FDA Orphan Drug Designation for FORE8394 for the Treatment of Primary Brain and CNS Malignancies
“The receipt of Orphan Drug Designation is another important regulatory achievement that reinforces the FDA’s recognition of the potential of FORE8394 to improve clinical outcomes in patients with BRAF-altered brain tumors,” said Stacie Shepherd, M.D., Ph.D., Chief Medical Officer of Fore Biotherapeutics. “This designation will help us continue to expedite the development of our novel […]
BLA Submission for Lifileucel in Advanced Melanoma completed
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, “Completing our BLA submission for lifileucel is a critical step forward in our journey to deliver the first individualized, one-time cell therapy for a solid tumor. I would like to acknowledge the patients and physicians who participated in the C-144-01 clinical trial […]
QINLOCK® Included in NCCN Guidelines® for the Treatment of Second-Line GIST Patients and FDA Grants Breakthrough Therapy Designation for QINLOCK in Second-Line GIST Patients with Mutations in KIT Exon 11 and 17/18
“The Breakthrough Therapy Designation reflects the substantial clinical benefit of QINLOCK in second-line GIST patients harboring mutations in KIT exon 11 and 17/18 that we observed in the ctDNA analysis from the INTRIGUE Phase 3 study. If approved, we believe QINLOCK has the potential to become the standard-of-care for this group of second-line GIST patients […]
Calquence granted first regulatory approval in China for adults with previously treated mantle cell lymphoma
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “This approval for Calquence offers people living with mantle cell lymphoma in China an effective and tolerable new treatment option to help control their disease. As the first approval in China for Calquence, it is also an exciting step forward for AstraZeneca in blood cancers, […]
Retifanlimab Receives Accelerated FDA Approval for Merkel Cell Carcinoma
“More than a third of patients with MCC present with regional or distant metastases, which are associated with high rates of mortality,” said Dr. Shailender Bhatia, University of Washington and Fred Hutchinson Cancer Center. “The approval of Zynyz offers healthcare providers another first-line treatment option against MCC that can result in durable responses in patients […]
Caris Life Sciences and Incyte Enter Into Broad Precision Medicine Partnership to Advance Incyte’s Oncology Pipeline
“This partnership with Incyte will leverage Caris’ leading molecular science and technology solutions to support Incyte’s oncology research and development efforts,” said David Spetzler, M.S., Ph.D., MBA, President and Chief Scientific Officer of Caris Life Sciences. “The aggregate strength of our platform, which provides patient level DNA and RNA data both in tissue and blood, […]
Volastra Therapeutics in-licenses Clinical Stage KIF18A Inhibitor And Secures $60 Million in Series A Funding To Further Advance Cancer-Focused Pipeline
“We are excited to add sovilnesib to our growing pipeline of CIN-targeted therapeutics which includes our own KIF18A inhibitor, VLS-1488,” said Charles Hugh-Jones, Chief Executive Officer at Volastra.
Tachyon Receives Funding from CIRM for a Ph 1 Clinical Study of TACH101 in Patients with Advanced Solid Tumors
“Therapy resistance and metastatic dissemination are the main challenges in developing effective cancer treatments. Cancer stem cells and tumor-initiating cells play a significant role in this, and until now, have only been poorly characterized. We have completed extensive preclinical studies to support the clinical advancement of TACH101, and we have shown its ability to reduce […]
Celanese Announces Collaboration with Alessa Therapeutics for the Advancement of Oncology Treatments
“Our new collaboration with Alessa Therapeutics underscores our commitment to optimize therapeutics through drug delivery innovation for oncology patients,” said Karen Chen, Global Business Strategy Leader for Oncology at Celanese. “Delivery can be a fundamental, and oftentimes overlooked, part of a drug’s success, and we believe that our contribution to Alessa’s work can make a […]
First Patient Dosed in the I-SPY-P1 TRIAL in Breast Cancer
“Evorpacept is a potentially transformative approach to strengthen the anticancer immune response against breast cancer with minimal added toxicity,” said Laura Esserman, M.D., co-founder of Quantum Leap, Professor of Surgery and Radiology at the University of California San Francisco, CA. “The combination of a novel CD47 blocker with a HER2-directed ADC represents a promising strategy […]
Clinical Hold on XMT-2056 Ph 1 Clinical Trial Announced
“In line with our steadfast commitment to patient safety, we have been proactive in our response to this event. With the clinical hold in place, our efforts for XMT-2056 are now focused on undertaking the work required to fully analyze this SAE and consider potential next steps for development,” said Anna Protopapas, President and Chief […]
First Patient Dosed in Ph 1b/2a Trial Evaluating Bemcentinib in 1L NSCLC with STK11 Mutations
“Approximately 20% of non-squamous NSCLC patients harbor STK11m and do not currently have effective treatment options,” said Martin Olin, Chief Executive Officer of BerGenBio. “One specific attribute of this group is that they almost all demonstrate high levels of AXL activation. We are elated to have dosed the first patient in our trial and to […]
Enrollment initiated in Ph 1/2 Clinical Study of IMNN-001 in Combination with Avastin in Advanced Ovarian Cancer
Tyler Jacks, Ph.D., President of Break Through Cancer, Founding Director of MIT’s Koch Institute for Integrative Cancer Research, and the David H. Koch Professor of Biology said, “Break Through Cancer is excited to support this important study. Our foundation has brought together some of the nation’s top cancer research centers to collaborate, accelerate research and […]
Clinical Study of JWATM214 initiated in Patients with Advanced HCC
“This first-in-human study of JWATM214 aims to evaluate the safety and tolerability, determine the recommended phase 2 dose (RP2D), and evaluate the pharmacokinetic profile and preliminary efficacy of JWATM214 in adult patients with GPC-3-expressing advanced HCC.”
Ph 3 KEYNOTE-671 Trial Met Primary Endpoint of EFS in Patients With Resectable Stage II, IIIA or IIIB NSCLC
“Results from KEYNOTE-671 show that KEYTRUDA in combination with chemotherapy provided significant improvement in event-free survival, pathological complete response and major pathological response over chemotherapy alone as a perioperative treatment regimen for patients with resectable stage II, IIIA or IIIB non-small cell lung cancer,” said Dr. Eliav Barr, senior vice president, head of global clinical […]
Last Patient Enrolled in Pivotal METIS Study of Tumor Treating Fields in Brain Mets from NSCLC
“We are pleased to announce the completion of enrollment in the METIS study, our fourth pivotal study to complete enrollment in the last 17 months and our second study addressing non-small cell lung cancer,” said William Doyle, Novocure’s Executive Chairman. “Beginning with the top-line readout from the LUNAR study earlier this year, we expect a […]
Tagrisso demonstrated strong OS benefit in the ADAURA Ph 3 trial for adjuvant treatment of patients with early-stage EGFR-mutated lung cancer
Roy S. Herbst, MD, PhD, Deputy Director and Chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital, New Haven, Connecticut, and principal investigator in the ADAURA Phase III trial, said: “These new survival data for osimertinib reinforce the unprecedented ADAURA disease-free survival results and confirm its potential to extend patients’ lives in […]
Imfinzi significantly improved EFS in AEGEAN Ph 3 trial for patients with resectable NSCLC
John V. Heymach, MD, PhD. Professor and Chair Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, said: “Treating patients early with durvalumab both before and after surgery delivers a significant and clinically meaningful benefit in resectable non-small cell lung cancer, where new options are urgently needed to offer patients the […]
RXC004 Topline Data From Ph 2 Monotherapy Module leads to program discontinuation
“Our Phase 2 program is designed to explore the activity of RXC004 both as monotherapy and in combination with immune checkpoint inhibitors, consistent with its postulated dual mechanism of action. Our primary efficacy hypothesis is that in combination it can overcome immune evasion and anti-PD-1 resistance, which could open new patient segments,” said Dr Jane […]
KEYTRUDA + Chemo Significantly Improved OS vs chemo Alone as First-Line Treatment for Advanced Malignant Pleural Mesothelioma
“Malignant pleural mesothelioma is a rapidly progressing cancer that develops in the lining of the lungs and has a poor prognosis,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “Patients are in need of new treatments that can improve survival outcomes, and these positive […]
ACE-Breast-02 Pivotal Ph 3 Study of ARX788 for the Treatment of HER2 Positive Metastatic Breast Cancer Achieves Positive Results
Daniel O’Connor, Chief Executive Officer of Ambrx commented: “We congratulate our partner, NovoCodex, on this positive Phase 3 study. The positive results from this large Phase 3 study provide further support for our rationale to develop ARX788 globally in HER2 positive breast cancer patients.”
FAILED TRIAL: Ph 3 CONTACT-03 study of cabozantinib + atezolizumab versus cabozantinib alone in RCC patients did not meet primary endpoint of PFS
“Phase 3 CONTACT-03 study did not meet its primary endpoint of progression-free survival (PFS). CONTACT-03 evaluated cabozantinib (CABOMETYX®) in combination with atezolizumab versus cabozantinib alone in patients with locally advanced or metastatic clear cell or non-clear cell (papillary or unclassified only) renal cell carcinoma (RCC) who progressed during or after immune checkpoint inhibitor therapy (either […]
Enhertu Showed Clinically Meaningful and Durable Responses Across Multiple HER2-Expressing Tumour Types in DESTINY-PanTumor02 Ph 2 Trial
Cristian Massacesi, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca, said, “Enhertu has already demonstrated its potential to improve outcomes for patients with HER2-targetable breast, gastric and lung cancers, and these positive initial results in other tumour settings with significant unmet need are very encouraging. The DESTINY-PanTumor02 results mark an important step forward in […]
FDA Advisory Committee Votes In Favour of the Clinical Benefit of Polivy Combination For People With 1L DLBCL
“Today’s committee decision to recognise the potential of this Polivy combination as a first-line treatment option is important since four in ten people with diffuse large B-cell lymphoma relapse or do not respond to initial treatment,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We believe the clinical […]
FDA Orphan Drug Designation Granted to Batiraxcept for the Treatment of Pancreatic Cancer
“Receiving Orphan Drug Designation is another important milestone for batiraxcept, and it underscores the significant unmet medical need in patients with pancreatic cancer, typically diagnosed at an incurable advanced stage with a 5-year survival rate of 11%1,” said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. “Three patients from our P1b trial are still […]
FDA Clearance of IND Application for Phase 1/2 Clinical Trial (Starlight-1) of EB103, a CD19-Targeted ARTEMIS® T Cell Therapy, to Patients with B-Cell Lymphomas
“We are thrilled to have received FDA clearance for our IND application for EB103, which will allow us to evaluate its safety and efficacy in a broader range of patients, including those who are typically excluded from other clinical trials, often due to cytokine release syndrome (CRS) and neurotoxicity,” said Dr. Cheng Liu, President and […]
IND Acceptance by FDA for MT-8421 ETB Program Targeting CTLA-4
“MT-8421 represents a novel approach to target CTLA-4 in a wholly distinct manner from the current monoclonal antibody approaches. MT-8421 was designed to eliminate CTLA-4-expressing Tregs in the tumor microenvironment (“TME”) through a direct cell-kill mechanism independent of the effector cell presence that antibodies rely upon while not effecting Tregs in the periphery, the major […]
Libtayo® (Cemiplimab) + Chemotherapy combo Receives Positive CHMP Opinion For The Treatment Of Advanced PD-L1 Positive NSCLC
“Specifically, the CHMP recommended the Libtayo combination be approved in the European Union (EU) for first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression. This includes patients that have no EGFR, ALK or ROS1 aberrations and whose tumors are metastatic or locally advanced and not candidates for definitive […]
FDA accepts sBLA and EMA Validates Application for Opdivo as an Adjuvant Treatment for Patients with Completely Resected Stage IIB or IIC Melanoma
“Melanoma can be a devastating diagnosis, and patients with stage IIB or IIC melanoma tend to be at high risk of disease recurrence. Approximately one third of stage IIB and half of stage IIC patients experience recurrence within five years after surgery,” said Gina Fusaro, PhD, vice president, development program lead, Bristol Myers Squibb. “The […]
NDA for Niraparib and Abiraterone Dual-Action Tablet Plus Prednisone in 1L BRCA mutated mCRPC submitted to FDA
“Patients with mCRPC and BRCA mutations face a more aggressive form of prostate cancer and high unmet needs in terms of treatment options. The data supporting this submission reinforce the importance of biomarker testing to identify the subgroups of patients that are most likely to respond to a targeted treatment option,” said Peter Lebowitz, M.D., […]
