200-mg intravenous dose of atezolizumab every three weeks. The primary endpoint of the study was objective response rate (ORR) as assessed by an independent review facility (IRF) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary endpoints included duration of response (DOR), overall survival, progression-free survival and safety.

About non-small cell lung cancer
Lung cancer is the leading cause of cancer death globally. Each year 1.59 million people die as a result of the disease; this translates into more than 4,350 deaths worldwide every day. Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.

About atezolizumab
Atezolizumab (also known as MPDL3280A; anti-PDL1) is an investigational monoclonal antibody designed to bind with a protein called programmed death ligand-1 (PD-L1). Atezolizumab is designed to directly bind to PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with PD-1 and B7.1 receptors. By inhibiting PD-L1, atezolizumab may enable the activation of T cells. Atezolizumab may also affect normal cells.

About personalised cancer immunotherapy
The aim of personalised cancer immunotherapy (PCI) is to provide individual patients with treatment options that are tailored to their specific needs. Our PCI research and development programme comprises more than 20 investigational candidates, eight of which are in clinical trials. All studies include the prospective evaluation of biomarkers to determine which people may be appropriate candidates for our medicines. In the case of atezolizumab, PCI begins with the PD-L1 (programmed death ligand-1) IHC assay based on the SP142 antibody developed by Roche Tissue Diagnostics. The goal of PD-L1 as a biomarker is to identify those people most likely to experience clinical benefit with atezolizumab as a single agent versus those who may benefit more from combination approaches; the purpose is to inform treatment strategies which will give the greatest number of patients a chance for transformative benefit.The ability to combine atezolizumab with multiple chemotherapies may provide new treatment options to people across a broad range of tumours regardless of their level of PD-L1 expression.

Personalised Cancer Immunotherapy is an essential component of how Roche deliver on the broader commitment to personalised healthcare. For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

On April 11, 2016 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for atezolizumab (anti-PDL1; MPDL3280A) for the treatment of people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease expresses the protein PD-L1 (programmed death ligand-1), as determined by an FDA-approved test, and who have progressed on or after platinum-containing chemotherapy (Press release, Hoffmann-La Roche , APR 11, 2016, View Source [SID:1234510637]).

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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

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"In a study of atezolizumab in people with previously treated advanced lung cancer, PD-L1 expression correlated with how well they responded to the medicine," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "The goal of PD-L1 as a biomarker is to identify people most likely to benefit from atezolizumab alone."

Atezolizumab was granted Breakthrough Therapy Designation by the FDA in February 2015 for the treatment of people whose NSCLC expresses PD-L1 and whose disease progressed during or after standard treatments (e.g., platinum-based chemotherapy and appropriate targeted therapy for EGFR mutation-positive or ALK-positive disease). Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure that people have access to them through FDA approval as soon as possible. The BLA submission for atezolizumab is based on results from clinical trials including the Phase II BIRCH study, and the FDA will make a decision on approval by Oct. 19, 2016. A Premarket Application (PMA) is also under review by the FDA for a companion immunohistochemistry (IHC) test developed by Roche Tissue Diagnostics.

This is the second BLA acceptance and priority review for atezolizumab. On 15th March, Roche announced that the FDA had accepted the company’s BLA and granted Priority Review for atezolizumab for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who had disease progression during or following platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). Atezolizumab is also being studied in a number of other cancers.

About the BIRCH study

BIRCH is an open-label, multicenter, single-arm Phase II study that evaluated the safety and efficacy of atezolizumab in 667 people with locally advanced or metastatic NSCLC whose disease expressed PD-L1. PD-L1 expression was assessed for both tumor cells and tumor-infiltrating immune cells with an investigational IHC test based on the SP142 antibody. People in the study received a 1200-mg intravenous dose of atezolizumab every three weeks. The primary endpoint of the study was objective response rate (ORR) as assessed by an independent review facility (IRF) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary endpoints included duration of response (DOR), overall survival, progression-free survival and safety.

About non-small cell lung cancer

Lung cancer is the leading cause of cancer death globally. Each year 1.59 million people die as a result of the disease; this translates into more than 4,350 deaths worldwide every day. Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.

About atezolizumab

Atezolizumab (also known as MPDL3280A; anti-PDL1) is an investigational monoclonal antibody designed to bind with a protein called programmed death ligand-1 (PD-L1). Atezolizumab is designed to directly bind to PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with PD-1 and B7.1 receptors. By inhibiting PD-L1, atezolizumab may enable the activation of T cells. Atezolizumab may also affect normal cells.

About personalised cancer immunotherapy

The aim of personalised cancer immunotherapy (PCI) is to provide individual patients with treatment options that are tailored to their specific needs. Our PCI research and development programme comprises more than 20 investigational candidates, eight of which are in clinical trials. All studies include the prospective evaluation of biomarkers to determine which people may be appropriate candidates for our medicines. In the case of atezolizumab, PCI begins with the PD-L1 (programmed death ligand-1) IHC assay based on the SP142 antibody developed by Roche Tissue Diagnostics. The goal of PD-L1 as a biomarker is to identify those people most likely to experience clinical benefit with atezolizumab as a single agent versus those who may benefit more from combination approaches; the purpose is to inform treatment strategies which will give the greatest number of patients a chance for transformative benefit.The ability to combine atezolizumab with multiple chemotherapies may provide new treatment options to people across a broad range of tumours regardless of their level of PD-L1 expression.

Personalised Cancer Immunotherapy is an essential component of how Roche deliver on the broader commitment to personalised healthcare. For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

On April 11 , 2016 – MSD K.K. also known as Merck in the US and Canada (MSD; President and Representative Director : Tony Alvarez) and Taiho Pharmaceutical C o ., L td . ( Taiho ; President and Representative Director : Masayuki Kobayashi) reported that they have entered into a co – promotion agreement in Japan for pembrolizumab (generic name; development code: MK – 3475) , an immune checkpoint inhibitor (anti – PD – 1 therapy) of which MSD has filed an application for approval in Japan (Press release, Taiho, APR 11, 2016, View Source [SID:1234512291]).

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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

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Under the agreement, T aiho will co-promote pembrolizumab with MSD while MSD will manufacture and distribute it.

Pembrolizumab , an immune checkpoint inhibitor (anti – PD – 1 therapy), is a humanized monoclonal antibody that blocks the interaction between PD – 1 mainly expressed on activated lymphocytes with anti – tumor activity, and its ligands, PD – L1 and PD – L2 expressed mainly on tumor cells. By binding to the PD – 1 receptor and blocking the interaction with the receptor ligands, pembrolizumab releases the PD – 1 pathway – mediated inhibition of the immune response, including the anti – tumor immune response.

In Japan, an application for marketing approval was submitted for the anti – PD – 1 antibody pembrolizumab (genetic recombination), for the treatment of patients with unresectable or metastatic melanoma on December 22, 2015, and for the treatment of patients with unresectable advanced or recurrent non – small cell lung cancer on February 29, 2016.

The ongoing clinical program s are for bladder cancer, lung cancer, breast cancer, gastric cancer, head and neck cancer, multiple myeloma, esophageal cancer, colorectal cancer, Hodgkin’s lymphoma, and a dvanced solid tumor. Pembrolizumab is one of the first medicines included in the Ministry of Health, Labor and Welfare’s Sakigake Fast – Track Review, for the treatment of unresectable advanced or recurrent gastric cancer on October 27, 2015. MSD and Taiho will further contribute to patients and healthcare providers in the oncology area by establishing a close partnership with co-promotion of pembrolizumab, a promising new option for cancer treatment

On April 11, 2016 Aduro Biotech, Inc. (Nasdaq:ADRO), reported that the company’s chief scientific officer, Thomas W. Dubensky, Jr., Ph.D., will be a featured speaker at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2016 Annual Meeting being held April 16-20 in New Orleans, Louisiana (Press release, Aduro BioTech, APR 11, 2016, View Source;p=RssLanding&cat=news&id=2155861 [SID:1234510645]). Dr. Dubensky’s presentation is part of a Major Symposium, "Cancer Immunotherapy: Small Molecule Approaches," taking place on April 20, 2016, during which he will highlight Aduro’s landmark first-in-human immunotherapeutic approach in cancer to target the Stimulator of Interferon Genes (STING) pathway.

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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

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The presentation will focus on ADU-S100, a novel synthetic cyclic dinucleotide (CDN) that is one of a family of proprietary small molecules being developed by Aduro that broadly activates the human STING receptor. STING is expressed in immune cells that are present in the tumor microenvironment (TME) and is a central and potent mediator of the innate immune response, a necessary step in the development of effective tumor-specific immunity. Activation of the STING pathway has been shown to correlate with infiltration of lymphocytes and a "T-cell inflamed TME" in patients with melanoma. Stimulation of STING induces signaling through several innate immune response pathways, resulting in the expression of various interferons, cytokines and T cell recruitment factors that amplify and strengthen immune activity. Dr. Dubensky will discuss preclinical data demonstrating that the direct engagement of STING through the intratumoral injection of ADU-S100 resulted in effective, durable and systemic anti-tumor activity. The data suggest that the resulting tumor regression is due to an acute pro-inflammatory cytokine response and induction of tumor-specific CD8+ T cell immunity. Preclinical data will be presented which also demonstrate the potential synergistic effects of combining ADU-S100 and immune checkpoint inhibitors, including anti-PD1. In addition, Dr. Dubensky will present an overview of the Phase 1 clinical trial to evaluate the safety, tolerability and possible anti-tumor activity of ADU-S100 given by intratumoral injection to patients with advanced cutaneously accessible solid tumors or lymphomas.

"We are excited to share this new research and planned Phase 1 clinical trial, which highlights ADU-S100, Aduro’s lead STING activator candidate, and its translational potential for treating patients with metastatic solid tumors and lymphomas," said Dr. Dubensky. "Our data suggest that the stimulation of a local immune response in the TME can result in a sustained and effective tumor-specific immune response against metastases throughout the body. This observation reinforces the importance of the STING signaling pathway in cancer immunotherapy and the potential of ADU-S100 to be used alone or in combination treatment approaches for advanced cancer patients."

Based on these promising preclinical results, Aduro and Novartis, as part of a collaboration focused on STING pathway activator compounds in the field of oncology, will initiate a Phase 1 dose escalation trial with ADU-S100 in patients with cutaneously accessible metastatic solid tumors or lymphomas who have no other treatment options.

Aduro will also be presenting a poster at AACR (Free AACR Whitepaper) on Monday, April 18, 2016 titled "STING Activation in the Tumor Microenvironment with a Synthetic Human Cyclic Dinucleotide Leads to Potent Anti-Tumor Immunity." This will provide additional details on preclinical research showing the effectiveness of ADU-S100 in activating the STING receptor and inducing an immune response across diverse tumor models.

Details of the presentations:

Oral Presentation "SY39-02: Direct activation of STING in the tumor microenvironment leads to potent and systemic tumor regression and immunity," Wednesday, April 20, 2016 10:55 AM – 11:20 AM, New Orleans Theater C. Morial Convention Center
Poster Presentation "STING Activation in the Tumor Microenvironment with a Synthetic Human Cyclic Dinucleotide Leads to Potent Anti-Tumor Immunity," Monday, April 18, 2016 8:00 AM – 12:00 PM, Section 24