On February 5, 2019 Sanofi reported that the pivotal Phase 3 trial of isatuximab in patients with relapsed/refractory multiple myeloma met the primary endpoint of prolonging progression free survival in patients treated with isatuximab in combination with pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone alone (standard of care) (Press release, Sanofi, FEB 5, 2019, View Source [SID1234533065]).

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Results will be submitted to an upcoming medical meeting and are anticipated to form the basis of regulatory submissions planned for later this year.

"We are excited by these results, which represent significant progress in our ambition to extend the lives of multiple myeloma patients," said John Reed, Head of Research and Development at Sanofi. "We look forward to engaging with regulatory authorities with the goal of bringing this potential new treatment to patients as quickly as possible."

Multiple myeloma is the second most common hematologic malignancy[1], with more than 138,0002 new cases worldwide each year. Multiple myeloma remains incurable in the vast majority of patients, resulting in significant disease burden.

The randomized, multi-center, open label Phase 3 study, known as ICARIA-MM, enrolled 307 patients with relapsed/refractory multiple myeloma across 96 centers spanning 24 countries. All study participants received two or more prior anti-myeloma therapies, including at least two consecutive cycles of lenalidomide and a proteasome inhibitor given alone or in combination. During the trial, isatuximab was administered through an intravenous infusion at a dose of 10mg/kg once weekly for four weeks, then every other week for 28-day cycles in combination with standard doses of pomalidomide and dexamethasone for the duration of treatment. The safety profile was evaluated as a secondary endpoint.

About isatuximab clinical development program

Isatuximab targets a specific epitope of CD38 capable of triggering multiple, distinct mechanisms of action that are believed to promote programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on multiple myeloma cells and is a cell surface receptor target for antibody-based therapeutics in multiple myeloma and other malignancies. The clinical significance of these findings is under investigation.

ICARIA-MM is one of four ongoing Phase 3 clinical trials evaluating isatuximab in combination with currently available standard treatments for people with relapsed/refractory or newly-diagnosed multiple myeloma.

Isatuximab received orphan designation for relapsed/refractory multiple myeloma by the U.S. Food and Drug Administration and the European Medicines Agency. Isatuximab is an investigational agent and the safety and efficacy has not been evaluated by the U.S. Food and Drug Administration, the European Medicines Agency, or any other regulatory authority. Isatuximab is also under investigation for the treatment of other hematologic malignancies and solid tumors.

On February 5, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported completing the submission of a supplemental Biologics License Application to the US Food and Drug Administration (FDA) for Kadcyla (trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast cancer (eBC) with residual disease after neoadjuvant (before surgery) treatment (Press release, Hoffmann-La Roche, FEB 5, 2019, View Source [SID1234533047]). The FDA is reviewing the application under the Real-Time Oncology Review and Assessment Aid pilot programmes, which aim to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.[1,2] For this indication, Kadcyla was also granted Breakthrough Therapy Designation, which is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases.[3]

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"Kadcyla was granted Breakthrough Therapy Designation and is also the first Roche medicine to be reviewed under the FDA’s Real-Time Oncology Review pilot programme; both FDA initiatives aim to expedite reviews and bring medicines to patients sooner" said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "We are working closely with the FDA to bring Kadcyla to people with HER2-positive early breast cancer who have residual disease after neoadjuvant therapy as early as possible."

This application is based on results of the phase III KATHERINE study showing Kadcyla significantly reduced the risk of invasive breast cancer recurrence or death from any cause (invasive disease-free survival; iDFS) by 50% (HR=0.50, 95% CI 0.39-0.64, p<0.0001) compared to Herceptin (trastuzumab) as an adjuvant treatment in people with HER2-positive eBC who have residual disease present following neoadjuvant treatment.[4] People who have residual disease after neoadjuvant treatment have a worse prognosis than those with no detectable disease. At three years, 88.3% of people treated with Kadcyla did not have their breast cancer return compared to 77.0% treated with Herceptin, an absolute improvement of 11.3%.[4]

The most common Grade 3-4 side effects (>1%) with Kadcyla in the KATHERINE study were decreased platelet count; high blood pressure; radiation-induced skin injury; numbness, tingling or pain in the hands or feet; decreased neutrophil count; low blood potassium level; fatigue and decrease in red blood cells.[4]

About the KATHERINE study[5]
KATHERINE is an international, multi-centre, two-arm, randomised, open-label, phase III study evaluating the efficacy and safety of Kadcyla versus Herceptin as an adjuvant therapy in people with HER2-positive eBC who have pathological invasive residual disease in the breast and/or axillary lymph nodes following neoadjuvant therapy that included Herceptin and taxane-based chemotherapy. The primary endpoint of the study is iDFS, which in this study is defined as the time from randomisation free from invasive breast cancer recurrence or death from any cause. Secondary endpoints include disease-free survival and overall survival.

About Kadcyla
Kadcyla is an antibody-drug conjugate (ADC) engineered to deliver potent chemotherapy directly to HER2-positive cancer cells, potentially limiting damage to healthy tissues.[6,7] It combines two anti-cancer properties joined together by a stable linker: the HER2-targeting properties of trastuzumab (the active ingredient in Herceptin) and the chemotherapy agent DM1.[8] Kadcyla is the only ADC approved as a single agent in 104 countries including the US and EU for the treatment of people with HER2-positive metastatic breast cancer who have previously received Herceptin and taxane chemotherapy, separately or in combination. Roche licenses technology for Kadcyla under an agreement with ImmunoGen, Inc.

About Roche’s medicines for HER2-positive breast cancer
Roche has been leading research into the HER2 pathway for over 30 years and is committed to improving the health, quality of life and survival of people with both early and advanced HER2-positive disease. HER2-positive breast cancer is a particularly aggressive form of the disease that affects approximately 15-20% of patients.[9] Roche has developed three innovative medicines that have helped transform the treatment of HER2-positive breast cancer: Herceptin (trastuzumab), Perjeta (pertuzumab) and Kadcyla (trastuzumab emtansine). Eligibility for treatment with Roche’s HER2-targeted medicines is determined via a diagnostic test, which identifies people who will likely benefit from these medicines at the onset of their disease.

On February 5, 2019 Taiho Pharmaceutical Co., Ltd. and Cullinan Oncology, LLC reported on February 5 an agreement to develop TAS6417, a novel EGFR (epidermal growth factor receptor) tyrosine kinase inhibitor discovered by Taiho Pharmaceutical (Press release, Taiho, FEB 5, 2019, View Source [SID1234533083]).

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Under the terms of the agreement, Taiho Pharmaceutical will grant an exclusive, global license ex-Japan for the development and commercialization of TAS6417 to Cullinan Pearl, a newly formed USbased company under the Cullinan Oncology umbrella. Taiho Pharmaceutical will receive an upfront payment, regulatory and sales milestones, as well as royalties based on net sales. Taiho Ventures, LLC, a strategic corporate venture arm of Taiho Pharmaceutical, alongside Cullinan Oncology, will provide funding for Cullinan Pearl’s Series A.

"The Taiho’s drug research team created a unique molecule targeting EGFR Exon 20 insertion mutation using proprietary drug discovery platform technology. This alliance, one of the first of its kind at Taiho Pharmaceutical, allows our organization to optimize its R&D resource allocation and accelerate global development by accessing external talent and resources. We are pleased to partner with Cullinan Oncology and its experienced management team in bringing this novel treatment to NSCLC patients," said Teruhiro Utsugi, Managing Director of Taiho Pharmaceutical.

Cullinan Pearl will utilize Cullinan Oncology’s shared service platform to develop TAS6417, which relies on a central management team and a network of integrated collaborators to help drive the development of preclinical and clinical assets.

"We are excited to partner with Taiho Pharmaceutical and Taiho Ventures in exploring the utility of this novel drug in a patient population with limited options to date. We are thankful for Taiho’s trust in our team’s ability to execute the clinical development of this exciting asset," stated Owen Hughes, CEO of Cullinan Oncology.

About TAS6417

TAS6417 is an orally available tyrosine kinase inhibitor designed to target activating mutations in EGFR. The molecule was engineered to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR. TAS6417 is a clinical candidate for NSCLC driven by EGFR exon 20 insertion mutations and is expected to be a novel therapeutic option for the patients with highly unmet medical needs

On February 5, 2019 Myriad Genetics, Inc. (NASDAQ: MYGN, "Myriad" or the "Company"), a global leader in molecular diagnostics and personalized medicine, reported financial results for its fiscal second-quarter 2019, provided an update on recent business highlights, maintained its fiscal year 2019 financial guidance and provided fiscal third-quarter 2019 financial guidance (Press release, Myriad Genetics, FEB 5, 2019, View Source [SID1234533067]).

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"This quarter we saw a return to revenue growth for our hereditary cancer business, an acceleration in our prenatal testing and continued profitability improvements driven by the Elevate 2020 program," said Mark C. Capone, president and CEO, Myriad Genetics. "Importantly, in the last month, we announced two pivotal events with the publication of the GeneSight GUIDED study and the launch of our expanded Women’s Health sales team, which have the potential to drive transformational growth and long-term shareholder value."

Business Highlights

Hereditary Cancer

Revenue returned to growth for the first time since fiscal year 2014.

Achieved eighth consecutive quarter of year-over-year hereditary cancer testing volume growth and fifth consecutive quarter with stable hereditary cancer pricing.

Presented validation study on riskScore for women of Hispanic descent at the 2018 San Antonio Breast Cancer Symposium, consisting of almost 9,000 women analyzed with a proprietary test that was highly predictive of breast cancer risk (p= 7.1 x 10-19).

Submitted our application to the Japanese Ministry of Health, Labour, and Welfare, for BRACAnalysis in hereditary cancer patients. There are approximately 3 million women in Japan who will be candidates for this test if approved.

GeneSight

GeneSight test volume increased 22 percent year over year.

GeneSight revenue was negatively impacted by changes in Medicare documentation requirements and the impact on cash collections from recently implemented industry-wide laboratory benefit manager programs.

A record 16,000 physicians ordered a GeneSight test in the fiscal second quarter.

Published the landmark GUIDED study in the Journal of Psychiatric Research, which is the largest prospective pharmacogenomics study ever conducted in depression. The key finding of the study was that patients were 50 percent more likely to achieve remission and 30 percent more likely to respond to treatment when their medication selection was guided by the GeneSight test.

Prenatal Testing

Prenatal testing volume increased at a double-digit rate year-over-year with total revenue increasing 12 percent sequentially.

Completed sales force expansion in early January, tripling the number of sales representatives selling prenatal tests.

Launched Myriad Complete application which includes patient education, cost estimators, test results, electronic reporting, and counseling tools for physician and patient customers, covering all Myriad Women’s Health products including myRisk Hereditary Cancer.

Published a large clinical utility study for ForeSight in Genetics in Medicine. The study found that the ForeSight test led to significant changes in pregnancy management with 77 percent of at-risk couples taking steps to avoid having an affected offspring such as prenatal

diagnostic testing and in-vitro fertilization.

Vectra

Fiscal second-quarter revenue increased six percent year over year to $11.8 million.

Published study in Rheumatology demonstrating that Vectra was five times more predictive of radiographic progression compared to historical measures of disease activity.

Prolaris

Fiscal second-quarter revenue increased 45 percent year-over-year to $6.1 million.

EndoPredict

Fiscal second-quarter revenue increased 10 percent year-over-year to $2.2 million.

Received favorable National Comprehensive Cancer Network Guidelines.

Received a favorable recommendation from NICE in the United Kingdom providing reimbursement coverage for the test.

Presented data at the San Antonio Breast Cancer Symposium (SABCS) from a retrospective study with 3,746 women that evaluated the benefit of chemotherapy on 10-year distant recurrence in women with estrogen receptor positive, HER2 negative breast cancer. The study found that women with a high EndoPredict score who received chemotherapy saw a statistically significant benefit with lower rates of 10-year distant recurrence compared to high risk women who did not receive chemotherapy.

A second study presented at SABCS evaluated the distant recurrence rates in 1,702 women who received five years of endocrine therapy alone and were followed for 15 years. This study showed a four-fold risk of recurrence in the 5 to 15 year timeframe for women with a high EndoPredict score and demonstrates EndoPredict can identify women who will benefit from extended endocrine therapy.

A third, 373 patient study was presented at SABCS that is positioned to corroborate the ability of EndoPredict to predict chemotherapy benefit. This is the first prospective study to ever evaluate chemoprediction in a high-risk cohort for any breast cancer recurrence test. In a 3-year interim evaluation of the data, high-risk patients who received chemotherapy had a disease free recurrence rate of 96.3 percent compared to 91.5 percent in the high-risk patients who did not receive chemotherapy (p=0.06).

Companion Diagnostics

Received U.S. Food and Drug Administration approval for BRACAnalysis CDx for use in conjunction with olaparib for maintenance in first-line ovarian cancer.

Completed our submission in Japan for BRACAnalysis CDx as a companion diagnostic in first line ovarian cancer with olaparib.

Fiscal Year 2019 and Fiscal Third-Quarter 2019 Financial Guidance

Myriad’s fiscal year 2019 and third-quarter 2019 adjusted earnings per share guidance excludes the impact of stock based compensation expense, non-cash amortization associated with acquisitions and certain non-recurring expenses. These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The Company will provide further details on its business outlook during the conference call today and discuss the fiscal second-quarter financial results and fiscal year 2019 financial guidance.

Conference Call and Webcast

A conference call will be held today, Tuesday, February 5, 2019, at 4:30 p.m. EDT to discuss Myriad’s financial results for the fiscal second-quarter, business developments and financial guidance. The dial-in number for domestic callers is 1-888-222-6159. International callers may dial 1-303-223-4369. All callers will be asked to reference reservation number 21914704. An archived replay of the call will be available for seven days by dialing (800) 633-8284 and entering the reservation number above. The conference call along with a slide presentation will also will be available through a live webcast at www.myriad.com.

On February 5, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX & MDAX; NASDAQ: MOR) reported the appointment of David R. Trexler as President and member of the Board of Directors of MorphoSys US Inc., effective February 6, 2019 (Press release, MorphoSys, FEB 5, 2019, View Source [SID1234533085]). Mr. Trexler will lead the ongoing build-up of MorphoSys’s U.S. subsidiary with a focus on establishing the company’s commercial capabilities in preparation for the planned commercialization of MOR208 in the U.S.

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"I am delighted to welcome David Trexler to MorphoSys. With his experience and proven track record in establishing commercial organizations for international pharmaceutical companies as well as successfully executing oncology product launches in the U.S., he is ideally qualified to lead MorphoSys US Inc. We very much look forward to working with him," said Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG and Chairman of the Board of Directors of MorphoSys US Inc. "I would like to thank Jim Hussey for his outstanding contribution as interim president of our U.S. subsidiary over the last five months. Jim will now resume his position as special advisor to me in my role as Chairman of MorphoSys US Inc."

Mr. Trexler has built his career in leadership positions for branded pharmaceuticals in marketing, sales, business development and general management. He joins MorphoSys from EMD Serono, a business of Merck KGaA, Darmstadt, Germany, where he held positions of increasing seniority including most recently positions as Global Brand Lead, Bavencio and Senior Vice President US Oncology Commercial. At EMD Serono, he was responsible for building Merck KGaA’s first commercial oncology footprint in the U.S. and for the successful launch of Bavencio (avelumab) for metastatic Merkel cell carcinoma (mMCC). Prior to EMD Serono, Mr. Trexler worked for 10 years in various marketing roles in oncology for Eisai Inc., in particular as Senior Vice President Americas Oncology, where he was responsible for sales and marketing of Eisai’s oncology portfolio across the U.S. and supported efforts in Canada, Mexico and Brazil. Mr. Trexler previously held leadership roles at Mylan Bertek Pharmaceuticals (2004-2005) and Sanofi-Aventis Pharmaceuticals (1986-2004).

"I am enthused to join MorphoSys US Inc. at this exciting time in the Company’s development," commented David Trexler. "I look forward to working closely with the entire MorphoSys team to build our U.S. organization to enable a successful launch of MOR208 in this country, subject of course to prior FDA approval."