On June 4, 2019 Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on advancing targeted therapeutics for the treatment of patients with significant unmet needs in hematology and oncology, reported that it has obtained regulatory clarity with the U.S. Food and Drug Administration (FDA) concerning the design of a Phase 3 clinical trial for momelotinib intended to support potential registration of this differentiated drug candidate for the treatment of previously JAK inhibitor treated myelofibrosis patients (Press release, Sierra Oncology, JUN 4, 2019, View Source [SID1234536864]). Following receipt of this clarity, Sierra also announced the design of the MOMENTUM Phase 3 clinical trial in myelofibrosis, planned for launch in Q4 2019.

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"We have held productive discussions with regulators in the US and EU, presenting a holistic analysis of momelotinib’s compelling array of positive efficacy and safety data observed in the two previously completed SIMPLIFY Phase 3 clinical studies, along with our strategy to conduct an additional Phase 3 trial intended to support momelotinib’s potential registration," said Dr. Nick Glover, President and CEO of Sierra Oncology. "We have been exceedingly pleased with the collaborative nature of these discussions which have culminated in alignment on the path to potential registration for momelotinib. Moreover, we have received constructive input that ensures that the design of the MOMENTUM Phase 3 study has the potential to generate compelling and persuasive clinical data capable of satisfying regulatory requirements."

"Momelotinib has consistently demonstrated clinically relevant benefits on the three hallmarks of myelofibrosis: symptoms, anemia and spleen enlargement," noted Dr. Srdan Verstovsek, MD, PhD, Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, Houston, Texas. "I have been involved in the development of momelotinib for many years, and I am very pleased to be named Chief Investigator of the MOMENTUM Phase 3 study. In my opinion, a good proportion of myelofibrosis patients in the second line setting would be candidates for momelotinib treatment due to its potential ability to improve both quality of life and anemia in a significant number of patients. As a myelofibrosis clinician, I can attest that we desperately need more treatment options that offer an array of distinct benefits for our patients. I look forward to momelotinib potentially becoming an important addition to the armamentarium in the treatment of myelofibrosis."

"We have designed MOMENTUM in order to generate highly persuasive clinical data with the potential to convincingly demonstrate momelotinib’s meaningful benefits on symptoms, anemia and spleen in the population of patients previously treated with a JAK inhibitor, as supplemented by both top-line and post hoc analyses of the prior SIMPLIFY Phase 3 datasets," said Dr. Barbara Klencke, Chief Development Officer, of Sierra Oncology. "We have outlined a robust, tractable study that we plan to launch in Q4 2019 and that we anticipate will yield top-line clinical data in Q4 2021."

About MOMENTUM Phase 3 Clinical Trial:
A Randomized, Double-Blind, Phase 3 Study to Evaluate the Activity of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic, Anemic Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera (PV) Myelofibrosis, or Post Essential Thrombocythemia (ET) Myelofibrosis who were Previously Treated with JAK Inhibitor Therapy.

Sierra plans to launch the MOMENTUM Phase 3 clinical trial in Q4 2019. The randomized double-blind trial is designed to enroll 180 myelofibrosis patients who are symptomatic and anemic and have been treated previously with a JAK inhibitor. Patients will be randomized 2:1 to receive either momelotinib or danazol. Danazol has been selected as an appropriate treatment comparator given its use to ameliorate anemia in myelofibrosis patients, as recommended by NCCN and ESMO (Free ESMO Whitepaper) guidelines. After 24 weeks of treatment, patients on danazol will be allowed to crossover to receive momelotinib.

The Primary Endpoint of the trial is the Total Symptom Score (TSS) response rate of momelotinib compared to danazol at Week 24 (99% power; p-value < 0.05). Secondary and exploratory endpoints include:

Transfusion Independence (TI) rate at Week 24 (key secondary: > 90% powered; p-value < 0.05),
Splenic response rate (SRR) at Week 24 (> 90% powered; p-value < 0.05),
Duration of TSS response to Week 48,
Other measures of anemia benefit, including Transfusion Dependence response rate and various measures of cumulative transfusion burden,
Patient Reported Outcome measures of fatigue and physical function.
About Dr. Srdan Verstovsek, Chief Investigator of the MOMENTUM Phase 3 trial:
Dr. Srdan Verstovsek is Chief, Section for Myeloproliferative Neoplasms, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston. Dr. Verstovsek is a world-renowned physician-scientist, and a leading global authority on the treatment of myelofibrosis. His clinical and translational research is focused on understanding the biology of and developing new therapies for myeloproliferative neoplasms (MPNs). He has been Principal investigator for more than 50 clinical trials testing novel therapies for patients with MPNs, and has published more than 400 peer-reviewed manuscripts. He is the recipient of numerous awards including the Celgene 2010 Young Investigator Award, 7th Annual Irwin H. Krakoff Award for Excellence in Clinical and the Distinguished Lecturer Award from the Society of Hematologic Oncology and the Otis W. and Pearl L. Walters Faculty Achievement Award in Clinical Research by MD Anderson Cancer Center. He was made a Member of The American Society for Clinical Investigation in recognition of his contributions as a physician-scientist.

Momelotinib Analyst & Investor Conference Call
The company will be hosting an Analyst and Investor conference call at 6:00am ET on Wednesday, June 5, 2019, to discuss next steps for momelotinib.

Domestic (Toll Free- US): 1-800-239-9838
International (Toll): 1-323-794-2551
Conference ID: 8101895
Webcast Link: www.sierraoncology.com
Direct Link: View Source

Event registration and webcast information are available through the Sierra Oncology website at www.sierraoncology.com. An archive of the presentation will be accessible after the event through the Sierra Oncology website.

About Momelotinib
Momelotinib, Sierra’s lead drug candidate, is a potent, selective and orally-bioavailable JAK1, JAK2 & ACVR1 inhibitor with a differentiated therapeutic profile in myelofibrosis encompassing robust constitutional symptom improvements, a range of meaningful anemia benefits, including eliminating or reducing the need for frequent blood transfusions, and comparable spleen control to ruxolitinib. More than 1,200 subjects have received momelotinib since clinical studies began in 2009, including more than 800 subjects treated for myelofibrosis. Momelotinib is covered by patents anticipated to provide potential exclusivity to 2040 in the U.S.

On June 4, 2019 Array BioPharma Inc. (Nasdaq: ARRY) reported that its Chief Operating Officer, Andrew Robbins, will speak at the Goldman Sachs 40th Annual Global Healthcare Conference in Rancho Palos Verdes, California (Press release, Array BioPharma, JUN 4, 2019, View Source [SID1234536863]). The public is welcome to participate in the conference through a webcast on the Array BioPharma website.

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Event:

Goldman Sachs 40th Annual Global Healthcare Conference

Presenter:

Andrew Robbins, Chief Operating Officer, Array BioPharma

Date:

June 11, 2019

Time:

3:20 p.m. Pacific Time / 6:20 p.m. Eastern Time

Webcast:

https://cc.talkpoint.com/gold006/061119a_as/?entity=45_2CLGG3P

On June 4, 2019 NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported it has appointed Edwina Baskin-Bey, M.D. as its new CMO (Press release, Nanobiotix, JUN 4, 2019, View Source [SID1234536862]).

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Dr. Baskin-Bey brings over 18 years of oncology clinical development and basic science experience in academia and industry, most recently serving as CMO of North Carolina-based oncology start-up, Innocrin Pharmaceuticals. As a member of the Executive Team at Innocrin, Dr. Baskin-Bey led development and implementation of the overall clinical and corporate strategy from phase I to phase III. She was responsible for the Medical, Regulatory, Pharmacovigilance, Clinical Operations, Biostatistics, and Data Management functions.

Dr. Baskin-Bey joined Innocrin from Janssen Oncology of Johnson & Johnson, where she was charged with leading both early-and late-stage oncology global development programs for in-licensed products from Aragon and Tesaro, apalutamide and niraparib. Previously, she worked for more than six years at Astellas Pharma. At Astellas, BV, Netherlands Headquarters, Dr. Baskin-Bey, was responsible for several early-stage oncology programs, most notably, she co-led with the alliance partner, Medivation, the global development strategy for the in-licensed product enzalutamide, leading to FDA approval, EMA approval, and label expansions. Also while at Astellas, she served at the UK Headquarters as head of European Medical Affairs, where she was responsible for the launch of enzalutamide in Europe.

Dr. Baskin-Bey currently serves as an independent board member for Catalyst Clinical Research, LLC, in North Carolina. Dr. Baskin-Bey obtained her bachelor’s degree from Hunter College in New York, and earned her medical degree at Mount Sinai/New York University (NYU) School of Medicine. She trained in general surgery and oncology for seven years at The Mayo Clinic in Rochester, MN, and in basic science research principles at the National Institute of Health (NIH).

Dr. Baskin-Bey succeeds accomplished Nanobiotix CMO, Elsa Borghi, M.D. Dr. Borghi will remain with the company in a key leadership role focused on early development and innovation

On JUne 4, 2019 Novartis reported results from the landmark COMBI-d and COMBI-v clinical trials, concluding that first-line treatment with Tafinlar (dabrafenib) and Mekinist (trametinib) offers both overall and progression-free long-term survival benefits to patients with unresectable or metastatic BRAF-mutation positive melanoma (Press release, Novartis, JUN 4, 2019, View Source [SID1234536861]). Researchers reported that 34% (95% CI: 30-38%) of all patients in the pooled analysis who were treated with Tafinlar + Mekinist survived at five years[1]. Study authors also reported on prolongation in progression-free survival (PFS), with 19% (95% CI: 15-22%) of patients showing no sign of disease progression or death at five years. Five-year overall survival and PFS were similar in the pooled patient population[1],[4].

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The results, from a pooled analysis of 563 patients from the COMBI-d and COMBI-v trials, represented the largest collection of data and longest follow-up among patients with advanced melanoma with BRAF V600-mutated unresectable or metastatic melanoma who were treated with Tafinlar + Mekinist. These data were presented at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting (Abstract #9507) and published simultaneously in The New England Journal of Medicine[1],[4].

"Our analysis demonstrates that first-line therapy with Tafinlar + Mekinist leads to five-year disease control in about one-fifth of the patients and five-year survival in about one-third of those treated," said Caroline Robert, MD, Ph.D., Head of the Dermatology Unit at the Institut Gustave Roussy in Paris. "While metastatic melanoma has historically had a very poor prognosis for patients, there are many reasons to be encouraged today. Our analysis demonstrates a clinically meaningful and positive impact on patient survival. These results show that targeted therapies may provide long-term survival and offer durable outcomes."

Of patients who achieved a complete response with Tafinlar + Mekinist, 19% (n=109) had five-year PFS and overall survival rates of 49% and 71%, respectively, compared with 19% and 34% in the overall population. Researchers also observed that the efficacy of subsequent treatment was preserved in patients who progressed on study treatment and subsequently received immune checkpoint inhibitor therapy.

Adverse events (regardless of causality) were reported in 548 of 559 patients (98%) with no new safety signals. Adverse events (AEs) led to permanent discontinuation of study treatment in 99 of 559 patients (18%); the most common events were pyrexia (4%), decreased ejection fraction (4%) and increased alanine aminotransferase (1%). No treatment-related deaths were reported in patients treated with dabrafenib plus trametinib.

"The five-year COMBI-d/v analysis is truly gratifying, as it shows us that many BRAF+ melanoma patients on Tafinlar + Mekinist are living much longer than what may have been expected when originally diagnosed," said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis. "Other Novartis-sponsored melanoma research at ASCO (Free ASCO Whitepaper) this week illustrates our drive to do even more in melanoma. Efficacy results from the study of the immunotherapy spartalizumab were encouraging as the oncology community learns more about how immunotherapies may be combined with established targeted therapies to provide an even greater benefit to patients."

About COMBI-d and COMBI-v
COMBI-d is a pivotal Phase III randomized, double-blinded study (NCT01584648) comparing the combination of the BRAF inhibitor, Tafinlar, and the MEK inhibitor, Mekinist, to single-agent therapy with Tafinlar and placebo as first-line therapy in patients with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma. The study randomized 422 patients from 121 investigative sites.

COMBI-v is a two-arm, open-label, Phase III study comparing the combination of Tafinlar + Mekinist with vemurafenib monotherapy in patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma (NCT01597908). The primary endpoint of this study was OS[1].

Efficacy Findings for Investigational Anti-PD-1 Antibody Spartalizumab (PDR001) Used in Combination With Tafinlar + Mekinist Also Reported
Also presented at ASCO (Free ASCO Whitepaper) were findings from the COMBI-i study evaluating Tafinlar + Mekinist in combination with spartalizumab in metastatic melanoma patients with known BRAF mutation (Abstract #9531). Results from the 36 patients enrolled in the safety run-in cohort (part 1) and biomarker cohort (part 2) showed a confirmed objective response rate by investigator assessment of 78% (n=28), with 42% (n=15) of patients exhibiting complete responses. All patients experienced at least one AE, 28 had grade >= 3 AEs and six had AEs leading to discontinuation of all three study drugs. The most common AEs (>/= 20%) included pyrexia, cough, arthralgia, rash, chills and fatigue. One patient died of cardiac arrest that was not considered related to study treatment. The clinical trial is ongoing[5].

About the COMBI-i Study
COMBI-i is a pivotal Phase III, double-blinded global study (NCT02967692) comparing the combination of Tafinlar + Mekinist to the same combination along with the investigational anti-PD1 therapy spartalizumab as first-line therapy in patients with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma. The study is being conducted in three parts. In the safety run-in (part 1), the primary endpoint was incidence of dose-limiting toxicities, and in the biomarker cohort (part 2), the primary endpoint was immune microenvironment and biomarker modulation. The randomized portion of the study (part 3) is ongoing, and the primary endpoint is investigator-assessed progression-free survival[5].

About Melanoma
There are about 280,000 new diagnoses of melanoma (Stages 0-IV) worldwide each year[6], approximately half of which have BRAF mutations[7]. Biomarker tests can determine whether a tumor has a BRAF mutation[8].

One way melanoma is staged is by how far it has metastasized. In Stage III melanoma, tumors have spread to the regional lymph nodes, presenting a higher risk of recurrence or metastases[9]. Patients who receive surgical treatment for Stage III melanoma may have a high risk of recurrence because melanoma cells can remain in the body after surgery[10],[11]. Patients should ask their doctor if they are at risk for melanoma returning.

About Tafinlar + Mekinist Combination
Combination use of Tafinlar + Mekinist in patients with stage III resectable, unresectable or metastatic melanoma who have a BRAF V600 mutation is approved in the US, EU, Japan, Australia, Canada and other countries.

The combination of Tafinlar + Mekinist is also approved for the treatment of metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation in the US and advanced NSCLC with a BRAF V600 mutation in the EU.

Tafinlar and Mekinist target different kinases within the serine/threonine kinase family – BRAF and MEK1/2, respectively – in the RAS/RAF/MEK/ERK pathway, which is implicated in NSCLC and melanoma, among other cancers. When Tafinlar is used with Mekinist, the combination has been shown to slow tumor growth more than either drug alone. The combination of Tafinlar + Mekinist is currently being investigated in an ongoing clinical trial program across a range of tumor types conducted in study centers worldwide.

The safety and efficacy profile of the Tafinlar + Mekinist combination has not yet been established outside of the approved indications.

Tafinlar and Mekinist are also indicated in more than 60 countries worldwide, including the US and EU, as single agents to treat patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

Tafinlar + Mekinist Combination Important Safety Information
Tafinlar and Mekinist, in combination, may cause serious side effects such as the risk of new cancers, including both skin cancer and nonskin cancer. Patients should be advised to contact their health care provider immediately for a new wart, skin sore, or bump that bleeds or does not heal, or a change in the size or color of a mole.

When Tafinlar is used in combination with Mekinist, it can cause serious bleeding problems, especially in the brain or stomach, that can lead to death. Patients should be advised to call their health care provider and get medical help right away if they have any signs of bleeding, including headaches, dizziness, or feel weak, cough up blood or blood clots, vomit blood or their vomit looks like "coffee grounds," or red or black stools that look like tar.

Mekinist, alone or in combination with Tafinlar, can cause inflammation of the intestines or tears in the stomach or intestines that can lead to death. Patients should report to their health care provider immediately if they have any of the following symptoms: bleeding, diarrhea (loose stools) or more bowel movements than usual, stomach-area (abdomen) pain or tenderness, fever, or nausea.

Tafinlar, in combination with Mekinist, can cause blood clots in the arms or legs, which can travel to the lungs and can lead to death. Patients should be advised to get medical help right away if they have the following symptoms: chest pain, sudden shortness of breath or trouble breathing, pain in their legs with or without swelling, swelling in their arms or legs, or a cool or pale arm or leg.

The combination of Tafinlar and Mekinist can cause heart problems, including heart failure. A patient’s heart function should be checked before and during treatment. Patients should be advised to call their health care provider right away if they have any of the following signs and symptoms of a heart problem: feeling like their heart is pounding or racing, shortness of breath, swelling of their ankles and feet, or feeling lightheaded.

Tafinlar, in combination with Mekinist, can cause severe eye problems that can lead to blindness. Patients should be advised to call their health care provider right away if they get: blurred vision, loss of vision, or other vision changes, seeing color dots, halo (seeing blurred outline around objects), eye pain, swelling, or redness.

Tafinlar, in combination with Mekinist, can cause lung or breathing problems. Patients should be advised to tell their health care provider if they have new or worsening symptoms of lung or breathing problems, including shortness of breath or cough.

Fever is common during treatment with Tafinlar in combination with Mekinist, but may also be serious. In some cases, chills or shaking chills, too much fluid loss (dehydration), low blood pressure, dizziness, or kidney problems may happen with the fever. Patients should be advised to call their health care provider right away if they get a fever.

Rash and other skin reactions are common side effects of Tafinlar in combination with Mekinist. In some cases these rashes and other skin reactions can be severe or serious, and may need to be treated in a hospital. Patients should be advised to call their health care provider if they get any of the following symptoms: skin rash that bothers them or does not go away, acne, redness, swelling, peeling, or tenderness of hands or feet, or skin redness.

Some people may develop high blood sugar or worsening diabetes during treatment with Tafinlar in combination with Mekinist. For patients who are diabetic, their health care provider should check their blood sugar levels closely during treatment. Their diabetes medicine may need to be changed. Patients should be advised to tell their health care provider if they have increased thirst, urinate more often than normal, or produce an increased amount of urine.

Tafinlar, in combination with Mekinist, may cause healthy red blood cells to break down too early in people with glucose-6-phosphate dehydrogenase deficiency. This may lead to a type of anemia called hemolytic anemia, where the body does not have enough healthy red blood cells. Patients should be advised to tell their health care provider if they have yellow skin (jaundice), weakness or dizziness, or shortness of breath.

Tafinlar, in combination with Mekinist, can cause new or worsening high blood pressure (hypertension). A patient’s blood pressure should be checked during treatment. Patients should be advised to tell their health care provider if they develop high blood pressure, their blood pressure worsens, or if they have severe headache, lightheadedness, blurry vision, or dizziness.

The most common side effects of Tafinlar, in combination with Mekinist, include fever, rash, nausea, fatigue, headache, chills, diarrhea, vomiting, high blood pressure (hypertension), joint aches, muscle aches, swelling of the face, arms, or legs, and cough.

Please see full Prescribing Information for Tafinlar and

On JUne 4, 2019 Epigenomics AG (FSE: ECX, OTCQX: EPGNY; the "Company") reported that company management will be presenting at the Raymond James Life Sciences and MedTech Conference in New York on Tuesday, June 18, 2019, at 1:50 pm (EDT) / 7:50 pm (CET) and invites investors to participate by webcast (Press release, Epigenomics, JUN 4, 2019, View Source [SID1234536860]). The webcast can be accessed via the following link View Source as well as in the investor relations section of Epigenomics’ website at www.epigenomics.com.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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