On May 16, 2018 Pfizer Inc. reported that new data from its diversified portfolio of marketed and investigational oncology medicines will be presented at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago from June 1-5, 2018 (Press release, Pfizer, MAY 16, 2018, View Source [SID1234526724]). Data from programs in small molecules, immunotherapies, biomarker-driven medicines, as well as biosimilars, will be featured in more than 40 abstracts, including company-sponsored and collaborative research studies.

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"The breadth and depth of our data at ASCO (Free ASCO Whitepaper) this year are indicative of our focus on understanding the full potential of our medicines, including IBRANCE and XTANDI, which are already making a difference in patient lives. We are also exploring new and exciting pathways designed to transform treatment outcomes"

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"The breadth and depth of our data at ASCO (Free ASCO Whitepaper) this year are indicative of our focus on understanding the full potential of our medicines, including IBRANCE and XTANDI, which are already making a difference in patient lives. We are also exploring new and exciting pathways designed to transform treatment outcomes," said Charles Hugh-Jones, MD, FRCP, chief medical officer, Pfizer Oncology. "Our comprehensive research is resulting in near-term potential benefits for patients, as well as multiple new therapies that we hope to introduce this year."

The research to be presented includes new insights on Pfizer’s late-phase investigational compounds dacomitinib, lorlatinib, talazoparib and glasdegib, as well as Pfizer’s marketed therapy XTANDI (enzalutamide). These compounds represent the next five potential Pfizer Oncology advancements in lung, breast, hematologic and prostate cancers.

"At this year’s ASCO (Free ASCO Whitepaper), we’re particularly excited to present overall survival data for dacomitinib that builds upon our precision medicine focus and legacy in lung cancer," said Mace Rothenberg, MD, chief development officer, Oncology, Pfizer Global Product Development. "Further, we’ll be sharing new insights on our medicines across 16 disease areas and 13 mechanisms of action, including early-phase through post-approval analyses. Our extensive presence reinforces our commitment to speeding accessible breakthrough medicines to patients."

Key Pfizer abstracts include:

The first presentation of final overall survival results from the pivotal ARCHER 1050 study of dacomitinib vs. gefitinib in locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutation
Phase 2 results from a clinical research collaboration evaluating IBRANCE (palbociclib) in combination with cetuximab in platinum-resistant HPV unrelated recurrent/metastatic head and neck squamous cell carcinoma
An analysis of resistance to therapy based on genetic mutations from the pivotal PALOMA-3 trial of CDK 4/6 inhibitor IBRANCE in combination with fulvestrant in ER+/HER2- metastatic breast cancer
Longer-term efficacy and safety results from two registrational trials: the JAVELIN Merkel 200 study of PD-L1 inhibitor BAVENCIO (avelumab) in a rare skin cancer, being developed in collaboration with Merck KGaA, Darmstadt, Germany and the BFORE trial of BOSULIF (bosutinib) vs. imatinib in patients with newly diagnosed chronic myeloid leukemia
A comparative clinical study of PF-06439535, a candidate bevacizumab biosimilar, and reference bevacizumab, in patients with advanced non-squamous non-small cell lung cancer
Details for the Pfizer-sponsored oral presentations are below:

Title/Abstract Number Date/Time (CDT) Location
(Abstract 9008) Friday, June 1 Hall D1
Avelumab (anti-PD-L1) in Combination with Crizotinib or Lorlatinib in Patients with Previously Treated Advanced NSCLC: Phase 1b Results from JAVELIN Lung 101 4:30 PM – 6:00 PM

Shaw A
(Abstract 7002) Saturday, June 2 E450
Bosutinib vs Imatinib for Newly Diagnosed Chronic Myeloid Leukemia in the BFORE Trial: 24-Month Follow-Up 3:00 PM – 6:00 PM

Cortes J
(Abstract 1001) Sunday, June 3 Hall D2
Genetic Landscape of Resistance to CDK4/6 Inhibition in Circulating Tumor DNA (ctDNA) Analysis of the PALOMA3 Trial of Palbociclib and Fulvestrant Versus Placebo and Fulvestrant 8:00 AM – 11:00 AM

Turner N
(Abstract 6008) Sunday, June 3 E451
Multicenter Phase 2 Trial of Palbociclib, a Selective Cyclin Dependent Kinase (CDK) 4/6 Inhibitor, and Cetuximab in Platinum-Resistant HPV Unrelated (-) Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (RM HNSCC)

8:00 AM – 11:00 AM

Adkins D
(Abstract 9507) Monday, June 4
Arie Crown Theater

Two-Year Efficacy and Safety Update from JAVELIN Merkel 200 Part A: A Registrational Study of Avelumab in Metastatic Merkel Cell Carcinoma Progressed on Chemotherapy 8:00 AM – 11:00 AM

Nghiem P
(Abstract 109) Monday, June 4 Hall D1
A Comparative Clinical Study of PF-06439535, a Candidate Bevacizumab Biosimilar, and Reference Bevacizumab, in Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer 9:45 AM – 11:15 AM

Socinski M
(Abstract 9004) Monday, June 4 Hall B1
Dacomitinib (daco) Versus Gefitinib (gef) for First-Line Treatment of Advanced NSCLC (ARCHER 1050): Final Overall Survival (OS) Analysis 3:00 PM – 6:00 PM

Mok T

Please see a complete list of Pfizer-sponsored abstracts featuring data on our broad pipeline of biologics and small molecules at View Source

Learn more about how developing new medicines and supporting people with cancer is personal for Pfizer Oncology at View Source

Dacomitinib, lorlatinib, talazoparib and glasdegib are investigational agents and have not been approved by any regulatory agencies.

On May 16, 2018 GRAIL, Inc., a healthcare company focused on the early detection of cancer, reported that new data from the Circulating Cell-free Genome Atlas (CCGA) Study will be presented during the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 1-5 in Chicago (Press release, Grail Bio, MAY 16, 2018, View Source [SID1234526723]). Data will be highlighted in four abstracts, including two oral presentations.

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Previously presented data from the first pre-planned sub-study of CCGA supported the possibility of developing a highly specific blood test for early detection of cancer with a very low rate of false positive results.1

New data from the same sub-study suggest a blood test can be developed to detect multiple types of cancer at early stages (Abstract 12021). Sensitivity analyses were conducted by sequencing blood samples from 878 participants with newly diagnosed cancer with three prototype genome sequencing assays. In general, results were comparable for the three prototype assays. Data for all three assays will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting. Results for the whole-genome bisulfite sequencing assay are reported in this press release. Detection rates (sensitivity at 98 percent specificity) ranged from 56 percent to 80 percent at early stages (stages I-III) in participants with cancer types that generally cause high mortality, including colorectal, esophageal, head and neck, liver, ovarian, pancreatic, and triple-negative breast cancers, as well as lymphoma and multiple myeloma.

Strong biological signal was also detected for lung cancer, the leading cause of cancer death globally, and these data will be highlighted in a late-breaking abstract that will be featured in ASCO (Free ASCO Whitepaper)’s press program on Saturday, June 2, 2018 (Abstract LBA8501).

Cancer types that exhibited low signal at early stages (less than 10 percent sensitivity), included prostate, thyroid, uterine, and renal cancers, and melanoma.

"Our initial CCGA results support the continued development of a highly specific blood test that can detect multiple cancer types early, when tumors can still be removed by surgery and treatment may be more successful," said Anne-Renee Hartman, MD, Vice President of Clinical Development. "These data are especially encouraging, as we were able to detect strong, blood-based biological signal at early stages for cancers that are responsible for the majority of cancer deaths globally, most of which are not typically screened for."

In this initial discovery phase of CCGA, three prototype genome sequencing assays were used to evaluate cancer-defining features in cell-free nucleic acids. The company is now verifying initial results from this CCGA sub-study in an independent data set from the same CCGA sub-study. The assays and GRAIL’s machine learning algorithms will then be optimized to determine the most informative genomic features for continued development and validation of a blood test for early detection of multiple cancer types in larger data sets in the CCGA and STRIVE studies.

Additional Results

Detection rates (sensitivity at 98 percent specificity) with the whole-genome bisulfite sequencing assay at stages I-III for cancer types with strong blood-based biological signal, are detailed in the table below. Detection rates for breast cancer subtypes at stages I-III are also detailed (Abstract 536).

The overall detection rate (sensitivity at 98 percent specificity) for breast cancer at stages I-III was 21 percent. Triple-negative breast cancer had strong biological signal at stages I-III (56 percent). Participants whose cancer was diagnosed through clinical presentation (diagnosis as a result of symptoms or through a different clinical setting than screening) had stronger signal than those diagnosed through screening mammography (sensitivity for stages I-IV breast cancer diagnosed through clinical presentation: 38 percent [95 percent confidence interval: 31 to 46 percent] vs. screen-detected breast cancer: 9 percent [95 percent confidence interval: 5 to 14 percent]).

Abstract LBA8501
Genome-wide sequencing for early stage lung cancer detection from plasma cell-free DNA (cfDNA): The Circulating Cell-free Genome Atlas (CCGA) study
ASCO Press Program: Saturday, June 2, 2018: 8:00-9:00am CDT
Oral Presentation: Monday, June 4, 2018: 8:12-8:24am CDT, Hall B1

Abstract 536
Breast cancer cell-free DNA (cfDNA) profiles reflect underlying tumor biology: The Circulating Cell-free Genome Atlas (CCGA) study
Poster Session: Saturday, June 2, 2018: 8:00-11:30am CDT, Hall A, Poster Board #28

Abstract 12021
Development of a comprehensive cell-free DNA (cfDNA) assay for early detection of multiple tumor types: The Circulating Cell-free Genome Atlas (CCGA) study
Poster Session: Monday, June 4, 2018: 1:15-4:45pm CDT, Hall A, Poster Board #134
Poster Discussion: Monday, June 4, 2018: 4:45-6:00pm CDT, Room S406

Abstract 12003
Prevalence of clonal hematopoiesis of indeterminate potential (CHIP) measured by an ultra-sensitive sequencing assay: Exploratory analysis of the Circulating Cell-free Genome Atlas (CCGA) study
Oral Presentation: Tuesday, June 5, 2018: 9:00-9:12am CDT, Room S406

About the First CCGA Sub-Study

In this pre-planned sub-study of CCGA, three prototype genome sequencing assays were evaluated as potential methods for a blood-based test for early cancer detection. In the first training phase of the sub-study, blood samples from 878 participants with newly diagnosed cancer who had not yet received treatment and 580 participants without diagnosed cancer were sequenced with all three prototype assays. Twenty different cancer types across all stages were included in the sub-study.

The prototype sequencing assays included:

Targeted sequencing of paired cell-free DNA (cfDNA) and white blood cells to detect somatic mutations such as single nucleotide variants and small insertions and/or deletions;
Whole-genome sequencing of paired cfDNA and white blood cells to detect somatic copy number changes; and
Whole-genome bisulfite sequencing of cfDNA to detect abnormal cfDNA methylation patterns.
About CCGA

CCGA is a prospective, observational, longitudinal study designed to characterize the landscape of cell-free nucleic acid (cfNA) profiles in people with and without cancer. The planned enrollment for the study is more than 15,000 participants across 141 sites in the United States and Canada. Approximately 70 percent of participants will have cancer at the time of enrollment (newly diagnosed, have not yet received treatment) and 30 percent will not have a known cancer diagnosis. The groups are demographically similar and representative of a real-world population. The group of participants without cancer includes individuals with conditions that are known to increase cfNA signal, such as inflammatory or autoimmune diseases. Planned follow-up for all participants is at least five years to collect clinical outcomes.

About STRIVE

STRIVE is a prospective, observational, longitudinal cohort study enrolling 120,000 women at the time of their screening mammogram. It is designed to evaluate blood tests for the early detection of multiple cancer types.

On May 16, 2018 MiNA Therapeutics, the pioneer in RNA activation therapeutics, reported that it will present preliminary results from its Phase I study of small activating RNA (saRNA) candidate MTL-CEBPA in liver cancer at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago from June 1 – 5 (Press release, MiNA Therapeutics, MAY 16, 2018, View Source [SID1234526722]). The data will be featured in a Poster Discussion Session in the Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics session. MiNA will announce the results through a press release following the presentation.

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Poster Discussion Session details:

Title: Preliminary results of a first-in-human, first-in-class phase I study of MTL-CEBPA, a small activating RNA (saRNA) targeting the transcription factor C/EBP-α in patients with advanced liver cancer
Abstract No: 2509
Session: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics
Date / Time: June 4, 2018 at 3:00pm – 4:15pmLocation: S406

About MTL-CEBPA
MTL-CEBPA consists of a double stranded RNA formulated into a SMARTICLES liposomal nanoparticle and is designed to activate the CEBPA gene. By restoring CEBPA expression to normal levels, MTL-CEBPA has been demonstrated to attenuate or reverse liver disease in a range of pre-clinical studies including models of liver cancer, liver cirrhosis, non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). MTL-CEBPA is currently under evaluation in OUTREACH, a first-in-human Phase I clinical study in patients with severe liver cancer. The multi-centre Phase I study is assessing the safety and tolerability of MTL-CEBPA in patients with advanced liver cancer who are ineligible or resistant to standard therapies. To learn more about the OUTREACH clinical study, please visit our listing at clinicaltrials.gov

On May 16, 2018 Turnstone Biologics reported it has received U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug Application (IND) for MG1-HPV for the treatment of patients with human papillomavirus (HPV) positive solid tumors (Press release, Turnstone Biologics, MAY 16, 2018, View Source [SID1234526721]). Additionally, Turnstone reported that it has entered into a clinical supply agreement with F. Hoffmann-La Roche Ltd ("Roche") under which Roche will provide atezolizumab (Tecentriq), its anti-PDL1 antibody, for use in combination with Turnstone’s Maraba virus immunotherapy platform, MG1.

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Turnstone will investigate the safety and efficacy of MG1-HPV therapy in combination with atezolizumab across a range of HPV positive tumors in a Phase I/II clinical study expected to commence in the second quarter of 2018.

"We are committed to helping patients in need of a safe and effective treatment for HPV positive cancers. Following FDA clearance of our IND, we look forward to advancing this promising combination of therapies into the clinic," said Mike Burgess, MD, Ph.D., president of Research and Development at Turnstone. "We are excited to have the support of Roche in evaluating our novel MG1 platform in combination with atezolizumab, and believe the promise of our technology to unleash the power of T cells to treat a range of solid tumors is reinforced by this relationship."

Turnstone’s MG1 virus is the first immunotherapy engineered to function as both a selective tumor-destroying oncolytic virus and an immune stimulating T cell vaccine. MG1 directly attacks cancer cells and modifies the microenvironment to make tumor sites throughout the body susceptible to targeted killer T cell responses, also induced by the virus. Building off of recently published scientific data, Turnstone will investigate MG1-HPV (MG1 expressing four different HPV viral antigens) as a safe and effective treatment option for patients with advanced metastatic cervical, oropharyngeal, and other HPV positive solid tumors.

On May 16, 2018 Verastem, Inc. (Nasdaq: VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, reported that five abstracts have been selected for poster presentations at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) being held June 1-5, 2018 in Chicago (Press release, Verastem, MAY 16, 2018, View Source;p=RssLanding&cat=news&id=2349503 [SID1234526720]).

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The Company will present data on its lead product candidate, duvelisib, a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, as well as defactinib, its oral small molecule inhibitor of Focal Adhesion Kinase (FAK). The poster presentations will highlight the latest findings from the Company’s ongoing clinical trials for duvelisib, the Phase 3 DUO study crossover extension in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), in addition to a Phase 1 study of defactinib in combination with pembrolizumab and gemcitabine in patients with relapsed/refractory pancreatic cancer.

A poster will also be presented on PRIMO, a Phase II study that Verastem Oncology has initiated to evaluate duvelisib monotherapy in peripheral T-cell lymphoma (PTCL), one of the most aggressive forms of non-Hodgkin lymphoma (NHL). The U.S. Food and Drug Administration (FDA) has granted fast track designation to the investigation of duvelisib for the potential treatment of patients with peripheral T-cell lymphoma (PTCL) who have received at least one prior therapy. This study was initiated based on promising activity observed with duvelisib monotherapy in T-cell lymphomas in the Phase I study. In addition, posters on biomarker measurements in the DUOTM and DYNAMOTM studies, as well as in a treatment naive follicular lymphoma study, will be presented.

"In the crossover extension trial of the Phase 3 DUO study, patients treated with duvelisib following confirmed disease progression on prior ofatumumab therapy exhibited a 73% overall response rate (ORR), compared to a 28% ORR with ofatumumab in the DUO study. These results were consistent with the ORR of patients originally initiated on duvelisib. This response rate was accompanied by a longer median progression-free survival (mPFS), with duvelisib-treated patients achieving 15-month mPFS, compared to 9 months when they were treated with ofatumumab," said Diep Le, MD, PhD, Chief Medical Officer of Verastem Oncology.

Dr. Le added, "For our lead FAK inhibitor defactinib, Dr. Andrea Wang-Gillam will describe initial results from the ongoing Phase 1 study evaluating defactinib in combination with pembrolizumab and gemcitabine in patients with advanced pancreatic cancer. In addition to defining a recommended Phase 2 dose, the combination regimen has been well tolerated with promising signs of clinical activity, including one confirmed partial response in a pancreatic cancer patient and stable disease in additional pancreatic patients."

"Data presented at this year’s ASCO (Free ASCO Whitepaper) meeting by Verastem Oncology and collaborative researchers also directly demonstrate inhibition of both PI3K-delta and PI3K-gamma in patients treated with duvelisib," said Jonathan Pachter, PhD, Chief Scientific Officer of Verastem Oncology. "Accordingly, biomarker changes observed in duvelisib-treated patients indicate targeting of malignant B-cells directly along with targeting of the supportive tumor microenvironment."

Details for the ASCO (Free ASCO Whitepaper) 2018 presentations are as follows:

Duvelisib

Title: The efficacy of duvelisib monotherapy following disease progression on ofatumumab monotherapy in patients with relapsed/refractory CLL or SLL in the DUO crossover extension study
Lead author: Dr. Bryone Kuss, Flinders Medical Center
Session: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Poster #: 170
Abstract #: 7533
Location: McCormick Place Hall A
Date and Time: Monday, June 4, 8:00 – 11:30 a.m. CT

Title: The effect of duvelisib, a dual inhibitor of PI3K-δ,γ, on components of the tumor microenvironment in previously untreated follicular lymphoma
Lead author: Dr. Carla Casulo, University of Rochester, Wilmot Cancer Center
Session: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Poster #: 216
Abstract #: 7579
Location: McCormick Place Hall A
Date and Time: Monday, June 4, 8:00 – 11:30 a.m. CT

Title: The PRIMO study: A phase 2 study of duvelisib efficacy and safety in patients with relapsed or refractory peripheral t-cell lymphoma (PTCL)
Lead author: Dr. Steven Horwitz, Memorial Sloan Kettering Cancer Center
Session: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Poster #: 222b
Abstract #: TPS7590
Location: McCormick Place Hall A
Date and Time: Monday, June 4, 8:00 – 11:30 a.m. CT

Title: Duvelisib inhibition of chemokines in patients with CLL (DUO study) and iNHL (DYNAMO study)
Lead author: Dr. David Weaver, Verastem Oncology
Session: Tumor Biology
Poster #: 161
Abstract #: 12048
Location: McCormick Place Hall A
Date and Time: Monday, June 4, 1:15 – 4:45 p.m. CT

Defactinib

Title: Phase I study of defactinib combined with pembrolizumab and gemcitabine in patients with advanced cancer
Lead author: Dr. Andrea Wang-Gillam, Washington University School of Medicine in St. Louis
Session: Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics
Poster #: 387
Abstract #: 2561
Location: McCormick Place Hall A
Date and Time: Monday, June 4, 8:00 – 11:30 a.m. CT

About Duvelisib

Duvelisib is a first-in-class investigational oral, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B- and T-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib was evaluated in late- and mid-stage extension trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL),4 and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL).5 Both DUO and DYNAMO achieved their primary endpoints. Verastem Oncology’s New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL) was accepted for filing by the U.S. Food and Drug Administration (FDA), granted Priority Review and assigned a target action date of October 5, 2018. Duvelisib is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), and is being investigated in combination with other agents through investigator-sponsored studies.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

About Defactinib

Defactinib is an investigational inhibitor of focal adhesion kinase (FAK), a non-receptor tyrosine kinase that mediates oncogenic signaling in response to cellular adhesion and growth factors.7 Based on the multi-faceted roles of FAK, defactinib is used to treat cancer through modulation of the tumor microenvironment and enhancement of anti-tumor immunity.8,9 Defactinib is currently being evaluated in three separate clinical collaborations in combination with immunotherapeutic agents for the treatment of several different cancer types including pancreatic cancer, ovarian cancer, non-small cell lung cancer (NSCLC), and mesothelioma. These studies are combination clinical trials with pembrolizumab and avelumab from Merck & Co. and Pfizer/Merck KGaA, respectively.10,11,12 Information about these and additional clinical trials evaluating the safety and efficacy of defactinib can be found on www.clinicaltrials.gov