On September 24, 2018 AstraZeneca and MedImmune, its global biologics research and development arm, reported that the European Commission has granted marketing authorisation for Imfinzi (durvalumab) as monotherapy for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT) (Press release, AstraZeneca, SEP 24, 2018, View Source [SID1234529611]). The approval is based on results from the Phase III PACIFIC trial.

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Dave Fredrickson, Executive Vice President, Head of the Oncology Business, said: "Patients in Europe diagnosed with locally-advanced, unresectable non-small cell lung cancer now have a new treatment option. Imfinzi is the only immunotherapy to be approved in this curative-intent setting, and we are proud to bring a new standard of care for this difficult disease."

Dr. Luis Paz-Ares, co-principal investigator of the PACIFIC trial, from the Hospital Universitario Doce de Octubre, Madrid, Spain, said: "Lung cancer is the leading cause of cancer-related death in Europe and approximately a third of European patients with NSCLC present with locally-advanced disease. For decades, the standard of care for these patients has been chemotherapy and radiation therapy followed by active surveillance, after which the majority of patients progress to advanced disease. Imfinzi has demonstrated a compelling survival benefit for these patients in this area of significant unmet need."

The approval follows the positive opinion on 27 July 2018 from the CHMP of the European Medicines Agency.

The most common adverse reactions (greater than or equal to 20% of patients) of Imfinzi versus placebo were cough (40.2% vs. 30.3%), upper respiratory tract infections (26.1% vs 11.5%) and rash (21.7% vs 12.0%). 12.8% of patients experienced a grade 3 or 4 AE with Imfinzi vs 9.8% with placebo.

Imfinzi is approved for the treatment of patients with unresectable, Stage III (locally-advanced) NSCLC in the US, Canada, Switzerland, India, Japan and Brazil. Other global health authority reviews and submissions are ongoing.

About Stage III NSCLC

Stage III (locally-advanced) NSCLC is divided into three sub-categories (IIIA, IIIB and IIIC), defined by how much the cancer has spread locally and the possibility of surgery. Stage III disease is different from Stage IV disease, when the cancer has spread (metastasised) to distant organs, as Stage III is currently treated with curative intent.

Stage III NSCLC represents approximately one-third of NSCLC incidence and was estimated to affect around 105,000 patients in the top-eight countries (China, France, Germany, Italy, Japan, Spain, UK, US) in 2017. The majority of Stage III NSCLC patients are diagnosed with unresectable tumours. No new treatments beyond chemoradiation therapy, followed by active surveillance to monitor for progression, have been available to patients for decades.

About PACIFIC

The PACIFIC trial is a Phase III, randomised, double-blinded, placebo-controlled, multi-centre trial of Imfinzi as treatment in ‘all-comer’ patients (i.e. regardless of PD-L1 status) with unresectable, Stage III (locally-advanced) NSCLC whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT).

The trial is being conducted in 235 centres across 26 countries involving 713 patients. The primary endpoints of the trial are PFS and OS, and secondary endpoints include landmark PFS and OS, objective response rate, and duration of response.

About Imfinzi

Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is approved for unresectable, Stage III NSCLC in the US, Canada, Switzerland, India, Japan, and Brazil based on the Phase III PACIFIC trial. Imfinzi is also approved for the treatment of patients with locally-advanced or metastatic urothelial carcinoma in the US, Canada, Brazil, Israel, Hong Kong, and India.

As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in combination with chemotherapy, radiation therapy, small molecules, and tremelimumab, an anti-CTLA4 monoclonal antibody, as a first or second-line treatment for patients with NSCLC, small-cell lung cancer, locally-advanced or metastatic urothelial carcinoma, head and neck cancer and other solid tumours.

On September 24, 2018 SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported that Angelos Stergiou, M.D., ScD h.c., President and Chief Executive Officer of SELLAS, will present a corporate overview at the 2018 Cantor Global Healthcare Conference on Monday, October 1, 2018 at 2:20 p.m. ET at the Intercontinental Barclay Hotel in New York, NY (Press release, Sellas Life Sciences, SEP 24, 2018, View Source [SID1234529564]).

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A live audio webcast of the presentation will be available under "Events & Presentations" in the Investors section of SELLAS’ website at www.sellaslifesciences.com/investors. A replay of the webcast will be available for up to 30 days on SELLAS’ website following the presentation.

On September 24, 2018 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development and commercialization of innovative therapeutics for the treatment of cancer, reported a change in leadership with the appointment of James E. Dentzer as President and Chief Executive Officer effective immediately Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development and commercialization of innovative therapeutics for the treatment of cancer, reported a change in leadership with the appointment of James E. Dentzer as President and Chief Executive Officer effective immediately. In addition, Mr. Dentzer will become a member of the Curis Board of Directors. He replaces Ali Fattaey, Ph.D., who is leaving the Company.

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Mr. Dentzer, who joined Curis in 2016, was promoted earlier this year to Chief Operating Officer to manage all functions outside of research and development, including business development, manufacturing, quality, human resources, finance, legal, IT, and investor and public relations. Mr. Dentzer is also leading the pre-commercial strategic planning for fimepinostat, which received Fast Track designation from the FDA earlier this year for the treatment of patients with Relapsed/Refractory DLBCL.

"The Curis board of directors appreciates the contributions of Dr. Fattaey in transforming Curis into a development-focused company with a pipeline of clinical-stage assets," said Martyn D. Greenacre, the Company’s Chairman. "We wish the best for Ali, who was key in the recruitment of Jim to Curis two years ago. As Chief Operating Officer, Jim has been a driver of the business operations of the Company, while bringing important perspective to the development of Curis’s strategic plan. Looking forward, we believe he is best positioned to lead Curis as we seek to progress our three high-value programs quickly and successfully through the clinic."

Mr. Dentzer brings more than 25 years of experience, including executive leadership roles at Dicerna Pharmaceuticals, Amicus Therapeutics, Valeritas, and Biogen. Mr. Dentzer earned a BA in philosophy from Boston College and MBA from the University of Chicago’s Booth School of Business.

. In addition, Mr. Dentzer will become a member of the Curis Board of Directors. He replaces Ali Fattaey, Ph.D., who is leaving the Company.

Mr. Dentzer, who joined Curis in 2016, was promoted earlier this year to Chief Operating Officer to manage all functions outside of research and development, including business development, manufacturing, quality, human resources, finance, legal, IT, and investor and public relations. Mr. Dentzer is also leading the pre-commercial strategic planning for fimepinostat, which received Fast Track designation from the FDA earlier this year for the treatment of patients with Relapsed/Refractory DLBCL.

"The Curis board of directors appreciates the contributions of Dr. Fattaey in transforming Curis into a development-focused company with a pipeline of clinical-stage assets," said Martyn D. Greenacre, the Company’s Chairman. "We wish the best for Ali, who was key in the recruitment of Jim to Curis two years ago. As Chief Operating Officer, Jim has been a driver of the business operations of the Company, while bringing important perspective to the development of Curis’s strategic plan. Looking forward, we believe he is best positioned to lead Curis as we seek to progress our three high-value programs quickly and successfully through the clinic."

Mr. Dentzer brings more than 25 years of experience, including executive leadership roles at Dicerna Pharmaceuticals, Amicus Therapeutics, Valeritas, and Biogen. Mr. Dentzer earned a BA in philosophy from Boston College and MBA from the University of Chicago’s Booth School of Business.

On September 24, 2018 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported updated results from the ongoing ENCORE 601 cohort enrolling non-small cell lung cancer (NSCLC) patients previously treated with both chemotherapy and PD-(L)1 therapy (Press release, Syndax, SEP 24, 2018, View Source [SID1234529562]). The oral presentation titled, "Efficacy/Safety of Entinostat (ENT) and Pembrolizumab (PEMBRO) in NSCLC Patients Previously Treated with Anti-PD-(L)1 Therapy," was presented by Matthew D. Hellman, M.D., study investigator and medical oncologist at Memorial Sloan Kettering Cancer Center, at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer (WCLC) in Toronto, Canada. A copy of the presentation is available via the Syndax website at View Source

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"The observation of durable responses seen with the entinostat-pembrolizumab combination in NSCLC patients previously treated with both chemotherapy and PD-(L)1 therapy is an important result, and we look forward to more fully characterizing patient selection tools to identify those who are most likely to respond," said Peter Ordentlich, Ph.D., Syndax co-founder and Chief Scientific Officer. "The exploratory finding that baseline peripheral classical monocytes may predict clinical benefit to the combination provides an opportunity to potentially correlate a readily measurable circulating biomarker with the state of the tumor microenvironment and supports the use of this approach for patient selection in future studies."

The Company previously presented a subset of data from the first 57 patients in the Phase 2 ENCORE 601 NSCLC cohort, which enrolled patients whose disease had progressed after prior chemotherapy and anti-PD-(L)1 treatment, at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting this past June. The updated data set presented today includes data from all 76 patients who enrolled in this cohort prior to the close of enrollment in December 2017, and highlights the durability of the observed responses independent of prior treatment history or PD-(L)1 status. At the time of data cut-off, there were 7 confirmed partial responses (PRs) among the overall population of 72 efficacy-evaluable patients, for a 10% objective response rate (ORR) (95% CI: 4-19%), a median duration of response of 5.3 months, and a median progression free survival (PFS) of 2.8 months. The results did not meet the prespecified ORR endpoint. Six of the 7 responders had low or negative PD-(L)1 expression at study entry. At the time of data cut-off, 6 patients remain on study. Updated data continue to demonstrate a manageable toxicity profile for the entinostat-pembrolizumab combination, with treatment emergent adverse events observed consistent with those previously reported.

Exploratory analysis of baseline biomarkers in the fully enrolled cohort supports the previous observation from the first 57 patients that elevated pre-treatment baseline levels of peripheral classical blood monocytes (CD14+CD16-HLA-DRhi) are associated with enhanced clinical benefit to the entinostat-pembrolizumab combination. Baseline peripheral classical monocyte data were available for 65 of the 72 NSCLC patients evaluable for efficacy and were divided into a group of high baseline monocytes ("monocyte high" n = 19) and low baseline monocytes ("monocyte low" n = 46). The monocyte high subset showed an improved median PFS (5.3 months vs 2.7 months), and an enhanced ORR (21% vs 7%), with 5 of 19 (26%) patients remaining on study compared to only 1 of 46 (2%) in the monocyte low group.

"We continue to remain encouraged by the consistent observation of enhanced clinical benefit in the subgroup of patients who failed prior PD-1 treatment and had high baseline levels of classical peripheral monocytes, a population for whom novel therapies are needed," said Briggs Morrison, M.D., Chief Executive Officer of Syndax. "We recognize the importance of identifying patients more likely to respond to treatment and believe that our updated classical monocyte dataset strengthens the rationale for further validation of this patient selection biomarker. We look forward to communicating our plans for entinostat in this indication in the fourth quarter."

E2112 Update

Syndax also announced today that ECOG-ACRIN Cancer Research Group has informed the Company that enrollment in the ongoing E2112 Phase 3 registration trial of entinostat plus exemestane in advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer is now scheduled to close in late October. The Company will release the results of the PFS analysis following its review, and anticipates communicating this in the fourth quarter. The trial remains ongoing, with interim overall survival (OS) analyses scheduled to occur every May and November until either the appropriate number of events are achieved or definitive interim results are obtained.

About Entinostat

Entinostat is a selective, oral, once-weekly inhibitor of class 1 HDACs, currently being evaluated in a pivotal Phase 3 clinical trial (E2112) in combination with exemestane for advanced hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer, an indication for which it has been granted Breakthrough Therapy Designation by the FDA. Entinostat has also been shown to block the function of immune suppressive cells in the tumor microenvironment, and is being evaluated in combination with several approved PD-1/PD-L1 antagonists, including in ongoing Phase 2 clinical trials combining entinostat with KEYTRUDA from Merck & Co., Inc. for non-small cell lung cancer, melanoma and colorectal cancer (ENCORE 601); with TECENTRIQ from Genentech, Inc. for triple negative breast cancer as well as advanced hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer (ENCORE 602); and with BAVENCIO from Pfizer Inc. and Merck KGaA, Darmstadt, Germany, for ovarian cancer (ENCORE 603).

On September 24, 2018 Heron Therapeutics, Inc. (NASDAQ: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics, will present at the 2018 Cantor Global Healthcare Conference on Monday, October 1, 2018, at 2:20 p.m. EDT at the Intercontinental New York Barclay Hotel (Press release, Heron Therapeutics, SEP 24, 2018, View Source [SID1234529561]).

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A live webcast of this presentation will be available on the Company’s website at www.herontx.com in the Investor Resources section. A replay of the presentation will be archived on the site for 60 days.