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McKesson Announces Preliminary Results of Exchange Offer

On March 10, 2020 McKesson Corporation (NYSE:MCK) reported that its previously announced offer to stockholders to exchange their shares of McKesson common stock on a per-share-basis for 11.4086 shares of PF2 SpinCo, Inc. ("SpinCo") common stock expired at 11:59 p.m., New York City time, on March 9, 2020, and, based on preliminary results, the exchange offer was oversubscribed (Press release, McKesson, MAR 10, 2020, View Source [SID1234555378]). The exchange offer to split-off SpinCo, which holds McKesson’s interest in Change Healthcare LLC ("Change Healthcare"), is part of McKesson’s agreement with Change Healthcare Inc. (NASDAQ:CHNG) ("Change") to merge SpinCo with and into Change (the "Merger").

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According to the exchange agent for the exchange offer, Equiniti Trust Company, 98,165,418 shares of McKesson common stock were tendered prior to the expiration of the exchange offer, including 65,256,714 shares of McKesson common stock validly tendered and 32,908,704 shares of McKesson common stock that were tendered by notice of guaranteed delivery. McKesson has accepted 15,426,537 of the tendered shares of McKesson common stock in exchange for 175,995,192 shares of SpinCo common stock.

Immediately following the consummation of the exchange offer, and by means of the merger of SpinCo with and into Change, each outstanding share of SpinCo common stock will be converted into one share of Change common stock (with cash in lieu of fractional shares).

Because the exchange offer was oversubscribed, McKesson accepted tendered shares of McKesson common stock on a pro rata basis in proportion to the total number of shares tendered and not validly withdrawn. Stockholders who owned fewer than 100 shares of McKesson common stock, or an "odd lot," and who validly tendered all of their shares are not subject to proration in accordance with the terms of the exchange offer.

Based on the total number of shares of McKesson common stock that were reported as tendered prior to the expiration of the exchange offer, it is estimated that approximately 14.70% of the tendered shares of McKesson common stock that are subject to proration will be exchanged for shares of SpinCo common stock, assuming all shares tendered by guaranteed delivery procedures are delivered under the terms of the exchange offer. The preliminary proration factor is subject to change based on the number of tendered shares that satisfy the guaranteed delivery procedures.

McKesson expects to announce the final proration factor as soon as possible following the expiration of the guaranteed delivery period, which will occur on March 11, 2020. Promptly after the final proration factor is announced, shares of McKesson common stock tendered but not accepted for exchange will be returned to the tendering stockholders in book-entry form. Also at that time, the exchange agent for the exchange offer will deliver to Change’s transfer agent a final stockholder list for SpinCo common stock to be received by tendering McKesson stockholders whose shares were accepted for exchange in the exchange offer. Change’s transfer agent will use the final stockholder list to credit such tendering McKesson stockholders with whole shares of Change common stock. Fractional shares of Change common stock deliverable to tendering McKesson common stock holders will be aggregated and sold in the open market by Change’s transfer agent, or otherwise as reasonably directed by McKesson within 20 business days after the effective time of the Merger. Checks in lieu of fractional shares will thereafter be delivered to such tendering McKesson common stock stockholders by Change’s transfer agent, after deducting any required withholding taxes and brokerage charges, commissions and transfer taxes, on a pro rata basis, without interest, as soon as practicable.

In connection with the transactions, Goldman Sachs & Co. LLC is acting as financial advisor and Davis Polk & Wardwell LLP is acting as legal advisor to McKesson.

Takeda Provides Update on TOURMALINE-MM2 Phase 3 Trial

On March 10, 2020 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported the results from the TOURMALINE-MM2 study designed to evaluate the addition of NINLARO (ixazomib) to lenalidomide and dexamethasone in newly diagnosed transplant ineligible multiple myeloma patients (Press release, Takeda, MAR 10, 2020, View Source [SID1234555377]). The addition of ixazomib to lenalidomide and dexamethasone resulted in an improvement in median progression-free survival (PFS) of 13.5 months (35.3 months versus 21.8 months; hazard ratio [HR] 0.83; p=0.073); however, it did not meet the threshold for statistical significance. The safety profile associated with NINLARO from the TOURMALINE-MM2 trial was generally consistent with the existing prescribing information.

Results from the TOURMALINE-MM2 study will be submitted to an upcoming medical congress.

"There is a need for treatment options in transplant ineligible patients. We remain committed to advancing the field of multiple myeloma and continue to drive innovation through ongoing research and development," said Christopher Arendt, Head, Oncology Therapeutic Area Unit, Takeda. "We are confident there will be numerous learnings from this trial and look forward to sharing these data with the community. We want to thank the patients and investigators for their participation in this important program."

Investigators have been informed of the outcome and will discuss the potential impact with study participants. For patients currently enrolled in this study, it is up to the discretion of physicians to continue their current treatment.

About the TOURMALINE-MM2 Trial

TOURMALINE-MM2 is an international, randomized, double-blind, multicenter, placebo-controlled Phase 3 clinical trial, designed to evaluate NINLAROTM (ixazomib) plus lenalidomide and dexamethasone compared to placebo plus lenalidomide and dexamethasone, in 705 adult patients with newly diagnosed multiple myeloma who are not candidates for transplant. The primary endpoint is progression-free survival (PFS). Key secondary endpoints include rate of complete response (CR), pain response and overall survival (OS). For additional information: View Source

About Multiple Myeloma

Multiple myeloma is a life-threatening rare blood cancer that arises from the plasma cells, a type of white blood cell that is made in the bone marrow. These plasma cells become abnormal, multiply and release a type of antibody known as a paraprotein, which causes symptoms of the disease, including bone pain, frequent or recurring infections and fatigue, a symptom of anemia. These malignant plasma cells have the potential to affect many bones in the body and can cause a number of serious health problems affecting the bones, immune system, kidneys and red blood cell count. The typical multiple myeloma disease course includes periods of symptomatic myeloma followed by periods of remission. Nearly 230,000 people around the world live with multiple myeloma, with approximately 114,000 new cases diagnosed globally each year.

About NINLAROTM (ixazomib) capsules

NINLARO (ixazomib) is an oral proteasome inhibitor which is being studied across the continuum of multiple myeloma treatment settings. NINLARO was first approved by the U.S. Food and Drug Administration (FDA) in November 2015 and is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. NINLARO is currently approved in more than 60 countries, including the United States, Japan and in the European Union, with more than 10 regulatory filings currently under review. It was the first oral proteasome inhibitor to enter Phase 3 clinical trials and to receive approval.

NINLAROTM (ixazomib): GLOBAL IMPORTANT SAFETY INFORMATION

SPECIAL WARNINGS AND PRECAUTIONS

Thrombocytopenia has been reported with NINLARO (28% vs. 14% in the NINLARO and placebo regimens, respectively) with platelet nadirs typically occurring between Days 14-21 of each 28-day cycle and recovery to baseline by the start of the next cycle. It did not result in an increase in hemorrhagic events or platelet transfusions. Monitor platelet counts at least monthly during treatment with NINLARO and consider more frequent monitoring during the first three cycles. Manage with dose modifications and platelet transfusions as per standard medical guidelines.

Gastrointestinal toxicities have been reported in the NINLARO and placebo regimens respectively, such as diarrhea (42% vs. 36%), constipation (34% vs. 25%), nausea (26% vs. 21%), and vomiting (22% vs. 11%), occasionally requiring use of antiemetic and anti-diarrheal medications, and supportive care.

Peripheral neuropathy was reported with NINLARO (28% vs. 21% in the NINLARO and placebo regimens, respectively). The most commonly reported reaction was peripheral sensory neuropathy (19% and 14% in the NINLARO and placebo regimens, respectively). Peripheral motor neuropathy was not commonly reported in either regimen (< 1%). Monitor patients for symptoms of peripheral neuropathy and adjust dosing as needed.

Peripheral edema was reported with NINLARO (25% vs. 18% in the NINLARO and placebo regimens, respectively). Evaluate patients for underlying causes and provide supportive care, as necessary. Adjust the dose of dexamethasone per its prescribing information or the dose of NINLARO for severe symptoms

Cutaneous reactions occurred in 19% of patients in the NINLARO regimen compared to 11% of patients in the placebo regimen. The most common type of rash reported in both regimens was maculo-papular and macular rash. Manage rash with supportive care, dose modification or discontinuation.

Thrombotic microangiopathy, sometimes fatal, including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), have been reported in patients who received NINLARO. Monitor for signs and symptoms of TPP/HUS and stop NINLARO if diagnosis is suspected. If the diagnosis of TPP/HUS is excluded, consider restarting NINLARO. The safety of reinitiating NINLARO therapy in patients previously experiencing TPP/HUS is not known.

Hepatotoxicity, drug-induced liver injury, hepatocellular injury, hepatic steatosis, and hepatitis cholestatic have been uncommonly reported with NINLARO. Monitor hepatic enzymes regularly and adjust dose for Grade 3 or 4 symptoms.

Pregnancy- NINLARO can cause fetal harm. Advise male and females patients of reproductive potential to use contraceptive measures during treatment and for an additional 90 days after the final dose of NINLARO. Women of childbearing potential should avoid becoming pregnant while taking NINLARO due to potential hazard to the fetus. Women using hormonal contraceptives should use an additional barrier method of contraception.

Lactation- It is not known whether NINLARO or its metabolites are excreted in human milk. There could be potential adverse events in nursing infants and therefore breastfeeding should be discontinued.

SPECIAL PATIENT POPULATIONS

Hepatic Impairment: Reduce the NINLARO starting dose to 3 mg in patients with moderate or severe hepatic impairment.

Renal Impairment: Reduce the NINLARO starting dose to 3 mg in patients with severe renal impairment or end-stage renal disease (ESRD) requiring dialysis. NINLARO is not dialyzable and, therefore, can be administered without regard to the timing of dialysis.

DRUG INTERACTIONS

Co-administration of strong CYP3A inducers with NINLARO is not recommended.

ADVERSE REACTIONS

The most frequently reported adverse reactions (≥ 20%) in the NINLARO regimen, and greater than in the placebo regimen, were diarrhea (42% vs. 36%), constipation (34% vs. 25%), thrombocytopenia (28% vs. 14%), peripheral neuropathy (28% vs. 21%), nausea (26% vs. 21%), peripheral edema (25% vs. 18%), vomiting (22% vs. 11%), and back pain (21% vs. 16%). Serious adverse reactions reported in ≥ 2% of patients included thrombocytopenia (2%) and diarrhea (2%). For each adverse reaction, one or more of the three drugs was discontinued in ≤ 1% of patients in the NINLARO regimen.

Study Finds Potential of Whole Breast Ultrasound Tomography to Improve Breast Cancer Risk Assessment

On March 10, 2020 Delphinus Medical Technologies, Inc., the leader in advanced breast ultrasound technology, has reported that results of a study comparing the use of whole breast ultrasound tomography (UST) and mammography to assess breast cancer risk have been published in the Journal of Clinical Medicine (Press release, Delphinus Medical Technologies, MAR 10, 2020, View Source [SID1234555376]). The study was conducted by researchers at the National Cancer Institute, the Karmanos Cancer Institute, Wayne State University, Henry Ford Health Systems, The Mayo Clinic and George Washington University and was supported by a contract from the National Cancer Institute, part of the National Institutes of Health.

Mammographic percent density (MPD) is an independent risk factor for developing breast cancer. MPD only modestly improves breast cancer risk prediction and is not typically assessed in women under 40 because of ionizing radiation concerns. Previous studies have shown that tissue sound speed, derived from UST, a non-ionizing modality, is a potential surrogate marker of breast density. But prior to this study, sound speed has not been directly linked to breast cancer risk. The study evaluated the relationship of sound speed, using Delphinus’ SoftVue 3D whole breast ultrasound system, and MPD with breast cancer risk in a case-control study. This study compared 61 patients with a recent breast cancer diagnosis with 165 women with no personal history of breast cancer.

This study demonstrated that increasing quartiles of whole breast volume-averaged sound speed were consistently and more strongly associated with increasing breast cancer risk than quartiles of mammographic percent density. These findings were statistically significant and suggest future opportunities for utilizing UST-breast cancer risk assessment, particularly in younger women with the absence of ionizing radiation.

"It is well-established that dense breast tissue is a breast cancer risk factor. This study suggests that whole breast ultrasound tomography may provide stronger and more specific information about that risk than mammography, which may ultimately help to stratify the risk in order to suggest more personalized screening and interventions," said Dr. Rachel Brem, Director, Breast Imaging and Intervention at The George Washington University and the Program Leader, Breast Cancer, at The George Washington Cancer Center. "We are encouraged by the study results that indicate the potential use of whole breast ultrasound to improve the accuracy of breast cancer risk assessment with a non-ionizing breast imaging modality."

Delphinus Chief Technology Officer, Dr. Neb Duric, added, "This study expands the potential application of our platform SoftVue technology beyond diagnostic imaging and breast cancer screening to cancer risk stratification for women at virtually any age, including the approximately 70 million women in the U.S. that are below screening age. We believe that SoftVue imaging may enable individual risk assessment and intervention at an early age, when interventions are the most effective, as well as personalized screening regimens that take into account risk levels."

Century Therapeutics Announces Opening of Seattle Innovation Hub

On March 10, 2020 Century Therapeutics, developer of induced pluripotent stem cell (iPSC)-derived allogeneic cell therapies for cancer, reported the opening of its Seattle-based Innovation Hub to develop next-generation product candidates that overcome barriers that have limited the effectiveness of cell therapies in solid tumor cancers (Press release, Century Therapeutics, MAR 10, 2020, View Source [SID1234555375]).

The site will advance the company’s novel iPSC science and allogeneic cell products by establishing expertise in data sciences and machine learning, synthetic biology, cancer biology and immuno-oncology. Century’s President of R&D, Hy Levitsky, M.D., will be based at the Seattle site, and together with Philadelphia-based Chief Scientific Officer Luis Borges, PhD., will oversee site operations and integration with the pipeline programs centered at Century’s Philadelphia headquarters.

"The Innovation Hub supports not only Century’s continued pipeline growth and development, but also our expansion into Seattle, a center of excellence in cell therapies," said Lalo Flores, Chief Executive Officer of Century Therapeutics. "I look forward to seeing the Century team grow, and am excited to have Luis and Hy leading the charge into this exciting new chapter."

Dr. Levitsky has extensive biotech industry experience, having previously served as Chief Scientific Officer at Juno Therapeutics in Seattle, as well as Head of Cancer Immunotherapy at Roche Pharma Research and Early Development. In addition, Dr. Levitsky earned his M.D. from Johns Hopkins University and has spent over 20 years on their faculty.

Dr. Borges has extensive cancer immunotherapy and cell therapy experience, having worked at Immunex, Amgen, Five Prime Therapeutics and Cell Medica, where as CSO he led the development of off-the-shelf CAR-cell therapies for the treatment of cancer in collaboration with the Baylor College of Medicine.

"Century’s new Seattle Innovation Hub will provide the infrastructure needed to conduct in-depth analytics of product candidates in preparation for entry into the pipeline portfolio," said Dr. Levitsky.

"The Hub will be key in realizing the potential of Century’s science to overcome limitations of first-generation cell therapies." Dr. Borges added, "The Seattle and Philadelphia research laboratories will complement each other. With our current deep expertise in iPSC biology, immunology, cell and protein engineering, the new group in Seattle will help us transition to future generation products designed to have potent anti-tumor efficacy and robust safety windows."

Seattle Genetics to Webcast Virtual Fireside Chat at Barclays Global Healthcare Conference

On March 10, 2020 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that Clay Siegall, Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the Barclays Global Healthcare Conference on Wednesday, March 11, 2020 at 4:20 p.m. Eastern Time (Press release, Seattle Genetics, MAR 10, 2020, View Source [SID1234555374]). The conference will be held in a virtual meeting format. The presentation will be webcast live and available for replay from Seattle Genetics’ website at www.seattlegenetics.com in the Investors section.