On October 19, 2018 Incyte (NASDAQ:INCY) reported Phase 2 preliminary results of the GEOMETRY mono-1 clinical trial of investigational MET inhibitor capmatinib in 94 adult patients with advanced non-small cell lung cancer (NSCLC) harboring MET exon-14 skipping mutations (Press release, Incyte, OCT 19, 2018, View Source [SID1234529977]). The GEOMETRY mono-1 study showed an overall response rate (ORR) of 72.0 percent (95% CI: 50.6-87.9) in treatment-naive patients and 39.1 percent (95% CI: 27.6-51.6) in previously treated patients. ORR was assessed by blinded independent review committee (BIRC). Adverse events (AEs) were consistent with previously reported data and no new safety signals were observed.

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Results of the Novartis-sponsored Phase 2 study were presented today at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress (October 19, 2018 at 4:45 p.m. CEST / 10:45 a.m. EDT, Abstract LBA52).1

"These preliminary findings reveal the potential of capmatinib in MET exon-14 skipping mutated NSCLC patients. Compared to the previously treated patient groups, the primary advantage in terms of overall response rate reported in treatment-naive patients highlights the clinical relevance for an earlier diagnostic testing and prompt treatment of this challenging patient population," said Juergen Wolf, M.D., University Hospital Cologne, Germany.

NSCLC is the most common type of lung cancer, impacting more than 2 million people per year.2 Approximately 3-4 percent of all patients with NSCLC have an identified MET mutation.3 Though rare, this mutation is an indicator of especially poor prognosis and there is currently no approved therapy designed to target this mutation.4

"We are very pleased to announce these promising, preliminary results for capmatinib, another investigational medicine invented at Incyte that has the potential to be the first MET-selective targeted agent approved by the FDA," said Steven Stein, M.D., Chief Medical Officer, Incyte. "We are encouraged by the results of this study and the potential for capmatinib to help patients with advanced MET mutated NSCLC, who face a poor prognosis and represent a clear unmet medical need."

About GEOMETRY mono-1

The GEOMETRY mono-1 trial is a multicenter, open-label, Phase 2 study to evaluate the efficacy and safety of single-agent capmatinib (INC280) in adult patients with EGFR wildtype, ALK-negative rearrangement, advanced NSCLC harboring MET amplification and/or mutations. Patients with MET exon-14 skipping were assigned to Cohorts 4 (previously treated patients) or 5B (treatment naive) regardless of MET amplification/gene copy number (centrally confirmed), and received 400 mg capmatinib tablets twice daily. The primary endpoint was ORR based on BIRC assessment per RECIST v1.1. The key secondary endpoint was duration of response (DOR) by BIRC. The GEOMETRY mono-1 study found an ORR in the treatment-naive patients (n=25) of 72.0 percent (95% CI: 50.6-87.9) and an ORR in the previously treated patients (n=69) of 39.1 percent (95% CI: 27.6-51.6). DOR was not reached by the time of analysis, indicating sustainability of response.1,6

The most common treatment-related AEs included peripheral edema, nausea, vomiting and increased blood creatinine levels. Of patients treated with capmatinib, 83.8 percent experienced an AE, with 33.1 percent having grade 3/4 AEs.1,6

About Capmatinib

Capmatinib (INC280) is an investigational, oral and selective MET inhibitor invented at Incyte that was licensed to Novartis in 2009. Under the Agreement, Incyte granted Novartis exclusive development and commercialization worldwide rights to this MET inhibitor compound and certain back-up compounds in all indications. Novartis has stated that it expects to submit a new drug application to the U.S. Food and Drug Administration for capmatinib as a treatment for patients with advanced non-small cell lung cancer (NSCLC) harboring MET amplification and/or mutations in 2019. If capmatinib is successfully developed by Novartis, Incyte may become eligible for over $500 million in future milestones as well as royalties of between 12 percent and 14 percent on global sales by Novartis.

On October 19, 2018 SELLAS Life Sciences Group Inc., (Nasdaq: SLS) (SELLAS or the Company), a clinical-stage biopharmaceutical company focused on novel cancer immunotherapies for a broad range of cancer indications, reported that the independent Data Safety Monitoring Board (DSMB) unanimously concluded that the final data from the Phase 2b study of trastuzumab (TZ, Herceptin) +/- nelipepimut-S (NPS, NeuVax) in HER2 1+/2+ breast cancer patients confirms the previously announced findings from the interim analysis of this study (Press release, Sellas Life Sciences, OCT 19, 2018, View Source [SID1234529976]). The DSMB concluded that there was an incremental improvement in the outcomes and statistics with a longer median follow-up (more than 7 months; 26.1 months at final vs. 18.8 months at interim analysis). The final analysis showed no new safety signals and continued to show no difference in cardiotoxicity between TZ + NPS compared to TZ alone. Finally, the DSMB confirmed that the final analysis continues to identify patients with triple negative breast cancer (TNBC) as the key target patient population for development of the NPS + TZ combination in the adjuvant setting in early-stage HER2 1+/2+ breast cancer patients.

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On March 28, 2018, based on a pre-specified interim analysis and the positive TNBC results, the DSMB had recommended to expeditiously seek regulatory guidance by the U.S. Food and Drug Administration (FDA) for further development of the combination of NPS + TZ in TNBC, a population with large unmet medical need.

SELLAS will host a conference call at 8:00 a.m. ET on October 22, 2018, following the oral presentation at the ESMO (Free ESMO Whitepaper) 2018 Annual Meeting of the interim and updated final clinical data from its Phase 2b trial of the combination of trastuzumab (Herceptin) +/- nelipepimut-S (NPS, NeuVax) targeting HER2 low-expressing breast cancer patient cohorts. Management and invited Key Opinion Leaders, Dr. Elizabeth Mittendorf, MD, PhD and Dr. George Peoples, MD, FACS, will participate in the conference call.

Conference Call Details for Monday, October 22, 2018 at 8:00 a.m. ET:

To participate in the conference call, please dial (866) 416-7995 (domestic) or +1 (409) 217-8225 (international) and refer to conference ID 5571389. A live webcast of the call can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.sellaslifesciences.com.

An archived webcast recording will be available on the SELLAS website beginning approximately two hours after the call.

Details for the ESMO (Free ESMO Whitepaper) presentation are as follows:
Title:Pre-specified interim analysis of a randomized phase 2b trial of trastuzumab + nelipepimut-S (NeuVax) vs trastuzumab for the prevention of recurrence demonstrates benefit in triple negative (HER2 low-expressing) breast cancer patients
Date and Time: 22 October, 2018; 11:54 am Central European Time (5:54 am ET)
Location: Hall A2 – Room 18; Messe Munich Congress Venue, Munich, Germany

Herceptin is a registered trademark of Genentech, Inc. and is not a trademark of SELLAS. The manufacturer of this brand is not affiliated with and does not endorse SELLAS or its products.

About ESMO (Free ESMO Whitepaper)

The European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) is Europe’s leading non-profit medical oncology organization. ESMO (Free ESMO Whitepaper) is a membership-based society, comprising of 500 expert committee members and 18,000 oncology professionals. ESMO (Free ESMO Whitepaper) organizes a large number of meetings to provide its members and the community with the resources they need and also plays a major role in public policy and European affairs. The ESMO (Free ESMO Whitepaper) 2018 Annual Meeting represents a multi-professional platform for oncology education and exchange, and for immense international visibility for scientific research, and will be held under the tagline "Securing access to optimal cancer care."

On October 19, 2018 ArQule, Inc. (Nasdaq:ARQL) reported the presentation of preliminary clinical data on miransertib (ARQ 092) in three poster presentations at the American Society of Human Genetics (ASHG) 2018 Annual Meeting held from October 16 to 20, 2018 in San Diego (Press release, ArQule, OCT 19, 2018, View Source [SID1234529975]). The data presented relate to patients affected by either Proteus syndrome or PROS who have been receiving miransertib as part of a clinical trial or in a compassionate use setting.

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Two presentations feature data from two patients treated as part of ArQule’s named patient/compassionate use program. Presentation highlights include:

1.Personalized medicine in rare diseases and cancer: A case report of a lasting response in a young teenage patient with Proteus syndrome and secondary ovarian cancer

Treatment for the Proteus syndrome patient with concomitant relapsed ovarian cancer was administered at a dose level of 100mg and was well tolerated for over 19 months, resulting in a clinically significant/durable partial response of tumor and improvement of Proteus syndrome symptoms including improved mobility/bone changes
2.Severe PI3Kinase overgrowth syndrome treated with the AKT inhibitor miransertib

Treatment for the PROS patient was well tolerated for over 25 months resulting in clinical stabilization and radiological improvement of disease
"Our understanding of the potential for miransertib to target and treat these rare and devastating diseases that arise due to genetic alterations of the PI3K/AKT pathway has grown significantly since we partnered with The National Human Genome Research Institute in 2015 to conduct the first clinical trial in Proteus syndrome," said Brian Schwartz, M.D., Chief Medical Officer of ArQule. "The data we are presenting at ASH (Free ASH Whitepaper)G continues to highlight the promise of ArQule’s precision medicine approach for both rare diseases and oncology. We remain deeply committed to advancing miransertib for rare PI3K/AKT pathway overgrowth diseases as rapidly as possible, as there are currently no approved therapeutics for these patients."

A third presentation features data from patients treated as part of ArQule’s ongoing Phase 1/2, open label study of miransertib for the treatment of PROS. Study objectives include the evaluation of dosing schedule, safety, PK profile and preliminary efficacy of miransertib. Presentation highlights include:

3.An open-label, phase 1/2 study of miransertib (ARQ 092), an oral pan-AKT inhibitor, in patients (pts) with PIK3CA-related Overgrowth Spectrum (PROS): Preliminary results

Preliminary evidence of clinical efficacy was demonstrated by improvements in disease related symptoms and objective radiologic and photographic measures
Miransertib was well tolerated with a demonstrated manageable toxicity profile in patients as young as two years old
The recommended dose of miransertib, defined as 15 mg/m2 QD, with potential dose escalation to 25 mg/m2 QD, provided appropriate inhibition of the activated PIK3CA pathway for long-term use without inhibition of growth in normal healthy cells
Peter Lawrence, President and Chief Operating Officer of ArQule said: "This initial presentation of clinical data from our Phase 1/2 study in PROS lays the foundation for potentially expanding the miransertib rare disease program beyond Proteus syndrome, for which the drug already has received Rare Pediatric Disease and Fast Track Designation. We look forward to continuing our productive discussions with regulators to define a pivotal trial design and rapidly advance miransertib."

All posters presented by ArQule at the ASH (Free ASH Whitepaper)G 2018 Annual Meeting are available on the company’s website at View Source

About Miransertib
Miransertib (ARQ 092) is an orally available, selective, pan-AKT (protein kinase B) inhibitor that potently inhibits AKT1, 2 and 3 isoforms. Dysregulation of AKT has been implicated in a variety of rare overgrowth diseases and cancers; however, there are currently no approved inhibitors of AKT. AKT inhibitors, either as single agent or combination therapy, show significant promise in molecularly defined patient populations. Miransertib is currently in a Phase 1/2 company-sponsored study for PIK3CA-Related Overgrowth Spectrum (PROS), a Phase 1 study for ultra-rare Proteus syndrome conducted by the National Institutes of Health (NIH/NHGRI), and a Phase 1b study in combination with the hormonal therapy, anastrozole, in patients with advanced endometrial cancer with AKT and PI3K mutations. Miransertib has been granted Rare Pediatric Disease Designation and Fast Track Designation by the U.S. Food and Drug Administration (FDA), as well as Orphan Designation by the FDA and European Medicines Agency in the rare overgrowth disease, Proteus syndrome.

About PROS
PROS is a term used to refer to a spectrum of rare diseases identified by somatic mutations in the PIK3CA gene, that result in excess growth in certain areas of the body. While the individual diseases that fall within the overgrowth spectrum have similar symptoms, each disease is defined by unique clinical characteristics. The implementation of genetic sequencing has led to the identification of the underlying genetic mutations that drive these overgrowth disorders, allowing for the development of medicines that target the specific causes of disease.

About Proteus Syndrome
Proteus syndrome is an ultra-rare condition characterized by the aberrant overgrowth of multiple tissues of the body. Patients with Proteus syndrome experience changes in the shapes of certain body structures over time, including abnormal, often asymmetric, massive growth (overgrowth) of the skeleton, skin, adipose tissue and central nervous system out of proportion to the rest of the body. Although patients may have minimal or no manifestations at birth, the disease develops and becomes apparent in early childhood (6-18 months) and rapidly progresses with intense growth in the first 10 years of life. The worldwide incidence is believed to be approximately one in a million. There are currently no approved medicinal treatments for Proteus syndrome, leaving patients with minimal treatment options to manage the disease and a mortality of 25% by age 22.

On October 19, 2018 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported it will present at The Cellular "Living Drug" Revolution Summit being held next Thursday, October 25, 2018, at 6:00 PM, ET in New York City (Press release, Heat Biologics, OCT 19, 2018, View Source [SID1234529974]). John Prendergast, PH.D., Heat’s Lead Independent Director, will be presenting on the panel.

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The event brings executives from leading cell therapy companies together to discuss where the industry is headed and how their companies, individually and collectively, are helping advance the industry into a new era. Investors interested in attending the event can register at: https://investmentstrategiesinanewmedi.splashthat.com/

On October 19, 2018 – Novartis reported presentation of a new analysis of Lutathera (lutetium Lu 177 dotatate*) NETTER-1 data at the 2018 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) congress examining the impact of Lutathera treatment on patients with low, medium or high liver tumor burden (Press release, Novartis, OCT 19, 2018, View Source [SID1234529967]). The data show that Lutathera treatment results in significant improvement in progression free survival (PFS) regardless of the extent of baseline liver tumor burden (LTB), elevated alkaline phosphatase (ALP) liver enzyme or presence of large (>30mm diameter) lesion in patients with progressive midgut neuroendocrine tumors (NETs) compared to octreotide LAR alone[1].

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Lutathera is the first Peptide Receptor Radionuclide Therapy (PRRT) to receive regulatory registration, with approval by the European Commission in September 2017 and by the US Food and Drug Administration (FDA) in January 2018. Lutathera is an Advanced Accelerator Applications product.

"Patients with metastatic midgut NET and a high liver tumor load at diagnosis have a poorer prognosis than patients with few liver metastases[2],[3]," said Jonathan Strosberg, MD, Associate Professor, Section Head, Neuroendocrine Tumor Program at Moffitt Cancer Center, and Principle Investigator of the NETTER-1 study. "These new data provide hope for these patients and reinforce the potential benefit of Lutathera treatment in this population."

Liver tumor burden (LTB) was defined as tumor volume/total liver volume by CT or MRI, and categorized as low (<25%), moderate (25-50%), and high (>50%)[1]. Median PFS (months) in Lutathera arm vs 60 mg octreotide LAR alone was 28.35 vs 11.04 in low (HR=0.218, 95% CI 0.120 to 0.394); Not Reached (NR) vs 8.67 in moderate (HR=0.202, 95% CI 0.077 to 0.525); 19.38 vs 5.52 in high LTB (HR= 0.193, 95% CI 0.079 to 0.474), respectively[1].

Because the numbers of patients and events of deteriorations are small for the moderate and high liver burden groups for quality of life assessments, moderate/high liver burden groups were pooled into one group[1]. Median TTD (months) for global health status (self-assessment of overall health and quality of life) in Lutathera arm vs 60 mg octreotide LAR alone was 28.81 vs 6.11 in low (HR=0.376, 95% CI 0.196 to 0.720); and NR vs 5.98 in moderate/high LTB (HR=0.453, 95% CI 0.178 to 1.152) [1]. Median TTD (months) for physical functioning was 25.20 vs 11.47 in low (HR=0.512, 95% CI 0.264 to 0.994); and NR vs 11.56 in moderate/high LTB (HR=0.526, 95% CI 0.207 to 1.335) [1].

"These results from the NETTER-1 study continue to show that Lutathera delivers strong efficacy in patients with a challenging disease burden," said Samit Hirawat, MD, Head of Novartis Oncology Global Drug Development. "Demonstrating improved PFS and maintenance of QoL in patients with neuroendocrine tumors with poor prognosis due to a high liver tumor burden is a great example of our commitment to reimagining cancer."

Additional sub-analysis evaluated median PFS in patient subgroups with normal or elevated baseline levels of liver enzyme alkaline phosphatase (ALP), and in subgroups with presence or absence of a large (>30 mm diameter) lesion at baseline[1]. Median PFS (months) in Lutathera arm vs 60 mg octreotide LAR alone for the group with normal ALP was 28.35 vs 8.74 (HR=0.204, 95% CI 0.117 to 0.357)[1]. Median PFS (months) in Lutathera arm vs 60 mg octreotide LAR alone for the group with elevated ALP was NR vs 5.78 (HR=0.191, 95% CI 0.090 to 0.405)[1]. Median PFS (months) in Lutathera arm vs 60 mg octreotide LAR alone for the group with a large tumor lesion was 28.35 vs 8.44 (HR=0.266, 95% CI 0.165 to 0.429)[1]. Median PFS (months) in Lutathera arm vs 60 mg octreotide LAR alone for the group without a large tumor lesion was NR vs 8.74 (HR= 0.069, 95% CI 0.021 to 0.233)[1].

The NETTER-1 trial is an international phase III study in patients with progressive, somatostatin receptor-positive midgut neuroendocrine tumors[4]. Patients were randomized to treatment with Lutathera (Lu)(n=117) and best supportive care (30 mg octreotide LAR), or 60 mg octreotide LAR alone (Oct) (n=114). In total, 141 patients had low (71 Lu, 70 Oct), 50 patients had moderate (19 Lu, 31 Oct), and 40 patients had high LTB (27 Lu, 13 Oct).

European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires, a commonly used metric for analysis of HRQoL in cancer patients, were assessed during the trial to determine the impact of treatment on HRQoL[5]. Patients completed the questionnaires at baseline and every 12 weeks until tumor progression. TTD was defined as the time from randomization to the first QoL deterioration >=10 points (on a 100-point scale) compared to baseline score for the same domain.

About Lutathera
Lutathera (lutetium Lu 177 dotatate*) is a lutetium Lu 177-labeled somatostatin analog peptide. Lutathera belongs to a class of treatments called Peptide Receptor Radionuclide Therapy (PRRT). Lutathera is comprised of a targeting molecule which carries a radioactive component. Lutathera has received orphan drug designation from the FDA and the European Medicines Agency (EMA). In the US, Lutathera is indicated for the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults[6]. In Europe, Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults[7]. Lutathera can cause serious side effects that may include bone marrow problems, kidney problems, liver problems, hormonal gland problems, fertility problems and problems arising from radiation exposure. Please see Important Safety Information and Full Prescribing Information at: www.lutathera.com.

* USAN: lutetium Lu 177 dotatate / INN: lutetium (177Lu) oxodotreotide