Castle Biosciences Collaborates with the Melanoma Research Foundation for “Ask the Expert” Live Webinar Series with Melanoma Experts

On April 1, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported it will collaborate with the Melanoma Research Foundation (MRF) to present "Ask the Expert" Managing Melanoma, a webinar series, throughout the month of April (Press release, Castle Biosciences, APR 1, 2021, View Source [SID1234577514]).

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The MRF is the largest independent organization dedicated to melanoma research, education of patients and their caregivers and advocacy on both the federal and state-level. The "Ask the Expert" Managing Melanoma series is aimed at increasing awareness and engagement in the melanoma community and will feature leading dermatologists and melanoma experts.

The Facebook Live webinars are accessible to the public and will take place on the MRF Facebook page with the following industry leaders:

April 6, 2021 @ 3 p.m. E.T.: Abel Jarrell, M.D., dermatology/dermatopathology, Melanoma Patient Journey
April 13, 2021 @ 4 p.m. E.T.: Brent Moody, M.D., Mohs surgeon, Familial Genetics vs. Tumor Genetics
April 20, 2021 @ 4 p.m. E.T.: Shannon Trotter, D.O., dermatology, Use of Gene Expressing Profiling in Melanoma Prognosis
April 27, 2021 @ 3 p.m. E.T.: Steven Trocha, M.D., surgical oncologist, Lifetime Clinic for High-Risk Melanoma Patients
"Disease awareness, preventive methods and early detection are all key factors that contribute to the best patient outcomes," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We are proud to support the MRF and its ‘Ask the Expert’ sessions to provide additional resources for patients and educate the public on melanoma and on the role of tumor biology and genomic testing in informing cancer treatment plan decisions for this aggressive form of skin cancer."

"Our mission is to prevent melanoma in as many people as possible," said Kyleigh Lipira, M.B.A., chief executive officer of the MRF. "Our work with Castle complements our goal of providing the necessary insight and resources to vigilantly prevent and detect melanoma."

For more information on the "Ask the Expert" Facebook Live webinars, or to access a recorded playback of the sessions, please visit the MRF Facebook page here.

Novocure to Report First Quarter 2021 Financial Results

On April 1, 2021 Novocure (NASDAQ: NVCR) reported that it will report financial results for the first quarter 2021 on Thursday, April 29, 2021, before the U.S. financial markets open (Press release, NovoCure, APR 1, 2021, View Source [SID1234577513]). Novocure’s management will host a conference call and webcast to discuss its financial results for the three months ended March 31, 2021, at 8 a.m. EDT on Thursday, April 29, 2021. Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 2286525.

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The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

Kite Submits Supplemental Biologics License Application to U.S. Food and Drug Administration for Tecartus® in Adult Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

On April 1, 2021 Kite, a Gilead Company (Nasdaq: GILD), reported that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Tecartus (brexucabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) (Press release, Kite Pharma, APR 1, 2021, View Source [SID1234577512]). The sBLA is supported by data from the Phase 1/2 ZUMA-3 trial, which are also being submitted for presentation at an upcoming scientific congress.

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In 2017, Tecartus was granted Breakthrough Therapy Designation by the FDA for relapsed or refractory adult B-cell precursor ALL. If approved, Tecartus would become the first and only chimeric antigen receptor (CAR) T-cell therapy approved for adults (≥18 years old) with relapsed or refractory ALL.

"Tecartus has already begun to transform the outlook for many patients with relapsed or refractory mantle cell lymphoma, and we’re encouraged by the data we’ve seen in adult patients with relapsed or refractory ALL, as survival rates among these patients remain poor with the most commonly used therapeutic agents," said Frank Neumann, MD, PhD, Kite’s Global Head of Clinical Development. "We are working closely with the FDA to progress our application and to bring the benefits of CAR T to patients with this particularly intractable leukemia."

In July 2020, Tecartus became the first and only CAR T-cell therapy to receive accelerated approval from the FDA for the treatment of relapsed or refractory mantle cell lymphoma, based on overall response rate and durability of response. The Tecartus U.S. Prescribing Information has a Boxed Warning in its product label regarding the risks of cytokine release syndrome (CRS) and neurologic toxicities, and Tecartus is approved with a risk evaluation and mitigation strategy (REMS) due to these risks; see below for Indication and Important Safety Information.

Tecartus has not been approved by any regulatory agency for the treatment of adult patients with relapsed or refractory ALL. Its safety and efficacy have not been established in this indication.

About ALL

ALL is an aggressive type of blood cancer which can also involve the lymph nodes, spleen, liver, central nervous system and other organs. Approximately 1,200 adults are treated annually for relapsed or refractory ALL. Survival rates remain very poor in adult patients with relapsed or refractory ALL, with a median overall survival of approximately eight months with the most commonly used therapeutic agents.

B-cell precursor ALL is the most common form of ALL, accounting for approximately 75 percent of cases. Treatment for this form of ALL is typically associated with inferior outcomes compared with other types of ALL.

About ZUMA-3

ZUMA-3 is an ongoing international multicenter, registrational Phase 1/2 study in adult patients (≥18 years old) with ALL whose disease is refractory to or has relapsed following standard systemic therapy or hematopoietic stem cell transplantation. The objectives of the study are to evaluate the safety and efficacy of Tecartus in this patient population.

About Tecartus

Tecartus is an autologous, anti-CD19 CAR T cell therapy. Tecartus uses the XLP manufacturing process that includes T cell enrichment, a necessary step in certain B-cell malignancies in which circulating lymphoblasts are a common feature. In addition to adult ALL, Tecartus is also currently being evaluated in a Phase 1/2 trial in chronic lymphocytic leukemia (CLL) and pediatric ALL. The use of Tecartus in adult ALL, pediatric ALL and CLL is investigational, and its safety and efficacy have not been established in these cancer types.

Tecartus Indication

Tecartus is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

U.S. IMPORTANT SAFETY INFORMATION

BOXED WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITIES

Cytokine Release Syndrome (CRS), including life-threatening reactions, occurred in patients receiving Tecartus. Do not administer Tecartus to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
Neurologic toxicities, including life-threatening reactions, occurred in patients receiving Tecartus, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with Tecartus. Provide supportive care and/or corticosteroids as needed.
Tecartus is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta and Tecartus REMS Program.
Cytokine Release Syndrome (CRS), including life-threatening reactions, occurred following treatment with Tecartus. In ZUMA-2, CRS occurred in 91% (75/82) of patients receiving Tecartus, including ≥ Grade 3 CRS in 18% of patients. Among the patients who died after receiving Tecartus, one had a fatal CRS event. The median time to onset of CRS was three days (range: 1 to 13 days) and the median duration of CRS was ten days (range: 1 to 50 days). Among patients with CRS, key manifestations (>10%) included fever (99%), hypotension (60%), hypoxia (37%), chills (33%), tachycardia (37%), headache (24%), fatigue (19%), nausea (13%), alanine aminotransferase increased (13%), aspartate aminotransferase increased (12%), and diarrhea (11%). Serious events associated with CRS included hypotension, fever, hypoxia, acute kidney injury, and tachycardia.

Ensure that a minimum of two doses of tocilizumab are available for each patient prior to infusion of Tecartus. Following infusion, monitor patients for signs and symptoms of CRS daily for at least seven days at the certified healthcare facility, and for four weeks thereafter. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated.

Neurologic Toxicities, including those that were life-threatening, occurred following treatment with Tecartus. In ZUMA-2, neurologic events occurred in 81% of patients, 37% of whom experienced Grade ≥3 adverse reactions. The median time to onset for neurologic events was six days (range: 1 to 32 days). Neurologic events resolved for 52 out of 66 (79%) patients with a median duration of 21 days (range: 2 to 454 days). Three patients had ongoing neurologic events at the time of death, including one patient with serious encephalopathy. The remaining unresolved neurologic events were either Grade 1 or Grade 2. Fifty-four (66%) patients experienced CRS by the onset of neurological events. Five (6%) patients did not experience CRS with neurologic events and eight patients (10%) developed neurological events after the resolution of CRS. 85% of all treated patients experienced the first CRS or neurological event within the first seven days after Tecartus infusion.

The most common neurologic events (>10%) included encephalopathy (51%), headache (35%), tremor (38%), aphasia (23%), and delirium (16%). Serious events including encephalopathy, aphasia, and seizures occurred.

Monitor patients daily for at least seven days at the certified healthcare facility and for four weeks following infusion for signs and symptoms of neurologic toxicities and treat promptly.

REMS Program: Because of the risk of CRS and neurologic toxicities, Tecartus is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta and Tecartus REMS Program which requires that:

Healthcare facilities that dispense and administer Tecartus must be enrolled and comply with the REMS requirements. Certified healthcare facilities must have on-site, immediate access to tocilizumab, and ensure that a minimum of two doses of tocilizumab are available for each patient for infusion within two hours after Tecartus infusion, if needed for treatment of CRS.
Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer Tecartus are trained in the management of CRS and neurologic toxicities. Further information is available at www.YescartaTecartusREMS.com or 1-844-454-KITE (5483).
Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur due to dimethyl sulfoxide (DMSO) or residual gentamicin in Tecartus.

Severe Infections: Severe or life-threatening infections occurred in patients after Tecartus infusion. In ZUMA-2, infections (all grades) occurred in 56% of patients. Grade 3 or higher infections, including bacterial, viral, and fungal infections, occurred in 30% of patients. Tecartus should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.

Febrile neutropenia was observed in 6% of patients after Tecartus infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.

In immunosuppressed patients, including those who have received Tecartus, life-threatening and fatal opportunistic infections, including disseminated fungal infections (eg, candida sepsis and aspergillus infections) and viral reactivation (eg, human herpes virus-6 [HHV-6] encephalitis and JC virus progressive multifocal leukoencephalopathy [PML]) have been reported. The possibility of HHV-6 encephalitis and PML should be considered in immunosuppressed patients with neurologic events and appropriate diagnostic evaluations should be performed.

Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

Prolonged Cytopenias: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and Tecartus infusion. In ZUMA-2, Grade ≥3 cytopenias not resolved by Day 30 following Tecartus infusion occurred in 55% of patients and included thrombocytopenia (38%), neutropenia (37%), and anemia (17%). Monitor blood counts after infusion.

Hypogammaglobulinemia and B-cell aplasia can occur in patients receiving treatment with Tecartus. In ZUMA-2, hypogammaglobulinemia occurred in 16% of patients. Monitor immunoglobulin levels after treatment with Tecartus and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement. The safety of immunization with live viral vaccines during or following Tecartus treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least six weeks prior to the start of lymphodepleting chemotherapy, during treatment, and until immune recovery following treatment with Tecartus.

Secondary Malignancies may develop. Monitor life-long for secondary malignancies. In the event that one occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

Effects on Ability to Drive and Use Machines: Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following Tecartus infusion. Advise patients to refrain from driving and engaging in hazardous activities, such as operating heavy or potentially dangerous machinery, during this period.

Adverse Reactions: The most common adverse reactions (incidence ≥ 20%) were pyrexia, CRS, hypotension, encephalopathy, fatigue, tachycardia, arrhythmia, infection – pathogen unspecified, chills, hypoxia, cough, tremor, musculoskeletal pain, headache, nausea, edema, motor dysfunction, constipation, diarrhea, decreased appetite, dyspnea, rash, insomnia, pleural effusion, and aphasia. Serious adverse reactions occurred in 66% of patients. The most common serious adverse reactions (> 2%) were encephalopathy, pyrexia, infection – pathogen unspecified, CRS, hypoxia, aphasia, renal insufficiency, pleural effusion, respiratory failure, bacterial infections, dyspnea, fatigue, arrhythmia, tachycardia, and viral infections.

City of Hope and Hospital Israelita Albert Einstein Sign Agreement to Advance Cancer Care in Latin America

On April 1, 2021 City of Hope, a world-renowned independent research and treatment center for cancer and diabetes, reported that it will extend its leading-edge cancer expertise to South America via an education agreement with Hospital Israelita Albert Einstein, a top cancer center in Latin America (Press release, City of Hope, APR 1, 2021, View Source [SID1234577511]).

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The three-year agreement calls for City of Hope to share its specialized cancer expertise with Hospital Israelita Albert Einstein’s oncology residents and clinical staff. City of Hope will provide educational experiences and host multidisciplinary tumor boards. Both institutions will explore potential innovative collaborations in precision oncology and research.

"This agreement marks another milestone moment, allowing City of Hope to extend its mission to eliminate cancer to a new continent," said Harlan Levine, M.D., president of strategy and business ventures at City of Hope, which is headquartered near Los Angeles.

"Hospital Israelita Albert Einstein has an exceptional medical team," Levine added. "City of Hope will offer our best-in-class expertise as a comprehensive cancer center to both their residents in training and clinical staff. We hope to collaborate with our Latin American colleagues to improve cancer care outcomes not only in São Paulo, but also throughout Brazil and Latin America."

Among other services, City of Hope will provide a virtual multidisciplinary tumor board that will initially focus on gastrointestinal, genitourinary, lung and brain cancers. Hospital Israelita Albert Einstein physicians will share specific patient cases with complex issues involving molecular diagnostics, immunotherapy and innovations in cancer care delivery for review and discussion. City of Hope will also provide educational webinars and offer professional training on topics such as genetic testing, supportive care services and nursing.

Sidney Klajner, M.D., Ph.D., president of Hospital Israelita Albert Einstein, said, "We will incorporate City of Hope’s multidisciplinary approach to oncology precision medicine to address the cancer burden in Brazil. Together with City of Hope, we hope to collaborate on molecular diagnostics and innovative care advancements for the benefit of patients in Latin American and beyond."

Hospital Israelita Albert Einstein has been ranked as the best hospital in Latin America by the America Economia Business Intelligence Unit for 12 years in a row. Additionally, it is positioned 36th overall globally and 21st for specialized oncology on Newsweek’s ranking of the World’s Best Hospitals 2021.

This collaborative agreement was made possible through efforts by City of Hope’s Center for International Medicine (CIM), which seeks to collaborate with international organizations to improve cancer and diabetes care for more people worldwide. CIM works with governments, hospitals, private companies and investors, and offers a range of services in the areas of clinical research and innovation, education and professional development.

McKesson Corporation to Announce Fourth Quarter Fiscal 2021 Results on May 6, 2021

On April 1, 2021 McKesson Corporation (NYSE: MCK) reported that it will release its fourth quarter fiscal 2021 financial results after market close on Thursday, May 6, 2021 (Press release, McKesson, APR 1, 2021, View Source [SID1234577509]). The company will host a live webcast of the earnings conference call for investors at 4:30 PM Eastern Time to review its financial results.

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The live webcast will be available on McKesson’s Investor Relations website at View Source, along with the company’s earnings press release, financial tables and slide presentation.