European Commission approved INAQOVI® (oral decitabine and cedazuridine) for the treatment of adults with newly diagnosed acute myeloid leukaemia
“The EC approval is based on the results from the Phase 3 ASCERTAIN clinical trial investigating the pharmacokinetic exposure equivalence of the novel oral fixed-dose combination versus intravenous (IV) decitabine in AML patients1. The ASCERTAIN study met its primary endpoint, with the orally administered decitabine and cedazuridine fixed-dose combination showing pharmacokinetic exposure equivalence to a […]
European Commission Approves ORSERDU in Patients with ER+, HER2- Locally Advanced or Metastatic Breast Cancer with an Activating ESR1 Mutation
“We have long known that patients living with metastatic breast cancer need effective and tolerable options which treat their disease while enabling them to focus on the things that matter to them,” said Elcin Barker Ergun, CEO of the Menarini Group. “We are proud of delivering a new breast cancer treatment that offers efficacy in […]
Cancer early diagnosis and liquid biopsies: Are We There Yet?
The field of liquid biopsy-based cancer diagnostics stands at an inflection point, primed to enable earlier detection, precise monitoring, and tailored cancer management. Myriad companies, predominantly startups but also including seasoned diagnostics players, are steering rapid innovations through blood tests that analyse circulating tumor DNA, cells, and other cancer biomarkers. Central to this transformation is […]
Exelixis and Insilico Medicine Enter into Exclusive Global License Agreement for ISM3091
“ISM3091 represents a potentially best-in-class approach to inhibiting USP1, an important oncology target with broad applicability in BRCA-mutant tumors,” said Dana Aftab, Ph.D., Executive Vice President, Discovery and Translational Research and Chief Scientific Officer, Exelixis. “We believe preclinical data on ISM3091’s potent anti-tumor activity, tolerability, and pharmacokinetics set the compound apart from competing USP1 inhibitors […]
Ryvu Therapeutics’ Global Licensee Menarini to Expand Development of MEN1703 (SEL24) with a New Study in Advanced Diffuse Large B-Cell Lymphoma (DLBCL)
“We are excited to begin this Phase II study with our partner Menarini to address the critical unmet need in DLBCL,” said Pawel Przewiezlikowski, co-founder, largest shareholder, and CEO of Ryvu Therapeutics. “The extensive preclinical evidence of MEN1703 activity in multiple types of lymphomas sets a promising foundation for evaluating the molecule’s potential in DLBCL, […]
Nurix Announces Strategic Collaboration with Seagen Combining Technologies of Targeted Protein Degradation and Antibody-Drug Conjugation to Advance a New Class of Cancer Therapeutics
“By combining the tissue and tumor specificity of antibodies with highly potent and catalytic targeted degradation of cancer driver proteins, we believe that DACs may represent a next generation of cancer medicine for a wide range of solid tumors and hematologic malignancies,” said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. […]
Moderna and Immatics Announce Strategic Multi-Platform Collaboration to Develop Innovative Oncology Therapeutics
“We are excited to embark on this strategic collaboration with Immatics, a pioneer in developing innovative cancer immunotherapies. This partnership presents a groundbreaking opportunity to leverage our mRNA technology alongside Immatics’ TCR platform, potentially diversifying and augmenting the way we approach cancer treatment. We believe this collaboration will accelerate the development of novel oncology therapies […]
AbCellera Announces Collaboration with Incyte to Accelerate the Discovery and Development of Therapeutic Antibodies in Oncology
“We are excited to partner with Incyte, which has a track record of developing first-in-class medicines and bringing them to patients in need,” said Murray McCutcheon, Ph.D., Senior Vice President of Partnering at AbCellera. “We look forward to working as an extension of Incyte’s team to address complex antibody discovery challenges and accelerate the development […]
Patient Dosing with MT-302 initiated in Phase 1 Study for Advanced or Metastatic Epithelial Tumors
“Initiation of patient dosing with MT-302 is a major milestone for Myeloid in our effort to deliver better treatment options for patients living with solid tumors. We are leading the way with our proprietary approach to in vivo programming, including with many novel CAR constructs designed for selective expression in a wide range of immune […]
Clinical Hold Lift Plan of the HEMO-CAR-T IND is Accepted by FDA
Dr Vladislav Sandler, Chief Executive Officer, commented: “We are pleased that the FDA has agreed to our plan and preliminary test results to address their concerns regarding our HEMO-CAR-T IND application. We are now working hard to complete the schedule of work set out in the plan and to re-submit the IND as expeditiously as […]
Phase 2 EVOKE-02 Study Of Trodelvy + KEYTRUDA Demonstrates Promising Clinical Activity In 1L mNSCLC
“Patients with metastatic NSCLC continue to need novel treatment options. The data from the EVOKE-02 study gives us confidence in the clinical activity of sacituzumab govitecan in combination with pembrolizumab in first-line metastatic NSCLC patients,” said Byoung Chul Cho, MD, PhD, Professor in the Division of Medical Oncology at Yonsei Cancer Center, Yonsei University College […]
Datopotamab deruxtecan plus Imfinzi showed promising clinical activity in the 1L advanced NSCLC setting in TROPION-Lung04 Phase Ib trial
Cristian Massacesi, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca, said: “Following the positive high-level results of TROPION-Lung01, these initial TROPION-Lung04 results in the first-line setting reinforce our confidence in datopotamab deruxtecan as a potential treatment option for patients with advanced non-small cell lung cancer. Through our robust clinical programme we are eager to […]
Enhertu demonstrated strong and durable tumour responses in previously treated HER2-mutant advanced lung cancer in DESTINY-Lung02 Phase II trial
Pasi A. Jänne, MD, PhD, Director, Lowe Center for Thoracic Oncology and Belfer Center for Applied Cancer Science, Dana-Farber Cancer Institute, US, said: “The primary results from DESTINY-Lung02 demonstrate that Enhertu continues to show strong and durable tumour responses for patients treated at either dose. The favourable safety profile seen at the 5.4mg/kg dose continues […]
New Lumakras® (Sotorasib) Plus Chemotherapy Data In First-Line KRAS G12C NSCLC announced
“We are delighted to see the positive data from the global CodeBreaK 101 trial further validate our approach to move LUMAKRAS earlier within the treatment paradigm through novel therapeutic combinations,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “Notably, these results follow and further expand upon the Phase 2 […]
Patritumab Deruxtecan Demonstrated Clinically Meaningful and Durable Responses in Patients with EGFR-Mutated mNSCLC in HERTHENA-Lung01 Phase 2 Trial
“The results from HERTHENA-Lung01 provide compelling evidence of efficacy of patritumab deruxtecan in heavily pretreated patients with advanced EGFR-mutated non-small cell lung cancer,” said Helena Yu, MD, Associate Attending Physician, Memorial Sloan Kettering Cancer Center. “The clinically meaningful efficacy observed across a broad range of HER3 expression and diverse mechanisms of EGFR TKI resistance as […]
Quizartinib Recommended for Approval in EU by CHMP for Patients with Newly Diagnosed FLT3-ITD Positive AML
“Today’s positive CHMP opinion for quizartinib is an important step towards translating the clinical benefit observed in QuANTUM-First into an approved treatment option for patients in the EU with the difficult-totreat FLT3-ITD subtype of acute myeloid leukemia,” said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo. “If approved, quizartinib would be the first […]
Enhertu recommended for approval in the EU by CHMP for patients with HER2-mutant advanced NSCLC
Enhertu recommended for approval in the EU by CHMP for patients with HER2-mutant advanced NSCLC Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “HER2-mutant non-small cell lung cancer is an aggressive form of lung cancer that often affects younger patients and has a poor prognosis, with limited approved therapies. This milestone recognises the unmet […]
Positive EU CHMP Opinion for KEYTRUDA as Adjuvant Treatment for Adults with NSCLC at High Risk of Recurrence Following Complete Resection and Platinum-Based Chemo
“While KEYTRUDA is foundational in the treatment of metastatic non-small cell lung cancer, there continues to be an unmet need to help more patients with lung cancer in earlier stages of disease,” said Dr. Gregory Lubiniecki, vice president, global clinical development, Merck Research Laboratories. “The CHMP’s positive recommendation brings us one step closer to providing […]
Expedited Development Plan for BT8009 in Metastatic Bladder Cancer Announced
“We prepared a robust and innovative clinical development plan for BT8009, with the goal of getting this much-needed therapy to patients as quickly as possible. We are pleased to have reached alignment with the FDA on the registrational trial design, dose selection and clinical trial endpoints that could support potential accelerated approval in a broad […]
FDA Fast Track Designation for Tulmimetostat in Endometrial Cancer
“Receiving Fast Track designation from the FDA for tulmimetostat in ARID1A-mutated endometrial cancer underscores this investigational therapy’s potential in a patient population with limited treatment options,” said Tim Demuth, M.D., Ph.D., MorphoSys Chief Research and Development Officer. “The preliminary results from our Phase 1/2 study of tulmimetostat are very promising. We will continue to generate […]
WaveBreak’s Small-Molecule Inhibits Toxic Oligomers of alpha synuclein in Pre-clinical study
WTX-A is a small-molecule oral drug developed by WaveBreak. In a recent pre-clinical study, it efficiently blocked α-synuclein oligomers and aggregates in both cell and mouse models of Parkinson’s disease (PD) in a dose-dependent manner. Oligomers are toxic intermediate forms of abnormally folded proteins directly responsible for neurotoxicity in PD, Alzheimer’s Disease, and Amyotrophic Lateral […]
U.S. FDA Fast Track Designation for vididencel in Acute Myeloid Leukemia (AML)
“As part of the preparations for continued clinical development of vididencel in AML, we continue to strengthen the program in all product-relevant aspects, including on the regulatory front,” commented Jeroen Rovers, MD PhD, Chief Medical Officer of Mendus. “The Fast Track Designation granted by the FDA adds substantial regulatory value to the vididencel program in […]
MAA submitted to the EMA for Approval of Erdafitinib in Patients with Locally Advanced or Metastatic Urothelial Cancer with Susceptible FGFR Alterations
“For patients with advanced UC, including FGFR-driven tumours, outcomes remain poor and treatment options are limited; therefore, there is a need for novel, targeted therapies,” said Martin Vogel, EMEA Therapeutic Area Lead Oncology, Janssen-Cilag GmbH. “We are excited by the prospect of bringing innovative, personalised approaches to market for patients as we work towards our […]
Calquence approved in China for chronic lymphocytic leukaemia
Professor Li Jianyong, Director of Haematology, People’s Hospital of Jiangsu Province, and Leader of China CLL Working Group, said: “Many people living with chronic lymphocytic leukaemia experience relapse and need additional treatment options to help manage their disease. I’m delighted that with this approval patients now have access to an established treatment that has already […]
KSQ Therapeutics and CTMC Announce Strategic Collaboration to Accelerate the Development of Novel Engineered Tumor Infiltrating Lymphocyte (eTIL) Therapies for the Treatment of Solid Tumors
“Our eTIL programs – which edit the SOCS1 and Regnase-1 genes – have the potential to be firstand best-in-class cell therapies for cancer treatment. As our eTIL programs move through INDenabling studies, our partnership with CTMC will have us ready to manufacture KSQ-001EX and KSQ-004EX for clinical studies,” said Qasim Rizvi, Chief Executive Officer of […]
Portage Biotech announces collaboration with Merck to evaluate two next-generation adenosine antagonists in combination with Keytruda® in solid tumors
“We are excited to initiate another collaboration with longstanding immunotherapy leader, Merck, to further explore the potential benefits of combining checkpoint blockade with PORT-6 and PORT-7,” said Dr. Ian Walters, Chief Executive Officer of Portage Biotech. “Our suite of potentially best-in-class adenosine antagonists are designed to act on multiple immune cell types for potentially more […]
OncoNano and Regeneron Enter into Clinical Trial Supply Agreement for Use of Libtayo® (cemiplimab) in ONM-501 Study
“We believe that our ONM-501 program, which leverages cyclic dinucleotide activation and polyvalent binding to STING to generate both a burst and a sustained immune response, has the potential to show an improved clinical profile as compared to earlier experimental STING agonists,” said Kartik Krishnan, M.D., Ph.D., Chief Medical Officer of OncoNano Medicine. “We are […]
First Patient Dosed in Phase 1/2 Trial of BEAM-201 in Relapsed, Refractory T-ALL/T-LL
“As the first patient dosed with a Beam therapeutic candidate and the first patient in the U.S. to receive a base editing therapeutic, this represents a major milestone for the company, the scientists that made this possible, and the patients we hope to serve,” said John Evans, chief executive officer of Beam. “We believe that […]
TIVDAK® (tisotumab vedotin-tftv) Met its Primary Endpoint of Improved OS in Patients with Recurrent or Metastatic Cervical Cancer Compared to Chemotherapy
“TIVDAK is the only U.S. Food and Drug Administration-approved therapy in second-line recurrent or metastatic cervical cancer regardless of biomarker status, tumor histology and prior therapy,” said Roger Dansey, M.D., President of Research and Development and Chief Medical Officer at Seagen. “Demonstrating a survival benefit with the results of innovaTV 301 is a critical milestone […]
Phase 3 MARIPOSA-2 Study Meets Dual Primary Endpoint Resulting in Improvement in PFS for RYBREVANT® (amivantamab-vmjw) + Chemo +/- Lazertinib vs chemo Alone in Patients with EGFR-Mutated NSCLC after Disease Progression on Osimertinib
“MARIPOSA-2 provides the first Phase 3 study data of RYBREVANT-based regimens in the broader EGFR-mutated non-small cell lung cancer population,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “The study builds on the significant innovation of RYBREVANT, a first-in-class bispecific antibody targeting two major oncogenic driver pathways, with […]
