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MedNess: bite-size biopharma and medtech news

6th April, 2022
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MedNess This Week
HIGHLIGHTS
 
Drug Approvals
Yescarta® Receives U.S. FDA Approval as First CAR T-cell Therapy for Initial Treatment of R/R Large B-cell Lymphoma (LBCL)
Christi Shaw, Chief Executive Officer of Kite: “Kite started with a very bold goal: creating the hope of survival through cell therapy. Today’s FDA approval brings that hope to more patients by enabling the power of CAR T-cell therapy to be used earlier in the treatment journey. This milestone has been years in the making. On behalf of the entire Kite community, we would like to thank the patients and physicians who have been on this journey with us. You are what drives us every day to explore the full potential of cell therapy.”
Regulatory News
U.S. FDA Accepts for Priority Review New Drug Application of Futibatinib for Advanced Cholangiocarcinoma
“This is a very important step towards our goal to deliver futibatinib to patients awaiting potential new treatment options,” says Teruhiro Utsugi, Senior Managing Director at Taiho Pharmaceutical. “The Taiho group, working as one, will continue to do its utmost to deliver this agent to those in need.”
FDA Partial Clinical Hold for TakeAim Leukemia Study of Emavusertib (CA-4948)
"We are committed to ensuring the safety of patients in our studies and to working collaboratively with the FDA to develop therapies that meaningfully improve and extend patients' lives," said James Dentzer, Chief Executive Officer of Curis. "Given the clinical profile of emavusertib observed to date, we are hopeful that the study can be resumed soon, after appropriate review. We continue to be confident in the potential of emavusertib to address the high unmet need of patients with AML or MDS."
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Trial Results
FAILED TRIAL: Ph 3 SKYSCRAPER-02 study in extensive-stage small cell lung cancer failed to meet co-primary endpoint of PFS improvement
“Today’s outcome is disappointing as we had hoped to continue building on the advances of Tecentriq in extensive stage small-cell lung cancer, which remains difficult to treat. We are thankful to all the patients and healthcare professionals involved in the study,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “We look forward to seeing additional data from the upcoming phase III trial in PD-L1-high non-small cell lung cancer based on the encouraging results from the CITYSCAPE study.”
Rucaparib Significantly Improves PFS In 1L Maintenance Treatment In Women With Ovarian Cancer Regardless Of Their Biomarker Status In Ph 3 ATHENA-MONO Trial
“The results from the ATHENA-MONO study of Rubraca in first-line maintenance treatment ovarian cancer exceeded our expectations in terms of significant improvement in PFS versus placebo in each of the primary efficacy populations, including the all-comers or intent-to-treat population,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We believe that the positive results from ATHENA-MONO demonstrate that Rubraca will provide an important new treatment option for women with advanced ovarian cancer in the first-line maintenance setting, and we look forward to submitting these data to the regulatory authorities in the US and Europe during Q2 and Q3 2022, respectively. Most importantly, I would like to thank the patients, physicians, and our colleagues whose commitment to this trial made these results possible, which now offer the potential to make a difference in the lives of many women with advanced ovarian cancer. We would also like to thank GOG and ENGOT for their partnership in conducting this large and very important trial.”
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Trial/Program Status
Ovarian Cancer FSHR-Mediated CER-T Ph 1 Trial initiated at Moffitt Cancer Center
Jose R. Conejo-Garcia, M.D., Ph.D., Chair of the Department of Immunology at Moffitt Cancer Center and co-inventor of the CER-T technology, added, "CAR-T therapies are rapidly becoming an important player in cancer therapy, and our lab has developed a technology that has the potential to target tumors by using an existing biological mechanism that is well understood. If our CER-T approach is successful, it could serve as a model for future targeted CAR-T therapies in other cancer types. The goal in cancer therapy has always been to kill cancer cells with limited damage to healthy tissue, and we look forward to seeing how this CER-T therapy may be able to accomplish that in solid tumors, which have historically proven challenging to eradicate with cell therapy."
Monotherapy Patient Received a Transplant in APVO436 Expansion Trial for the Treatment of Acute Myeloid Leukemia
"We are very pleased to report that a refractory secondary AML patient, after receiving APVO436 as monotherapy, experienced a significant reduction in bone marrow blasts, tolerated the treatment well, experienced clinical benefit and was therefore able to proceed to allogeneic transplant. Prior to trial entry, this patient had refractory disease after receiving multiple other lines of therapy and had a very poor prognosis. There were few therapeutic options left with which to fight the disease," said Justin Watts, MD, Associate Professor of Medicine, Chief, Leukemia Section at the University of Miami Sylvester Comprehensive Cancer Center and treating investigator. "Without APVO436, this patient would not have proceeded to transplant, a highly desirable outcome for patients with AML."
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MedNess Business
Onco-News
Sanofi and IGM Biosciences Announce Collaboration Agreement for Oncology, Immunology and Inflammation Targets
John Reed, M.D., Ph.D., Global Head of Research and Development, Sanofi, told, “We look forward to this collaboration with IGM Biosciences, a pioneer in a new class of antibody medicines for the treatment of cancer, immunology, and inflammatory diseases. The IGM Biosciences technology platform offers an exciting approach to developing high-avidity IgM antibodies that can efficiently bind and stimulate the activity of cell surface receptors. This unique platform has the potential to overcome historical limitations of conventional IgG antibodies when seeking agonists of some classes of receptors.”
Novartis to include PYLARIFY® (piflufolastat F18) in Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan) trials for the selection of patients with prostate cancer
“The FDA-approval of Novartis’ Pluvicto brings hope to patients and is an exciting advancement in the field of radiopharmaceutical oncology,” said Mary Anne Heino, President and CEO of Lantheus. “We look forward to collaborating to further explore how PSMA PET imaging agents, like PYLARIFY, may aid in increasing accessibility to PSMA-targeted therapeutics. As always, our goal is to Find, Fight and Follow serious medical conditions and improve patient outcomes.”
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Collated by: Richa Tewari, PhD 
Editors' Desk
Richa Tewari, PhD
Oncology News
Debarati Banik
HealthIT
Sohini Dutta
BioPharma News
MedNess Plus
Manoj Mishra
Neuroimmunology and immunotherapies
Shalini Roy Choudhury
Genes and Therapy
Managing Editor
Nisha Peter, PhD
Consulting Editor
 
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Content Editors: Richa Tewari , Esha Sehanobish , Rinki Saha ,  Shilpa Rawal, PhD ,  Debarati Banik  , Divyaanka Iyer , Arundithi Ananthanarayanan and Abhinav Dey 
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