On October 7, 2019 Verastem, Inc. (Nasdaq: VSTM), (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, reported that its partner Yakult Honsha Co., Ltd. (Yakult) has dosed the first patient in a Phase 1b Japanese bridging study evaluating COPIKTRA (duvelisib) in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) following at least one prior therapy (Press release, Verastem, OCT 7, 2019, View Source [SID1234540089]). COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma in the United States.

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"The start of patient dosing in Yakult’s first clinical study of COPIKTRA in Japan is another important step forward in Verastem Oncology’s strategy to expand the global potential of COPIKTRA for hematological malignancies across the globe," said Brian Stuglik, Chief Executive Officer of Verastem Oncology. "The results of this study are expected to form the basis of a regulatory submission for COPIKTRA for the treatment of relapsed or refractory CLL/SLL in Japan, where therapies are extremely limited. We look forward to supporting Yakult through the clinical development of COPIKTRA in Japan to help rapidly advance this oral, novel therapy for patients living with CLL/SLL."

Verastem and Yakult entered into an exclusive licensing agreement in June 2018 for Yakult to develop and commercialize COPIKTRA for the treatment, prevention or diagnosis of all oncology indications in Japan. Yakult’s Phase 1b, multicenter, open-label study is expected to enroll approximately 10 patients with relapsed or refractory CLL/SLL after at least one prior therapy. The primary endpoint of the study is objective response rate. Secondary endpoints of the study include overall survival, progression free survival and safety. This Phase 1b study is expected to serve as a bridging study based on the efficacy and safety observed in Verastem Oncology’s Phase 3 DUO study. The results of the Phase 1b bridging study are expected to form the basis of a regulatory submission for COPIKTRA for the treatment of relapsed or refractory CLL/SLL in Japan.

COPIKTRA was approved in September 2018 by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory CLL/SLL after at least two prior therapies. In addition, COPIKTRA has been granted accelerated approval by the FDA for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Accelerated approval in FL was based on overall response rate and continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

About COPIKTRA (duvelisib)

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. COPIKTRA is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status, and is being investigated in combination with other agents through investigator-sponsored studies.4 For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

SELECT IMPORTANT SAFETY INFORMATION

This does not include all information needed to use COPIKTRA (duvelisib) safety and effectively. See full Prescribing Information.

WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS

See full Prescribing Information for complete boxed warning

Fatal and/or serious infections occurred in 31% of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected.

Fatal and/or serious diarrhea or colitis occurred in 18% of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA.

Fatal and/or serious cutaneous reactions occurred in 5% of COPIKTRA-treated patients. Withhold COPIKTRA.

Fatal and/or serious pneumonitis occurred in 5% of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA.

INDICATIONS AND USAGE

COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with:

Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.

Relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Accelerated approval based on overall response rate and continued approval may be contingent upon confirmatory trials

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Monitor hepatic function.

Neutropenia: Monitor blood counts.

Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS

The most common adverse reactions (≥20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.

To report Adverse Reactions, contact FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch and Verastem Oncology at 1-877-7RXVSTM (1-877-779-8786).

DRUG INTERACTIONS

CYP3A inducers: Avoid co-administration with strong CYP3A inducers.

CYP3A inhibitors: Monitor for COPIKTRA toxicities when co-administered with strong or moderate CYP3A inhibitors. Reduce COPIKTRA dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors.

CYP3A substrates: Monitor for signs of toxicities when co-administering COPIKTRA with sensitive CYP3A substrates.

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed.

On October 7, 2019 Vaccibody AS reported that preliminary safety, efficacy and immunogenicity data will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2019 which will be held from November 6-10, 2019 in National Harbor, Maryland (Press release, Vaccibody, OCT 7, 2019, View Source [SID1234540088]).

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"We are excited that our abstract presenting Vaccibody’s preliminary VB10.NEO clinical read-outs has been accepted for poster presentation at this year’s SITC (Free SITC Whitepaper) Meeting," said Michael Engsig, CEO of Vaccibody. The poster will be the first presentation to report clinical data from our VB10.NEO cancer neoantigen study and is an important milestone for the company.

Details of the poster presentation:

Title: Preliminary safety, efficacy and immunogenicity results from a phase 1/2a study (DIRECT-01) of cancer neoantigen DNA vaccine VB10.NEO in patients with locally advanced or metastatic solid tumors

Abstract ID: P424

Session Date and Time: Saturday, November 9 th 2019, 7:00 am-8:30 pm local time

About VB10.NEO
VB10.NEO, is a proprietary therapeutic DNA vaccine which uses the patient’s own neoantigens for the personalized treatment of cancer patients. A phase I/IIa neoantigen clinical trial is currently enrolling patients with locally advanced or metastatic melanoma, non-small cell lung carcinoma, clear renal cell carcinoma as well as urothelial cancer or squamous cell carcinoma of the head and neck.

On October 7, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported that preliminary clinical data for the company’s noninvasive nasal swab test – the first of its kind – for early detection of lung cancer will be presented at the annual meeting of the American College of Chest Physicians (CHEST), being held October 18-23 in New Orleans (Press release, Veracyte, OCT 7, 2019, View Source [SID1234540087]). The presentation will highlight the early performance characteristics and intended use of the novel genomic test.

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Additionally, data from five studies demonstrating the clinical performance and utility of Veracyte’s Percepta Genomic Sequencing Classifier (GSC) and Envisia Genomic Classifier – which are used to improve the diagnosis of lung cancer and idiopathic pulmonary fibrosis (IPF), respectively – will be presented during the CHEST meeting.

"We look forward to the CHEST meeting, where data from multiple studies will demonstrate our genomic tests’ ability to answer important clinical questions that inform diagnosis and treatment decisions for patients with suspected cancer or other diseases," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "This includes five studies reinforcing the value that our Percepta and Envisia genomic classifiers provide to patients with potential lung cancer and interstitial lung diseases, including IPF. We are particularly excited to share new data that demonstrate significant progress in our development of the first noninvasive nasal swab test for early lung cancer detection."

Following are details regarding the nasal swab test data presentation at CHEST:

Title:

Lung Cancer Detection via Whole-Transcriptome RNA Sequencing of Nasal Epithelium

Presenter:

Carla R. Lamb, M.D., Lahey Hospital & Medical Center

Date/Time:

Tuesday, October 22, 1:00-2:00 p.m. CT

Location:

Ernest N. Morial Convention Center, Exhibit Hall – Poster Area 1

Abstract #:

4224

Following are details regarding the clinical utility data presentations for the Envisia Genomic Classifier:

Title:

Evaluating Clinical Utility of a UIP Genomic Classifier in Subjects With and Without a HRCT Pattern of UIP

Presenter:

Jonathan H. Chung, M.D., The University of Chicago Medicine

Date/Time:

Sunday, October 20, 2:30-2:45 p.m. CT

Location:

Ernest N. Morial Convention Center, Room 291

Abstract #:

4010 (oral presentation)

Title:

Combining Radiology and Envisia, a Molecular Classifier, to Improve Usual Interstitial Pneumonia (UIP) Diagnosis

Presenter:

Sadia Benzaquen, M.D., University of Cincinnati College of Medicine

Date/Time:

Monday, October 21, 1:45-2:00 p.m. CT

Location:

Ernest N. Morial Convention Center, Room 281

Abstract #:

4060 (oral presentation)

Title:

Employing Bronchoscopic Lung Cryobiopsy and a Genomic Classifier in the Multidisciplinary Diagnosis of Diffuse Interstitial Lung Diseases

Presenter:

Fayez Kheir, M.D., Tulane University School of Medicine

Date/Time:

Tuesday, October 22, 8:45-9:45 a.m. CT

Location:

Ernest N. Morial Convention Center, Room 288

Abstract #:

4805 (oral presentation)

Following are details for the clinical performance and utility data presentations for the Percepta classifier:

Title:

Improving Indeterminate Pulmonary Nodule Management with the Percepta Genomic Sequencing Classifier

Presenter:

Peter Mazzone, M.D., M.P.H., Cleveland Clinic

Date/Time:

Wednesday, October 23, 10:45-11:45 a.m. CT

Location:

Ernest N. Morial Convention Center, Room 298

Abstract #:

4815 (oral presentation)

Title:

Use of Percepta Genomic Classifier in Lung Nodule Management: A County Hospital Experience

Presenter:

Waasil Kareem, M.D., Keck School of Medicine of the University of Southern California

Date/Time:

Wednesday, October 23, 9:45-10:45 a.m. CT

Location:

Ernest N. Morial Convention Center, Exhibit Hall – Poster Area 4

Abstract #:

4232 (poster presentation)

On October 7, 2019 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported updated median overall survival data from its Phase 1/2 KEYNOTE-046 study in metastatic, castration-resistant prostate cancer (mCRPC) (Press release, Advaxis, OCT 7, 2019, View Source [SID1234540086]). This trial is being conducted in conjunction with Merck (known as MSD outside the U.S. and Canada) and is evaluating ADXS-PSA, one of Advaxis’ Listeria monocytogenes (Lm)-based immunotherapies, alone and in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy.

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At the final data cutoff of September 16, 2019, median overall survival for 37 patients in the combination arm was 33.6 months (95% CI, range 15.4-33.6 months). This updated median overall survival is an increase from the previous data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April, where median overall survival was 21.1 months in the combination arm. These new data, along with additional details from this final predetermined look at the trial results, will be presented at an upcoming medical conference.

"We are excited to report these updated data which show a meaningful increase in median overall survival for patients in the combination arm of the KEYNOTE-046 study," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "We believe that ADXS-PSA in combination with KEYTRUDA has the potential to be an important new treatment option for patients with advanced metastatic, castration-resistant prostate cancer, which based on these data, warrants further evaluation. We are currently assessing next steps for a potential new study for ADXS-PSA in combination with KEYTRUDA in mCRPC and we look forward to providing additional details about the program’s path forward."

Mark N. Stein M.D., FACS, Associate Professor of Medical Oncology at Columbia University Medical Center and lead investigator of the study, said, "Patients with metastatic castration-resistant prostate cancer who have failed next generation hormonal agents and/or docetaxel have limited treatment options. The updated survival data in a patient population with advanced prostate cancer suggests this generally well tolerated vaccine should be evaluated in larger studies. I look forward to the continued evaluation of ADXS-PSA in combination with KEYTRUDA as a potential new treatment regimen that can improve patient outcomes while preserving quality of life."

KEYNOTE-046 is an open-label, multicenter, dose-determining safety and tolerability Phase 1/2 trial of 50 heavily pretreated patients conducted in two parts (Part A and Part B), with a Phase 2 expansion cohort. The objective of the study is to evaluate ADXS-PSA alone (Part A) and in combination with KEYTRUDA (Part B) for primary endpoints that include safety, tolerability and dosing. Secondary endpoints include anti-tumor activity, progression-free survival and overall survival, and exploratory endpoints that include associations between biomarkers of immunologic response (serum PSA) with clinical outcomes. Enrollment in the study has been completed. The majority of treatment-related adverse events consisted of transient and reversible Grade 1-2 chills/rigors, fever, hypotension, nausea and fatigue. The combination of ADXS-PSA and KEYTRUDA has appeared to be well-tolerated, to date, with no additive toxicity observed.

About KEYNOTE-046

KEYNOTE-046 (NCT02325557) is a Phase 1/2 open-label, multicenter, dose-determination and expansion trial that evaluates the safety, tolerability and preliminary clinical activity of ADXS-PSA as monotherapy (Part A; n=14 [13 treated]), and in combination with KEYTRUDA (Part B; n= 37) in heavily pretreated patients with progressive and refractory mCRPC.

On October 7, 2019 Syndax Pharmaceuticals presented the corporate presentation (Presentation, Syndax, OCT 7, 2019, View Source [SID1234540085]).

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