On June 1, 2019 TG Therapeutics presented the corporate presentation (Presentation, TG Therapeutics, JUN 1, 2019, View Source [SID1234537863]).

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On June 1, 2019 Novartis reported statistically significant overall survival (OS) results for Kisqali in combination with endocrine therapy[1]. The Phase 3 MONALEESA-7 trial evaluated Kisqali plus endocrine therapy (goserelin plus either an aromatase inhibitor or tamoxifen) as initial treatment compared to endocrine therapy alone in pre- and perimenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer[1]. MONALEESA-7 overall survival results will be featured in a press briefing today, presented as a late-breaker at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Abstract# LBA1008), and will be published in The New England Journal of Medicine.

The significant extension in survival met the early efficacy stopping criteria at a pre-specified interim analysis following 192 deaths (median OS, not reached vs. 40.9 [95% CI: 37.8-NE] months; HR=0.712 [0.535-0.948]; p=0.00973). Overall survival rates in the intent-to-treat population (n=672) at 42 months were 70.2% for Kisqali combination therapy compared to 46.0% for endocrine therapy alone. At the time of data cut-off, 35% of women taking Kisqali combination therapy were continuing the treatment. No new safety signals were observed[1]. Kisqali is not indicated for use with tamoxifen.

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"Overall survival benefit is considered the ‘gold standard’ in cancer trials but is challenging to achieve in HR+/HER2- metastatic breast cancer. MONALEESA-7 reached this important endpoint earlier than anticipated," said Sara Hurvitz, MD, Medical Director of the Jonsson Comprehensive Cancer Center Clinical Research Unit and Director of the Breast Cancer Clinical Trials Program at UCLA. "Impactful results like these ribociclib findings are what we wish for in every clinical trial, and to achieve overall survival improvement in an incurable disease, like metastatic breast cancer, is truly an outstanding advancement for patients."

Susanne Schaffert, Ph.D., CEO, Novartis Oncology, added, "Kisqali is the only CDK4/6 inhibitor to achieve statistically significant overall survival benefit in combination with endocrine therapy, and we are so proud to share these powerful data with the medical and patient community. These exciting results add to the proven efficacy and safety profile of Kisqali, solidify it as a standard of care for people living with HR+/HER2- metastatic breast cancer and inspire us to continue to reimagine medicine."

Results from subgroup analyses showed that Kisqali plus an aromatase inhibitor demonstrated a 30.0% reduced risk of death compared to an aromatase inhibitor alone (median OS not reached vs. 40.7 months [37.4-NE]; HR=0.699 [0.501-0.976]), and Kisqali plus tamoxifen demonstrated a 20.9% reduced risk of death compared to tamoxifen alone (HR=0.791 [0.454-1.377])[1]. Kisqali is not indicated for use with tamoxifen. In the MONALEESA-7 primary analysis, increase in QTcF was on average greater and equal to 10 milliseconds in people taking tamoxifen plus placebo compared those taking aromatase inhibitor and placebo[4].

"Kisqali has characteristics that make it distinct from other CDK4/6 inhibitors. For one, Kisqali shows especially strong inhibition against CDK4. In pre-clinical data, Kisqali is four- to five-fold more potent against CDK4 compared to CDK6. CDK4 is likely the dominant CDK in breast cancer and a pivotal driver of disease progression," said Jeff Engelman, MD, Global Head of Oncology Research, Novartis Institutes for BioMedical Research.

MJ DeCoteau, Executive Director of Rethink Breast Cancer, said, "Younger women living with advanced breast cancer encounter unique challenges as they face an incurable illness at the prime of their lives – they may be students, new moms or just embarking on their careers. Breast cancer is the leading cause of cancer death in women 20-59, so knowing an approved treatment has been proven to help them live longer is an outstanding advancement and provides new hope for women with this devastating disease."

About Kisqali (ribociclib)
Kisqali (ribociclib) is the CDK4/6 inhibitor with the largest body of first-line clinical trial evidence demonstrating consistent and sustained efficacy compared to endocrine therapy alone[5]. Kisqali is the only targeted therapy, including CDK4/6 inhibitors, in combination with endocrine therapy to demonstrate significantly longer overall survival compared to endocrine therapy alone as initial endocrine-based treatment for advanced breast cancer in the MONALEESA-7 trial[5]. Overall survival follow-up is ongoing for the Phase III MONALEESA-2 and MONALEESA-3 trials.

Novartis is continuing to reimagine cancer by investigating Kisqali in early breast cancer. The NATALEE study is a Phase III clinical trial of Kisqali with endocrine therapy in the adjuvant treatment of HR+/HER2- early breast cancer being conducted in collaboration with Translational Research In Oncology (TRIO)[5].

Kisqali is approved for use in more than 75 countries around the world, including the United States and European Union member states. Kisqali was initially approved by the US Food and Drug Administration (FDA) in March 2017 and by the European Commission (EC) in August 2017, as initial endocrine-based therapy for postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer in combination with an aromatase inhibitor based on findings from the pivotal MONALEESA-2 trial. Kisqali in combination with an aromatase inhibitor was approved for the treatment of pre-, peri- or postmenopausal women as initial endocrine based therapy, and also indicated for use in combination with fulvestrant as both first- or second-line therapy in postmenopausal women by the FDA in July 2018 and by the EC in December 2018. Regulatory filings are underway with other health authorities worldwide[5].

Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals[5].

On June 1, 2019 TG Therapeutics presented the corporate presentation (Presentation, TG Therapeutics, JUN 1, 2019, View Source [SID1234537864]).

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On June 1, 2019 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported results showing that circulating EBV-targeted cytotoxic T lymphocyte precursors (EBV-CTLp) could serve as a biomarker of clinical response to tab-cel (tabelecleucel) in patients with EBV-driven diseases (Press release, Atara Biotherapeutics, JUN 1, 2019, View Source [SID1234536745]). Findings were presented today at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2019 in Chicago.

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Ten tab-cel-treated patients with EBV-associated diseases from a multicenter expanded access protocol (EAP) study were selected. In this cohort, ex-vivo analyses of circulating EBV-CTLp following administration of tab-cel showed a statistically significant correlation (p=0.038) with clinical response.

A second presentation described the design of an ongoing Phase 1b/2 clinical study of tab-cel in combination with pembrolizumab for patients with platinum-resistant or recurrent EBV-associated nasopharyngeal carcinoma (NPC). Tab-cel has been evaluated as a single agent in previous studies where evidence of radiographic response was observed in patients with chemotherapy refractory, metastatic NPC.

Abstract 2532: Correlation of circulating EBV-targeted cytotoxic T lymphocyte precursors (EBV-CTLp) and clinical response following tabelecleucel (tab-cel) infusion in patients with EBV-driven disease
Poster Presentation Date and Time: Saturday, June 1, 2019, 8:00 a.m. – 11:00 a.m. CDT
Session Title: Developmental Immunotherapy and Tumor Immunobiology
Location: Poster Board 176, Hall A, McCormick Place, South Building, Chicago, IL
Authors: Blake T. Aftab, Daniel Munson, Kevin Rasor, Philippe Foubert, Donald Tsai, Wen Kai Weng, Armin Ghobadi, Koen van Besien, Yan Sun, Minoti Hiremath, Willis Navarro, Susan Prockop
Affiliations: Atara Biotherapeutics, University of Pennsylvania, Stanford University, Washington University, Cornell University, Memorial Sloan Kettering Cancer Center

Abstract TPS6092: Tabelecleucel in combination with pembrolizumab (Pembro) in platinum-pretreated, recurrent/metastatic Epstein-Barr virus (EBV)-positive nasopharyngeal carcinoma (EBV+NPC)
Poster Presentation Date and Time: Saturday, June 1, 2019, 1:15 p.m. – 4:15 p.m. CDT
Session Title: Head and Neck Cancer
Location: Poster Board 79b, Hall A, McCormick Place, South Building, Chicago, IL
Authors: Lillian L. Siu, Joshua Bauml, Douglas Adkins, A. Dimitrios Colevas, Cesar Perez, Jennifer Choe, Yang Zhang, Wen Shi, Willis Navarro, Missak Haigentz Jr, Guilherme Rabinowits, David Pfister
Affiliations: Princess Margaret Cancer Centre, Perelman School of Medicine, Washington University School of Medicine, Stanford Cancer Institute, Sylvester Comprehensive Cancer Center, Duke University, Atara Biotherapeutics, Morristown Medical Center/Atlantic Health System, Miami Cancer Institute, Memorial Sloan Kettering Cancer Center

About EBV+ NPC
Nasopharyngeal carcinoma (NPC) is a head and neck cancer that is primarily EBV-associated. Historical median survival rates are less than one year for patients with metastatic disease. There are no approved targeted therapies for NPC available today.

On June 1, 2019 Rakuten Medical, a clinical-stage biotechnology company developing precision-targeted cancer therapies based on its proprietary Photoimmunotherapy (PIT) platform, reported positive data results from its Phase 2a study, evaluating the safety and anti-tumor activity of RM-1929 (an EGFR-targeted antibody conjugate) PIT in patients with locoregional, recurrent head and neck squamous cell carcinoma (rHNSCC) (Press release, Rakuten Aspyrian, JUN 1, 2019, View Source [SID1234536761]). Details of its global Phase 3 study trial design were also presented.

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The Phase 2a positive data, presented during a poster presentation discussion during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago on Saturday, June 1, 2019, showed that treatment with RM-1929 PIT resulted in clinically meaningful activity in 30, heavily pre-treated patients with rHNSCC.

The overall response rate by independent review was 43 percent (95 percent CI 25.5‒62.6), including four (13 percent) complete responses and nine (30 percent) partial responses.
The median, progression-free survival was 5.2 months (95 percent CI 2.1‒5.5), and median overall survival was 9.3 months (95 percent CI 5.2‒16.9).
Treatment with RM-1929 PIT was generally well-tolerated.
Out of the 13 patients (43.3 percent) who experienced a serious adverse event, only three (10 percent) were considered treatment-related.
"Rakuten Medical is committed to addressing the unmet medical needs of patients with cancer, and we are encouraged by the Phase 2a trial data, which demonstrated clinically meaningful anti-tumor activity in patients with late-stage head and neck cancer," said Jeannie Hou, VP of Clinical Development at Rakuten Medical. "We look forward to enrolling patients in our global Phase 3 trial in head and neck cancer."

Phase 3 Trial Overview
Rakuten Medical has initiated its Phase 3, multicenter, randomized, double-arm, open-label trial of ASP-1929 (an EGFR-targeted antibody conjugate; analogous to RM-1929) PIT versus a physician’s choice of standard-of-care for locoregional rHNSCC patients who have failed after at least two lines of therapy, of which at least one line must be systemic, platinum-based chemotherapy for HNSCC.

An overview of the trial background, design and criteria was also presented at ASCO (Free ASCO Whitepaper) during a poster session. The primary endpoints of the study are progression-free survival and overall survival, with the key secondary endpoint being objective response rate. Rakuten Medical expects to enroll approximately 275 patients in the U.S., EU and Asia Pacific.

For more information about the Phase 3 clinical trial (NCT03769506), visit www.clinicaltrials.gov.

About Photoimmunotherapy
Photoimmunotherapy (PIT) is an investigational, anti-cancer treatment platform that is comprised of a drug and device combination that utilizes monoclonal antibodies conjugated to a dye (IRDye 700DX). Transient excitation of IRDye 700Dx with non-thermal red light (690 nm) is believed to result in anti-cancer activity, which is mediated by biophysical processes that may compromise the membrane integrity of cells. The requirement of targeted binding of antibody-IR700 conjugate to a specific antigen on the cell surface and subsequent illumination is believed to result in rapid and selective cell killing and tumor necrosis with minimal effects on surrounding normal tissue. PIT may also lead to the systemic induction of innate and adaptive immunity.