On March 26, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that its licensing partner, Janssen Biotech, Inc., has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (U.S. FDA) for the use of daratumumab (DARZALEX) in combination with bortezomib, thalidomide and dexamethasone (VTD) as treatment for newly diagnosed patients with multiple myeloma who are candidates for autologous stem cell transplant (ASCT) (Press release, Genmab, MAR 26, 2019, View Source [SID1234534637]). In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

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"This application is an important step in potentially providing a new group of multiple myeloma patients access to DARZALEX. We look forward to the U.S. FDA’s feedback regarding this proposed front line indication," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The submission is based on data from the Phase III CASSIOPEIA study of daratumumab in combination with VTD as frontline treatment for patients with multiple myeloma who are candidates for ASCT. The study is sponsored by the French Intergroupe Francophone du Myelome (IFM) in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen R&D, LLC. The topline results of the data were announced in October 2018 and Janssen expects to publish detailed data from the study during 2019.

About the CASSIOPEIA (MMY3006) study
This Phase III study is a randomized, open-label, multicenter study, run by the French Intergroupe Francophone du Myelome (IFM) in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen R&D, LLC, including 1,085 newly diagnosed subjects with previously untreated symptomatic multiple myeloma who are eligible for high dose chemotherapy and stem cell transplant. In the first part of the study, patients were randomized to receive induction and consolidation treatment with daratumumab combined with bortezomib, thalidomide (an immunomodulatory agent) and dexamethasone (a corticosteroid) or bortezomib, thalidomide and dexamethasone alone. The primary endpoint is the proportion of patients that achieve a stringent Complete Response (sCR). In the second part of the study, patients that achieved a response will undergo a second randomization to either receive maintenance treatment of daratumumab 16 mg/kg every 8 weeks for up to 2 years versus no further treatment (observation). The primary endpoint of this part of the study is progression free survival (PFS).

About multiple myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Multiple myeloma is the third most common blood cancer in the U.S., after leukemia and lymphoma.2 Approximately 26,000 new patients were expected to be diagnosed with multiple myeloma and approximately 13,650 people were expected to die from the disease in the U.S. in 2018.3 Globally, it was estimated that 160,000 people were diagnosed and 106,000 died from the disease in 2018.4 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.5

About DARZALEX(daratumumab)
DARZALEX (daratumumab) injection for intravenous infusion is indicated in the United States in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.6 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX is approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for treatment of adults with relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market. For more information, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).6,7,8,9,10

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and frontline multiple myeloma settings and in amyloidosis. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases, such as NKT-cell lymphoma B and T-ALL. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA, for multiple myeloma, as both a monotherapy and in combination with other therapies.

On March 26, 2019 Zenyaku Kogyo Co., Ltd. (Japanese-only website) and Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that Zenyaku obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW), for an anti-CD20 monoclonal antibody, RITUXAN injection 100 mg and 500 mg [generic name: rituximab (genetical recombination)] (hereafter, "RITUXAN"), which was co-developed by the two companies for an additional indication of CD20-positive chronic lymphocytic leukemia (CLL) (Press release, Chugai, MAR 26, 2019, View Source [SID1234534622]). RITUXIAN is co-marketed by the two companies in Japan.

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RITUXAN is an anti-CD20 monoclonal antibody that specifically binds to CD20, a protein expressed on B cells other than stem and plasma cells, which attacks B cells as targets with the immune system in the body. RITUXAN is used in combination with other antineoplastic drugs for the treatment of CD20-positive CLL, the additional indication approved this time.

CLL is a disease in which small mature B lymphocytes proliferate monoclonally and proliferate in peripheral blood, bone marrow, lymph nodes and spleen, many of which progress slowly. This rare disease is mostly prevalent in elderly people, and considered as difficult to cure with current treatments while many patients often experience recurrence and progression repeatedly. The number of patients in Japan is small, reportedly about 0.3 to 100,000 people per year. The age of onset is typically over 50 years, and rarely seen in people under 30 years of age. In patients with CLL, the ratio of males to females is higher at about 1.5 or 2 to 1*.

Zenyaku and Chugai will continue to work closely together to make RITUXAN contribute to the treatment of CD20-positive CLL.

* Center for Cancer Control and Information Services. Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma
View Source (Japanese only)

On March 26, 2019 Prometic Life Sciences Inc. (TSX: PLI, OTCQX: PFSCF) ("Prometic" or the "Corporation") reported that it will report its financial results for the fourth quarter and year ended December 31, 2018 on Monday April 1, 2019 after market close (Press release, ProMetic Life Sciences, MAR 26, 2019, View Source [SID1234534638]).

Prometic will host a conference call at 11:00am (ET) on Tuesday April 2, 2019. The telephone numbers to access the conference call are 1-888-231-8191 and 647-427-7450. An audio replay of the call will be available as of Tuesday April 2, 2019 at 2:00pm (ET). The numbers to access the audio replay are 416-849-0833 and 1-855-859-2056 using the following password (3198209).

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A live audio webcast of the conference call will be available via: View Source About Prometic Life Sciences Inc.

On March 25, 2019 Race Oncology reported that it has announced the US Food and Drug Administration has received its Investigational New Drug (IND) application for the company’s cancer drug Bisantrene (Press release, Race Oncology, MAR 25, 2019, View Source [SID1234534583]).

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The IND application is a major milestone in the approval process for the company’s Acute Myeloid Leukaemia (AML) drug in the United States. The application is a precursor to Race Oncology’s intended 250-patient clinical trial of Bisantrene for the treatment of adult AML.

"The filing of the IND definitely brands Bisantrene as a Phase III asset," said Race Oncology CEO Peter Molloy.

Because Bisantrene is entering the clinical and regulatory process at Phase III, the IND comprises the entire history of Bisantrene’s preclinical and clinical development, along with Phase III quality manufacturing and other data.

"Race Oncology is well advanced in our push to get FDA approval of Bisantrene in the United States. Our team has been focused on this milestone for the past six months," said Race Oncology CEO Peter Molloy.

The FDA will now take 30 days to review the application, which consists of new chemistry and manufacturing data developed by Race Oncology, as well as the entire history of the pre-clinical and clinical development of Bisantrene over three decades.

Bisantrene is a chemotherapy drug that was the subject of more than forty phase two clinical studies during the 1980s and 1990s. Race has rescued the drug after it was lost in a series of big pharma mergers.

In addition to underpinning the adult AML approval of Bisantrene, the IND will be the core regulatory document and springboard for Race’s planned trial in paediatric AML.

Race has received a Rare Paediatric Disease designation for Bisantrene from the FDA, and upon a successful paediatric trial, could receive a valuable and saleable ‘Priority Review Voucher’ (PRV).

The Company is now in advanced discussions around the funding and conduct of the paediatric trial.

"The IND is the culmination of nearly three years of manufacturing and development work at Race Oncology, and it now provides the launch pad for a number of value creating programs," said Mr Molloy.

"I regard this IND as our most important achievement to date," added Mr Molloy.

On March 25, 2019 Genomic Health, Inc. (NASDAQ: GHDX) reported that new data presented at the 16th St.Gallen International Breast Cancer Conference in Vienna reinforce the utility of the Oncotype DX Breast Recurrence Score test to optimize chemotherapy recommendations in patients with early-stage breast cancer with or without lymph node involvement (Press release, Genomic Health, MAR 25, 2019, View Source [SID1234534605]).

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The important role of genomic testing to optimize patient outcomes in early-stage breast cancer was discussed in a debate between leading international breast cancer specialists during the St. Gallen Conference. The experts presented several case studies showing that genomic testing adds value beyond clinical pathological factors, and they agreed that there are substantial differences between the available tests.

"Only a test such as Oncotype DX that has been developed specifically to be predictive of chemotherapy benefit can identify the right treatment for the right patient," said Prof. Joseph Gligorov, M.D., of the Breast Cancer Expert Center at the APHP-Tenon Hospital in Paris, who participated in the panel discussion. "The practice-changing precision made possible by such a test can lead to improved quality of care and survival among breast cancer patients, as well as reduced waste of healthcare resources by directing chemotherapy only to patients who have a high likelihood of deriving substantial benefit."

Oncotype DX Data Presentations
An updated analysis of the Clalit Health Services registry, the largest health services organization in Israel, was presented at the Conference. This analysis examined the medical records of more than 1,300 patients with node-negative breast cancer applying the Recurrence Score cut point determined by the landmark TAILORx study. The findings showed that use of chemotherapy was aligned with Oncotype DX test results and that patients with Recurrence Score results up to 25, the vast majority of whom were treated with hormonal therapy alone, had excellent outcomes at 10 years, with low rates of distant recurrence.

Also presented at the Conference was real-world evidence from a study in more than 80,000 patients, based on an analysis of data from the Surveillance, Epidemiology, and End Results (SEER) registry program of the National Cancer Institute (NCI). The findings confirmed that the Recurrence Score result is predictive of chemotherapy benefit in patients with node-negative disease (p=0.009), with no chemotherapy benefit in patients with Recurrence Score results up to 25. In patients with node-negative disease and Recurrence Score results up to 25 not treated with chemotherapy, the Breast Cancer Specific Survival (BCSS) was greater than 98 percent at nine years. In patients with node-positive disease not treated with chemotherapy and Recurrence Score results less than 18, BCSS was greater than 97 percent at nine years.

Importantly, this real-world evidence reinforces the paradigm established by the TAILORx study, which provided definitive information on how to treat women with node-negative early-stage breast cancer based on their Recurrence Score results. TAILORx, the largest randomized adjuvant breast cancer treatment trial ever conducted, identified the vast majority of women who receive no substantial benefit from chemotherapy, as well as the important minority for whom chemotherapy can be life-saving.

Results of two decision impact studies from the UK and the Czech Republic, highlighting the value of Oncotype DX to personalize and improve the quality of clinical decisions, also were presented at the Conference. In the UK study, clinical practice results from 582 patients with node-positive disease (one to three positive lymph nodes) showed that chemotherapy recommendations changed in a significant proportion of patients following testing with Oncotype DX. In particular, the test allowed more than 60 percent of patients to be spared chemotherapy and its associated short- and long-term side-effects. Conversely, the test identified 23 patients who were initially advised to undergo only endocrine therapy, but whose treatment was changed to add chemotherapy based on their Recurrence Score result. Without testing, these patients would not have received potentially life-saving chemotherapy treatment.

"In serving more than one million cancer patients around the world with Oncotype DX, we are delivering on the promise of precision medicine by improving outcomes, while saving healthcare systems around the world billions of dollars," said Rick Baehner, M.D., chief medical officer, Genomic Health. "These new data, based on results from thousands of patients in the U.S. and Europe, further reinforce the value and need for broader global access to Oncotype DX testing."

About Oncotype DX
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The company’s flagship product, the Oncotype DX Breast Recurrence Score test, is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention, and the Oncotype DX AR-V7 Nucleus Detect test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to androgen receptor (AR)-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Genomic Health. With more than 1 million patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.