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Varian Medical Systems Supports Trial on Lung Cancer Radiosurgery

On April 18, 2016 Varian Medical Systems (NYSE: VAR) reported it is supporting a phase III trial comparing outcomes of radiosurgery versus surgical resection for the treatment of early-stage, high-risk, operable non-small cell lung cancer (NSCLC) (Press release, InfiMed, APR 18, 2016, View Source [SID:1234510962]).

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Known as the "Stablemates Trial," the randomized study will test the hypothesis that the 3-year overall survival in high risk operable patients with stage I NSCLC is equivalent or greater in patients who undergo stereotactic ablative radiotherapy (SAbR) as compared with conventional sublobar resection (SR) surgery. Led by co-chairs Hiran Fernando, MD, Boston Medical Center, and Robert Timmerman, MD, University of Texas Southwestern Medical Center, the study currently involves 34 institutions and 258 patients.

"In addition to a potentially longer survival rate, SAbR may benefit some lung cancer patients by offering them a noninvasive, outpatient treatment option that is easier to tolerate and that doesn’t interfere greatly with their normal, everyday living activities," said Dr. Timmerman.

Sponsored by the Joint Lung Cancer Trialist’s Coalition, the study is being administered by the Department of Radiation Oncology at the University of Texas Southwestern Medical Center. Over the next five years, the study will examine patients’ overall, disease-free, and regional recurrence-free survival rates three years after treatment, as well as adverse events and post-treatment quality of life measures.

"Varian believes in supporting high quality clinical research," said Kolleen Kennedy, president of Varian’s Oncology Systems business. "This clinical trial presents the opportunity to advance radiation oncology and enhance the standard of patient care by giving clinicians a noninvasive treatment option in determining the appropriate therapy for patients."

Learn more about the Stablemates Trial at View Source

Bellicum Announces Late-Breaking Poster Presentation on TCR Product Candidate with Activation Switch at the American Association for Cancer Research (AACR) 2016 Annual Meeting

On April 18, 2016 Bellicum Pharmaceuticals, Inc. (Nasdaq:BLCM), a clinical stage biopharmaceutical company focused on discovering and developing novel cellular immunotherapies for cancers and orphan inherited blood disorders, reported that the Company, and its collaborating investigators at Leiden University Medical Center (LUMC), have been selected for a late-breaking poster presentation of a T cell receptor (TCR) product candidate containing the proprietary MyD88/CD40 activation switch (Go-TCR) at the AACR (Free AACR Whitepaper) 2016 Annual Meeting (Press release, Bellicum Pharmaceuticals, APR 18, 2016, View Source;p=RssLanding&cat=news&id=2157773 [SID:1234510961]). The conference will take place in New Orleans from April 16-20, 2016.

The presentation, titled "Go-TCR: Inducible MyD88/CD40 (iMC) Enhances Proliferation and Survival of Tumor-Specific TCR-Modified T Cells, Increasing Anti-Tumor Efficacy" will highlight preclinical data demonstrating that its novel "go" switch can augment activation and expansion of TCR-engineered T cells while sensitizing tumors to T cells via cytokine-induced MHC class I upregulation.

The poster will be available in the Events & Presentations section of the Bellicum website at the time of the presentation.

Presentation Details

Abstract Number: LB-084
Presentation Title: "Go-TCR: Inducible MyD88/CD40 (iMC) Enhances Proliferation and Survival of Tumor-Specific TCR-Modified T cells, Increasing Anti-Tumor Efficacy"
Presentation Date: Monday, April 18, 2016
Presentation Time: 8:00 a.m. -12:00 p.m. CDT

Heat Biologics and OncoSec Present Data at the American Conference for Cancer Research (AACR) Annual Meeting

On April 18, 2016 Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), an immuno-oncology company developing novel therapies that activate a patient’s immune system against cancer, reported that preclinical data from its collaboration with OncoSec Medical Incorporated ("OncoSec") focused on evaluating the combination of immunotherapy platforms were presented yesterday at the American Conference for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (www.aacr.org) (Press release, Heat Biologics, APR 18, 2016, View Source [SID:1234510953]).

In the poster entitled "In vivo intra-tumoral electroporation of gp96-Ig/Fc-OX40L stimulates CD8+ T cell cross-priming to tumor specific neoantigens" (Abstract #567), researchers concluded that combining Heat’s ComPACT vaccine with OncoSec’s intratumoral DNA electroporation delivery platform stimulated an expansion of neoantigen-specific CD8+ T cells, leading to a regression in both treated and untreated cancer lesions in two mouse studies (melanoma and colorectal cancer). Heat and OncoSec announced their collaboration last year to evaluate the preclinical efficacy of delivering Heat’s immunotherapy vaccines via OncoSec’s ImmunoPulse platform.

"In this first preclinical study demonstrating the feasibility of electroporating ComPACT DNA plasmids, we saw robust neoantigen T cell response and tumor regression in both treated and untreated tumors, indicating a systemic anti-tumor response that could be reflective of what we might see in metastatic lesions," said Taylor Schreiber, M.D., Ph.D., Heat’s Chief Scientific Officer. "We believe that this approach is promising and that further studies are merited, especially as this combination approach has the potential to stimulate shared and private tumor antigens without introducing the complexities associated with personalized therapies."

"We are excited by our collaboration with Heat and by these initial findings. The ability of the tumor’s microenvironment to evade immune recognition and remain non-immunogenic is a significant challenge, which we believe needs to be addressed when designing new immuno-therapies," added Robert H. Pierce, M.D., OncoSec’s Chief Scientific Officer. "The initial feasibility data between our two platforms are encouraging and we are currently exploring the potential synergy between our platforms with both ComPACT and interleukin-12 expressing plasmids."

Copies of the abstract are available and can be viewed online through the AACR (Free AACR Whitepaper) website at www.aacr.org. The poster is available in the Publications section of Heat’s corporate website.

Randomized Phase II placebo controlled study of codrituzumab in previously treated patients with advanced hepatocellular carcinoma.

Codrituzumab, a humanized monoclonal antibody against Glypican-3 (GPC3) that is expressed in HCC, interacts with CD16/ FcγRIIIa and triggers antibody-dependent cytotoxicity. Codrituzumab was studied versus placebo in a randomized phase II trial in advanced HCC patients who had failed prior systemic therapy.
Patients with advanced HCC who had failed prior systemic therapy, ⩾18 years, ECOG 0-1, Child-Pugh A were randomized 2:1 to biweekly codrituzumab 1600 mg versus placebo. Patients were stratified based on GPC3 immunohistochemical expression: 2+/3+, 1+, and 0. Primary endpoint was progression free survival (PFS). Secondary endpoints include overall survival (OS), tolerability, pharmacokinetics (PK), and an exploratory endpoint in biomarkers analysis.
185 patients were enrolled: 125 received codrituzumab and 60 placebo: Median age 64/63, 85/75% male, 46/42% Asian, ECOG 0 65/63%, 74/77% having vascular invasion and/or extra-hepatic metastasis. 84%/70% had prior sorafenib. Drug exposure was 98.4% of planned dose, with an identical adverse events profile between the 2 groups. The median PFS and OS in the codrituzumab versus placebo groups in months were: 2.6 versus 1.5 (HR 0.97, P=0.87), and 8.7 versus 10 (HR 0.96, P=0.82). Projected Ctrough at cycle 3 day 1 based exposure, high CD16/FcγRIIIa on peripheral immune cells, and GPC3 expression in the tumor, were all associated with prolonged PFS and OS.
Codrituzumab did not show clinical benefit in this previously treated HCC population. Whether higher codrituzumab drug exposure or the use of CD16 and GPC3 as potential biomarkers would improve outcome remain unanswered questions.
Codrituzumab is a manufactured antibody against a liver cancer protein called glypican-3. In this clinical trial, codrituzumab was not found be effective against liver cancer. It was suggested though that a higher dose of codrituzumab or selecting patients with high level of glypican-3 or its mediator CD16 might improve outcome.
Copyright © 2016. Published by Elsevier B.V.

nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine in Patients with Metastatic Pancreatic Adenocarcinoma: Canadian Subgroup Analysis of the Phase 3 MPACT Trial.

The phase III MPACT trial in patients with metastatic pancreatic cancer (MPC) demonstrated superior efficacy of nab-paclitaxel (nab-P) plus gemcitabine (Gem) compared with Gem monotherapy, including the primary endpoint of overall survival (OS; median 8.7 vs. 6.6 months; hazard ratio [HR] 0.72; P &lt; 0.001). A significant treatment difference favoring nab-P + Gem over Gem was observed for OS in patients treated in North America. The majority of patients were from the US (88%) with only 12% from Canada. Healthcare systems and treatment patterns are different between the 2 countries, and there is limited published information on outcomes of Canadian patients treated with first-line nab-P + Gem. This analysis evaluated efficacy and safety outcomes in Canadian patients in the MPACT trial.
Treatment-naive patients with MPC (N = 861) received either nab-P 125 mg/m(2) + Gem 1000 mg/m(2) on days 1, 8, and 15 every 4 weeks or Gem 1000 mg/m(2) weekly for the first 7 of 8 weeks (cycle 1) and then on days 1, 8, and 15 every 4 weeks (cycle ≥2).
The MPACT trial enrolled 63 patients in Canada. Baseline characteristics were well balanced and comparable with those of the intent-to-treat population. Both OS (median 11.9 vs. 7.1 months; HR 0.76; P = 0.373) and progression-free survival (median 7.2 vs. 5.2 months; HR 0.65; P = 0.224) were numerically longer and overall response rate (27% vs. 17%; P = 0.312) was numerically higher with nab-P + Gem vs. Gem. The most common grade ≥3 adverse events with nab-P + Gem vs. Gem were neutropenia (22% vs. 10%), fatigue (34% vs. 33%), and neuropathy (25% vs. 0%).
This subanalysis confirmed that nab-P + Gem is an efficacious treatment option and has a manageable safety profile in patients with MPC treated in Canada.
ClinicalTrials.gov identifier, NCT00844649.
Celgene Corporation, Summit, NJ, USA.