On March 1, 2019 Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that its Board of Directors declared a quarterly cash dividend of $0.53 per share, payable on April 22, 2019 to shareholders of record of Quest Diagnostics common stock on April 8, 2019 (Press release, Quest Diagnostics, MAR 1, 2019, View Source [SID1234533880]).

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On March 1, 2019 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that its Phase 3 FORWARD I trial evaluating the safety and efficacy of mirvetuximab soravtansine compared to chemotherapy in patients with folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer did not meet its primary endpoint of progression-free survival (PFS) in either the entire study population or in the pre-specified subset of patients with high FRα expression (Press release, ImmunoGen, MAR 1, 2019, View Source [SID1234533865]).

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"Even though FORWARD I did not meet its primary endpoint, I continue to be impressed with the efficacy and tolerability of mirvetuximab soravtansine in ovarian cancer patients, especially in the subset with high FRα expression," said Dr. Kathleen Moore, Associate Director of Clinical Research at the Stephenson Cancer Center at the University of Oklahoma. "I look forward to continuing to work with ImmunoGen to analyze the Phase 3 data and determine the most appropriate path to bringing mirvetuximab soravtansine to those patients who benefit most from it."

The FORWARD I Phase 3 trial randomized 366 patients 2:1 to receive either mirvetuximab soravtansine or the physician’s choice of single-agent chemotherapy (pegylated liposomal doxorubicin, topotecan, or weekly paclitaxel). Eligibility criteria included patients with platinum-resistant ovarian cancer that expressed medium or high levels of FRα who have been treated with up to three prior regimens. The primary endpoint of this study was PFS, which was assessed using the Hochberg procedure in the entire study population and in the subset of patients with high FRα expression. The Hochberg procedure enables the simultaneous testing of two overlapping populations. Under this statistical analysis plan, if the p-value of the primary endpoint in either population is greater than 0.05, the p-value in the other population needs to be less than or equal to 0.025 to achieve statistical significance.

"Based upon the efficacy signals we observed in the high FRα subset with PFS, confirmed overall response rate and overall survival, we are conducting additional analyses to further evaluate the potential benefit of mirvetuximab soravtansine for FRα-positive platinum-resistant ovarian cancer," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "We want to thank the patients who participated in this trial, the clinical investigators, and the support staff for their hard work, as we continue to pursue our goal of finding innovative cancer treatments for patients in need."

Key findings from FORWARD I are as follows:

In the entire study population, the confirmed overall response rate was higher for mirvetuximab soravtansine than for chemotherapy (22% vs 12%, p-value 0.015), without a significant difference in the primary endpoint of PFS (HR 0.98, p-value 0.897) or overall survival (HR 0.81, p-value 0.248).
In the pre-specified high FRα subgroup (218/366, 60%)
PFS was longer in patients who received mirvetuximab soravtansine compared with chemotherapy (HR 0.69, p-value 0.049). Given that the p-value in the entire study population exceeded 0.05, the statistical analysis plan for the study required the p-value in the high subset to be less than or equal to 0.025 to achieve statistical significance.
Confirmed overall response rate was higher for mirvetuximab soravtansine than for chemotherapy (24% vs 10%, p-value 0.014).
Overall survival was longer in patients who received mirvetuximab soravtansine compared with chemotherapy (HR 0.62, p-value 0.033).
Mirvetuximab soravtansine was well-tolerated, with fewer patients experiencing grade 3 or greater adverse events (46% vs 61%), fewer dose reductions (20% vs 31%), and fewer discontinuations due to drug-related adverse events (5% vs 8%) compared with chemotherapy.
The safety profile of mirvetuximab soravtansine was confirmed, with the most common adverse events including nausea (54% all grades; 2% grade 3 or greater), diarrhea (44% all grades; 4% grade 3 or greater), and blurred vision (43% all grades; 3% grade 3 or greater).
"This study with mirvetuximab did not result in the outcome that we had hoped for in platinum-resistant patients. We will further assess the data from FORWARD I to determine potential next steps with a monotherapy approach. In parallel, we have generated encouraging data with mirvetuximab combination regimens and will evaluate our ongoing studies as an independent path forward to support a registration in ovarian cancer," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "ImmunoGen is in a strong financial position with approximately $295 million in cash on our balance sheet, and we will continue to advance our portfolio of next-generation ADCs, which includes three additional development candidates targeting a range of tumor types in both hematologic malignancies and solid tumors."

ImmunoGen intends to present additional results from FORWARD I at an upcoming medical meeting.

CONFERENCE CALL INFORMATION
ImmunoGen will host a conference call on March 1, 2019 at 8 a.m. ET to discuss the top-line findings from the FORWARD I trial. To access the live call by phone, dial 334-323-0522; the conference ID is 7188781. The call may also be accessed through the "Investors and Media" section of the Company’s website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through March 15.

ABOUT FORWARD I
FORWARD I is a Phase 3 trial in which 366 patients were randomized 2:1 to receive either mirvetuximab soravtansine or the physician’s choice of single-agent chemotherapy (pegylated liposomal doxorubicin, topotecan, or weekly paclitaxel). Eligible patients were diagnosed with platinum-resistant ovarian cancer that expresses medium or high levels of FRα and were treated with up to three prior regimens. The primary endpoint of this study was progression free survival (PFS), which was assessed in the entire study population and in the subset of patients with high FRα expression. ImmunoGen estimates that 12,000-14,000 patients per year in the U.S. meet these criteria, with a comparable number in the major markets in Europe.

ImmunoGen partnered with the GOG Foundation Inc., a leader in clinical research in gynecologic malignancies, on FORWARD I, which was conducted in North America and Europe. This trial was intended to support full marketing approval of mirvetuximab soravtansine for patients with platinum-resistant ovarian cancer.

ABOUT MIRVETUXIMAB SORAVTANSINE
Mirvetuximab soravtansine (IMGN853) is the first folate receptor alpha (FRα)-targeting ADC. It uses a humanized FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.

On March 1, 2019 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and leader in predictive target discovery, reported that its Phase 1 clinical trial evaluating COM701, a first-in-class therapeutic antibody targeting PVRIG, was featured in a trial-in-progress at The ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium (Press release, Compugen, MAR 1, 2019, View Source [SID1234533881]). In poster titled "A Phase 1 Study Evaluating COM701 in Patients With Advanced Solid Tumors," the Company reported that the third single subject dose cohort has been completed with no dose-limiting toxicities (DLTs) reported. Clinical and laboratory assessment for safety and tolerability is ongoing for the fourth dosing cohort. The poster presented at the symposium is available on Compugen’s website.

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"We continue to see significant interest in the study from investigators as they recognize the potential and differentiation of COM701 relative to other checkpoint inhibitors in development," said Henry Adewoye, M.D., Chief Medical Officer at Compugen. "After recently adding Massachusetts General Hospital and the University of Chicago, two additional leading medical centers with significant experience in immuno-oncology, we now have five sites recruiting patients for this Phase 1 study. Patient enrollment is also on track and we expect to complete enrollment of both the monotherapy and dual combination dose escalation arms of the study this year."

The sites currently recruiting patients are: The START center in San Antonio, Texas; The University of Tennessee West Cancer Center in Memphis, Tennessee; Sarah Cannon Research Institute in Nashville, Tennessee; Massachusetts General Hospital in Boston, Massachusetts; and the University of Chicago in Chicago, Illinois. The study is expected to include up to ten sites and enroll approximately 140 patients.

Updated information on the COM701 Phase 1 clinical study will be next featured in a trial-in-progress poster at The AACR (Free AACR Whitepaper) Annual Meeting 2019 taking place March 29-April 3, 2019 at the Georgia World Congress Center, Atlanta, GA.

About the COM701 Phase 1 Study

This Phase 1 open-label clinical trial is designed to assess the safety and tolerability of administering escalating doses of COM701 monotherapy as well as combination administration with a PD-1 inhibitor in patients with advanced solid tumors. Additionally, the trial will evaluate evidence of preliminary antitumor activity of COM701 as a monotherapy as well as in combination with a PD-1 inhibitor in patients with selected tumor types, including non-small cell lung cancer, ovarian cancer, breast cancer and endometrial cancer. Additional information is available here.

On March 1, 2019 AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, reported that the Company will be presenting mechanism of action findings and study design details at the 2019 ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium taking place February 28 to March 2 in San Francisco, CA (Press release, AIVITA Biomedical, MAR 1, 2019, View Source [SID1234533882]). Chief Science Officer Dr. Gabriel Nistor will present a poster concerning Th17 responses to an autologous immunotherapy targeting cancer stem cells. Chief Medical Officer Dr. Robert O. Dillman will present a poster concerning AIVITA’s randomized Phase 2 trial of patient-specific immunotherapy targeting cancer stem cells.

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The ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium is a three-day meeting focused on clinical and translational research in immune-oncology. Dr. Nistor’s poster presentation will take place March 1 in Poster Session B of the Melanoma/Skin Cancers track. It will highlight how an autologous cancer immunotherapy can induce a Th17 phenotype preceding a Th1 type response. The findings are important for applications in settings in which tumor infiltration with Th17+ cells correlate with survival, such as in advanced ovarian cancer.

Dr. Dillman’s poster presentation will take place March 1 in Poster Session B of the Breast and Gynecologic Cancers track. It will inform attendees of the design and methodologies of AIVITA’s active Phase 2 clinical trial for ovarian cancer. The trial was initiated in November 2017 at a single site and has thus far received 11 appropriate patient tumor samples, with all 11 having successfully been expanded into viable cell lines for use in the creation of the Company’s autologous vaccine. Additional clinical sites are being initiated.

AIVITA is currently conducting three clinical studies investigating its platform ROOT OF CANCER therapy in patients with ovarian cancer, glioblastoma and melanoma. AIVITA uses 100% of proceeds from the sale of its ROOT of SKIN skincare line to support the treatment of women with ovarian cancer.

About ROOT OF CANCER

AIVITA’s treatment is a platform technology applicable to most solid tumor types and consists of autologous dendritic cells loaded with autologous tumor antigens from purified autologous self-renewing tumor-initiating cells.

AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous cancer stem cell-targeting immunotherapy or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy.

For additional information about AIVITA’s AVOVA-1 trial patients can visit: www.clinicaltrials.gov/ct2/show/NCT02033616

AIVITA’s glioblastoma Phase 2 single-arm study is active and is enrolling approximately 55 patients to receive the cancer stem cell-targeting immunotherapy.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC).

For additional information about AIVITA’s AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917

AIVITA’s melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with the cancer stem cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients.

Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.

For additional information about AIVITA’s AV-MEL-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03743298

On March 1, 2019 CARsgen Therapeutics, a clinical-stage company committed to developing Chimeric Antigen Receptor T cell therapies for cancer, reported that one of its leading drug candidates, CT053 fully human BCMA (B-Cell Maturation Antigen)-CAR-T cell for the treatment of patients suffering from relapsed/refractory multiple myeloma (rrMM), has received Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) (Press release, Carsgen Therapeutics, MAR 1, 2019, View Source [SID1234533883]).

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"At the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in December 2018, our collaborator, Dr. Songfu Jiang presented encouraging safety and efficacy data in patients with rrMM who received CT053 BCMA-CAR-T cells. The IND clearance of BCMA-CAR-T cells by China’s NMPA is of great significance to CARsgen," said Dr. Zonghai Li, founder, CEO and CSO of CARsgen. "According to JAMA Oncology, in 2016, there were about 130,000 cases of myeloma, which means from 1990 to 2016, incident cases of myeloma increased by 126% globally[1] and despite the development of novel therapies, multiple myeloma remains incurable and new treatment options are needed. As part of the CT053 development plan, we also intend to submit an IND application for BCMA-CAR-T cells to the U.S. FDA in 2019. Our goal is to continue the development of novel, safe and effective immunotherapies. This is our long-standing commitment to cancer patients worldwide."