Interim Analysis of Ph 2 Basket Trial of Milademetan for MDM2-Amplified Advanced Solid Tumors (MANTRA-2) provided
“We are encouraged by the preliminary observations from the MANTRA-2 trial,” said Avanish Vellanki, co-founder and chief executive officer of Rain. “Treatment with milademetan led to tumor regression in patients previously treated with a multitude of therapies across a range of cancers. We look forward to expanding this dataset as the trial continues to enroll.”
COM701 (anti-PVRIG) in Combination with Nivolumab Demonstrates Preliminary Anti-Tumor Activity and Potent Immune Activation in Metastatic MSS-CRC Patients
“MSS-CRC is a cold tumor that is typically not responsive to immunotherapy, especially in MSS-CRC patients with liver metastases representing about 70% of all CRC patients,” said CRC expert and presenting author, Dr. Michael Overman. “The data we will present at SITC, are encouraging and address this non-immune responsive subset of CRC. Adding COM701 to […]
Positive 1-Year and 2-Year Overall Survival Data for Patients with Relapsed or Refractory AML in Ph 1 Actimab-A CLAG-M Combination Trial Announced
Dr. Sameem Abedin, Assistant Professor at Froedtert & Medical College Wisconsin and Principal Investigator of the Study, commented, “The median overall survival of 12 months and 2-year overall survival of 32% is highly impressive in these relapsed or refractory patients, where a majority of treated patients have adverse cytogenetics including TP53 mutations and received prior […]
Initial Results From Ph 2 Trial Demonstrate Potential Of Trilaciclib To Reduce Adverse Events Related To An Antibody Drug Conjugate (ADC)
“Though the data are preliminary, we are seeing encouraging and consistent reductions in the rate of adverse events related to use of sacituzumab govitecan-hziy when trilaciclib is administered prior to the ADC, relative to the previously published single agent safety profile of this ADC, including those related to myelosuppression,” said Raj Malik, M.D., Chief Medical […]
Promising Initial Dose-Escalation Results from Ph 1 JEWEL-101 Trial Evaluating XB002 in Patients with Advanced Solid Tumors announced
“Following promising preclinical data, it is encouraging to see that XB002 was well-tolerated across multiple dose levels with a pharmacokinetic analysis supporting the ability of XB002 to remain stable after infusion and reach its target before releasing its cytotoxic payload,” said Susanna Ulahannan, M.D., M.Med., Assistant Professor of Medicine in the Section of Hematology/Oncology, University […]
Promising SRF388 Monotherapy Data in NSCLC announced, Opening Second Stage of Monotherapy Trial and NSCLC Pembrolizumab Combination Cohort
“We are excited by the monotherapy activity seen with SRF388 in relapsed non-small cell lung cancer (NSCLC), an area of high unmet need globally,” said Rob Ross, M.D., chief executive officer. “Two patients with squamous NSCLC have had confirmed partial responses to monotherapy treatment. Both patients had progressed on multiple prior systemic treatments, including anti-PD-(L)1 […]
Elranatamab Granted FDA Breakthrough Therapy Designation for Relapsed or Refractory Multiple Myeloma
“The FDA’s Breakthrough Designation recognizes the potential of elranatamab as an innovative medicine for people with multiple myeloma whose disease has relapsed or is refractory to existing treatments, which at present leaves very few avenues for staving off this currently incurable cancer,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology and Rare Disease, Pfizer […]
Innovation Passport Designation granted to Biologic CAR T-Cell Therapy Engager ALETA-001
“This designation for our biologic CAR T-cell therapy engager ALETA-001 marks an important step in addressing the high unmet need for patients who relapse or progress following CD19-targeted CAR T-cell therapy for blood cancers, such as lymphoma and leukemia,” stated Paul Rennert, Co-Founder, Acting Chief Executive Officer and Chief Scientific Officer, Aleta Biotherapeutics. “In collaboration […]
Imfinzi and Imjudo with chemotherapy approved in the US for patients with mNSCLC based on POSEIDON Phase III trial results
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “This approval underscores the importance of delivering novel treatment combinations that extend survival in metastatic non-small cell lung cancer, a complex setting where many patients still face a dismal prognosis. This marks the second indication for Imjudo added to Imfinzi in just a few weeks […]
FDA approves cemiplimab (Libtayo) with platinum-based chemotherapy for the treatment of advanced NSCLC patients with WT EGFR, ALK, or ROS1
“This second FDA approval for cemiplimab-rwlc in advanced non-small cell lung cancer greatly broadens the scope in which a cemiplimab-rwlc-based regimen can be prescribed to encompass a wide range of patients, either as single agent in those with PD-L1 ≥50% or now in combination with chemotherapy irrespective of PD-L1 expression or tumor histology,” said David […]
BeiGene Receives European Commission Approval for BRUKINSA® (zanubrutinib) for the Treatment of Adults with Marginal Zone Lymphoma
“We are proud of what this approval means for European MZL patients, who previously did not have an approved BTK inhibitor as a treatment option for this rare hematological malignancy,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. “This milestone builds on the track record we’ve built with BRUKINSA to date, with […]
Recommendations of the advisory committee on pneumococcal immunization practices
“Currently, the 13-valent pneumococcal conjugate vaccine (PCV13) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23) are recommended for U.S. children, and the recommendations vary by age group and risk group. Use of PCV15 as an alternative to PCV13 is expected to further reduce pneumococcal disease incidence in children and adolescents. PCV15 as an option for pneumococcal […]
New recommendations for influenza vaccine composition
“The World Health Organization has announced the recommended viral composition of influenza vaccines for the 2023 southern hemisphere influenza season. The recommendations issued today will be used by national vaccine regulatory agencies and pharmaceutical companies to develop, produce, and license influenza vaccines for the following influenza season. The periodic update of viruses contained in influenza […]
Obsidian Therapeutics Announces Extension of Multi-Year Collaboration Agreement with BMS
“We are delighted to extend our productive strategic partnership with Bristol Myers Squibb, an industry leader in the field, to advance next-generation cell therapies to patients with solid tumors and other malignancies,” said Paul K. Wotton, Ph.D., Chief Executive Officer of Obsidian Therapeutics. “This announcement comes at an exciting time for Obsidian as our own […]
Candel Therapeutics Partners with the University of Pennsylvania’s Center for Cellular Immunotherapies to Study Combinations of Novel Viral Immunotherapy and CAR-T Cell Therapy in Solid Tumor Models
“We are delighted to establish this discovery partnership with Penn as a first step towards evaluating the impact of innovative viral immunotherapies in combination with CAR-T cells with the aim of modulating the tumor microenvironment in such a way that CAR-T cells can get into the solid tumor, stay functional, and eliminate tumor cells. Our […]
Adaptimmune Enhances Its Pipeline of Wholly Owned Cell Therapies for Cancer with Transfer of PRAME and NY-ESO Target Programs from GSK
“MAGE-A4, NY-ESO and PRAME are amongst the best-characterized and validated TCR T-cell targets in the solid tumor field. With full ownership of these affinity enhanced SPEAR T-cells against each of these targets, we will be able to bring the benefits of cell therapy to an even larger number of people with cancer,” said Adrian Rawcliffe, […]
Enrollment of Davoceticept Clinical Studies (NEON-1 and NEON-2) Terminated
“Patient safety remains our highest priority,” said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. “We have determined it is in the best interest of all patients to terminate enrollment in the davoceticept studies and we will continue to work with the U.S. Food and Drug Administration, Merck, the study Safety […]
First Patient Dosed in Landmark MYCHELANGELO™ I Trial of OTX-2002 in HCC and Other Solid Tumor Types Associated with the MYC Oncogene
“Today’s announcement marks a new era of therapeutic development utilizing precision genomic control intended to treat and cure serious diseases. As the first-ever Omega Epigenomic Controller™ (OEC) to be dosed in a patient, this milestone for OTX-2002 and the MYCHELANGELO clinical program represents a significant step forward on our mission to deliver a new approach […]
Ph 1b Trial of Breast Cancer Vaccine commenced at Cleveland Clinic
“We are excited to commence the second stage of the Phase 1 trials for our breast cancer vaccine,” stated Dr. Amit Kumar, Chairman and CEO of Anixa. “While the Phase 1a trial is ongoing, the results to date have given us the confidence to move into this next study earlier than planned.” Dr. Kumar added, […]
Camizestrant significantly improved PFS vs. Faslodex in SERENA-2 Ph 2 trial in advanced ER-positive breast cancer
Mafalda Oliveira, MD, PhD, Vall d‘Hebron Institute of Oncology in Barcelona, Spain and lead investigator in the SERENA-2 Phase II trial, said: “The results from SERENA-2 show that camizestrant provides a significant improvement in progression-free survival compared to fulvestrant, which has been used to treat patients with HR-positive breast cancer for almost twenty years. These […]
Capivasertib plus Faslodex significantly improved PFS vs. Faslodex in CAPItello-291 Ph 3 trial
Nicholas Turner, MD, PhD, Professor of Molecular Oncology at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust, London, UK, and principal investigator in the CAPItello-291 Phase III trial, said: “The CAPItello-291 Phase III trial results show capivasertib offers a clinically meaningful improvement in progression free survival for patients with HR-positive […]
Initial Dose-Escalation Results from the First-in-Human Ph 1 JEWEL-101 Trial Evaluating XB002 in Patients with Advanced Solid Tumors
“Following promising preclinical data, it is encouraging to see that XB002 was well-tolerated across multiple dose levels with a pharmacokinetic analysis supporting the ability of XB002 to remain stable after infusion and reach its target before releasing its cytotoxic payload,” said Susanna Ulahannan, M.D., M.Med., Assistant Professor of Medicine in the Section of Hematology/Oncology, University […]
Updated Findings from the Ph 2 SUMMIT Basket Trial of Neratinib in EGFR Exon 18-Mutant NSCLC Presented
Dr. Martínez, an investigator of the study from Hospital Quirón Deuxes, said, “We are very excited about these interim study results in patients with EGFR exon 18-mutant lung cancer, for whom treatment options are limited. This study shows that neratinib has the potential to be an efficacious and safe option to treat their disease, even […]
FAILED TRIAL: Ph 2 AMEERA-3 trial of amcenestrant in ER+/HER2- advanced or metastatic breast cancer did not meet primary endpoint of improving PFS
“This Phase 2 trial evaluated amcenestrant as a monotherapy in a patient population with advanced disease where limited treatment options remain. While we are disappointed with the AMEERA-3 results, we continue to investigate amcenestrant in patients with earlier stages of breast cancer with different tumor profiles and where different standard of care treatments are used.”
Preliminary Ph 1 Clinical Data from ARROS-1 Trial of NVL-520 for Patients with ROS1-Positive NSCLC reported
“Currently approved and investigational ROS1 TKIs are important treatment options for advanced ROS1 fusion-positive cancers. However, these drugs can have key limitations. These include the inability to treat on-target resistance and brain metastases effectively, and an association with neurologic adverse events,” said Alexander Drilon, M.D., Chief, Early Drug Development Service, Memorial Sloan Kettering Cancer Center […]
FDA grants Fast Track Designation for MT-101 for the Treatment of CD5+ R/R PTCL
“We are pleased that MT-101 has received Fast Track designation from the FDA,” said Michele Gerber, MD, MPH, Chief Medical Officer of Myeloid. “The designation speaks to the serious nature of CD5+ relapsed/refractory PTCL , an aggressive form of non-Hodgkin lymphoma, and the potential MT-101 has to transform the treatment paradigm of this disease. IMAGINE, […]
Zentalis Pharmaceuticals Announces First ZN-c3 Clinical Development Collaboration with Pfizer
“We are extremely excited to announce this investigational study, which we believe will benefit greatly from the expertise and support gained through our collaboration with Pfizer,” said Carrie Brownstein, M.D., Chief Medical Officer of Zentalis. “Combining ZN-c3 with the BEACON agents in this study represents an opportunity in our ZN-c3 clinical development program, alongside ongoing […]
Retrospective Analysis of Extended Treatment Benefit from Multiple Trials of Mirvetuximab Soravtansine in Ovarian Cancer presented
“We believe the study outcomes presented at ESGO support the potential benefit mirvetuximab can have for a subset of patients on a long-term basis and add to the strong, existing foundation of data that supports mirvetuximab’s potential to become the new standard of care for FRα-positive ovarian cancer,” said Anna Berkenblit, MD, Senior Vice President […]
Findings from First-in-Human Study of CBX-12 presented
“In this phase I study, CBX-12 demonstrated safety and tolerability, without significant gastrointestinal toxicity. We also saw signal of antitumor activity in multiple tumor types,” said principal investigator, Funda Meric-Bernstam, M.D., Chair of the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center.
Quizartinib Granted Priority Review in the U.S. for Patients with Newly Diagnosed FLT3-ITD Positive AML
“There is a need for new targeted therapy options for patients with acute myeloid leukemia and the results of the QuANTUM-First trial showed that quizartinib in combination with standard chemotherapy has potential to change the current standard of care for newly diagnosed patients with the historically difficult to-treat FLT3-ITD subtype,” said Ken Takeshita, MD, Global […]
