BRUKINSA Receives Positive Recommendation from NICE in U.K. for Adult Patients with Chronic Lymphocytic Leukemia
“We are delighted that NICE has recognized the clinical and economic benefit of BRUKINSA for patients with CLL,” said Dr. Robert Mulrooney, General Manager, U.K. & Ireland at BeiGene. “This follows the previous approval of BRUKINSA by NICE in July 2022 as the only cost-effective treatment for patients with Waldenstrom’s macroglobulinemia. Although we are a […]
Orphan Drug Designation (ODD) for resminostat (Kinselby) in CTCL in the European Union
Jason Loveridge, Ph.D., CEO of 4SC, commented: “CTCL is currently an incurable disease and patients are in great need of better therapies. Our recent RESMAIN trial has demonstrated strong efficacy data for resminostat (Kinselby). Receiving orphan drug designation provides us with a number of important benefits for resminostat (Kinselby), most crucially 10 years’ market exclusivity […]
COSELA (trilaciclib) Recommended in Updated SCLC Guidelines from the ASCO
“The inclusion of COSELA in these new ASCO SCLC guidelines is essential, as they inform treatment decisions by U.S. physicians caring for people living with small cell lung cancer,” said Raj Malik, M.D., Chief Medical Officer of G1 Therapeutics. “The mounting body of evidence from our clinical trials and real-world studies demonstrates the potential of […]
Global Registrational Phase III Study of Lisaftoclax in Treatment-Naïve Patients with CLL/SLL Approved by the China CDE
“In earlier studies, lisaftoclax combined with acalabrutinib has already demonstrated impressive efficacy and safety, validating the combination regimen’s therapeutic potential and its promise as a patient-centric treatment strategy,” said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. “We are very encouraged by this approval for the global registrational Phase III study of lisaftoclax combined […]
FDA Approves KEYTRUDA for Treatment of Patients With Resectable (T≥4 cm or N+) NSCLC in Combination With Chemo as Neoadjuvant Treatment, Then Continued as a Single Agent as Adjuvant Treatment After Surgery
“There remains a need for treatment options to improve outcomes for patients with earlier stages of non-small cell lung cancer,” said Dr. Heather Wakelee, principal investigator for KEYNOTE-671, thoracic medical oncologist and professor of medicine at Stanford University and past president of the International Association for the Study of Lung Cancer (IASLC). “This important milestone […]
European Commission Approves KEYTRUDA as Adjuvant Treatment for Adults With NSCLC at High Risk of Recurrence Following Complete Resection & Platinum-Based Chemo
“In the unfortunate scenario that non-small cell lung cancer recurs after surgery, most patients have to face limited palliative treatment strategies, underscoring the need to improve treatment outcomes for earlier stages of NSCLC,” said Dr. Solange Peters, chair of the medical oncology and thoracic malignancies department, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland. “This approval of […]
European Commission Approves ADCETRIS for the Treatment of Adult Patients with 1L CD30+ Stage III Hodgkin Lymphoma in Combination with AVD
“ECHELON-1 is the first trial to show a statistically significant improvement in overall survival outcomes for adult patients with Stage III & IV Hodgkin lymphoma in two decades, demonstrating the benefit ADCETRIS continues to bring to a broad group of patients,” said John Radford, M.D., FMedSci, University of Manchester and the Christie NHS Foundation, lead […]
FDA Approves Opdivo® (nivolumab) as Adjuvant Treatment for Eligible Patients with Completely Resected Stage IIB or Stage IIC Melanoma
“Following surgical removal of melanoma, patients may believe they are free of disease,” said John M. Kirkwood, M.D., Distinguished Professor of Medicine at the University of Pittsburgh School of Medicine and Co-Director of the Melanoma Center at UPMC Hillman Cancer Center. “However, within five years of diagnosis, one-third of patients with surgically resected stage IIB […]
Olema Oncology Announces Expansion of Collaboration Agreement with Novartis
“The amendment announced today significantly increases the size of our ongoing Phase 1/2 clinical study testing palazestrant in combination with ribociclib, in collaboration with Novartis,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. “With the Phase 1b dose escalation portion now successfully completed, we are currently in Phase 2 […]
MediLink Therapeutics Announces Strategic Collaboration And Worldwide License Agreement With BioNTech To Develop Next-Gen Anti-Cancer ADCs
“Under the terms of the agreement, MediLink will grant BioNTech exclusive global rights for the development, manufacturing, and commercialization of one of MediLink’s ADC assets excluding Mainland China, Hong Kong Special Administrative Region, and Macau Special Administrative Region. In exchange, BioNTech will provide MediLink with an upfront payment totaling of $70 million and additional development, […]
Specialised Therapeutics signs exclusive license agreement with CanariaBio for new ovarian cancer therapy
“Despite great advances in recent years, there remains a high unmet need in all our regions to treat this patient population. We look forward to working closely with our new partners at CanariaBio and pending the results of the pivotal Phase III registration study, making oregovomab available to eligible patients.”
Enrollment ex-China in Phase 3 REGAL Clinical Trial for Galinpepimut-S in AML Expected to be Completed in November 2023
“We are pleased to be so close to achieving this most important milestone – the completion of enrollment in the REGAL study – and, at the same time, it is important to note that we already have a sufficient number of patients enrolled for the pre-specified analyses,” said Angelos Stergiou, MD, ScD h.c., President and […]
Clinical trials of nanrilkefusp alfa as monotherapy and in combinations with pembrolizumab and cetuximab to be discontinued
“While we are disappointed with this outcome, we will continue to gather and analyze the full body of data from these studies to inform our future development plans for nanrilkefusp alfa, especially its potential utility in combination with other cancer immunotherapies,” said Richard Sachse, M.D., Ph.D., chief medical officer of SOTIO. “We are grateful to […]
First Patient Dosed in Phase Ib/II Trial of SLS009 (GFH009) in R/R PTCL
“SLS009 is a novel and highly selective CDK9 inhibitor which, to date, has shown tremendous therapeutic promise across multiple blood cancers,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “We are pleased with the initiation of the Phase Ib/II trial of SLS009 in the underserved PTCL patient population. Collaborating with […]
Enrollment in THIO-101 Phase II Clinical Trial Accelerated
“In feedback received from the clinical trial investigators, the encouraging efficacy observed in dosed patients is prompting physicians to speed up trial enrollment even further. Following U.S. Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application, we expect to more than double the number of sites in the near future,” said […]
Dose Escalation Completed in Phase 1 Trial of INB-100; Enrollment for the Phase 2 Trial of INB-400 in Newly Diagnosed GBM initiated
“These important enrollment milestones reflect our continued pursuit to achieve Cancer Zero by leveraging the power of the immune system to develop therapies to eradicate cancer,” said William Ho, Co-founder and CEO. “Our novel, synergistic immunotherapy approach has demonstrated promising early clinical results in patients with unmet medical needs. We look forward to progressing the […]
AbbVie acquires Mitokinin in its Neuroscience pipeline
Earlier this month, AbbVie acquired Mitokinin, a discovery-stage biotechnology company developing a disease modifying treatment for Parkinson’s Disease (PD). PD is a neurodegenerative movement disorder where dopaminergic neurons of the brain that control movement are preferentially lost, causing slowness in movement, rigidity of limbs and trunk, tremors, and postural instability. It affects over 10 million […]
New Data Demonstrating Superiority of TPST-1120 Arm Across Multiple Study Endpoints in Randomized 1L HCC Study presented
“This comprehensive analysis of more mature clinical data shows an even greater benefit than the earlier interim analysis of the TPST-1120 triplet therapy over standard of care alone, both for the entire study population and in subpopulations of patients, the latter of which was predicted by TPST-1120’s proposed mechanism of action,” said Stephen Brady, president […]
Pivotal KEYNOTE-671 Trial Meets Dual Primary Endpoint of OS in Resectable Stage II, IIIA or IIIB NSCLC
“This is a significant milestone in the treatment of resectable non-small cell lung cancer, as it represents the first Phase 3 study to show a statistically significant overall survival benefit for these patients with stage II, IIIA or IIIB (T3-4N2) non-small cell lung cancer. These results build upon the previously reported event-free survival data, and […]
Updated PC14586 Phase 1 Data Demonstrated Anti-Tumor Activity Across Multiple Solid Tumor Types With a TP53 Y220C Mutation
Dr. Schram commented, “Patients with a solid tumor harboring a TP53 Y220C mutation are in need of new treatment options, as currently there are no approved therapies targeting p53. The safety and efficacy data presented today demonstrate the potential of PC14586 to address a high unmet need in patients with TP53 Y220C-positive advanced solid tumors.”
Positive BEXMAB Study Update in Relapsed/Refractory AML and HMA-Refractory MDS Patients Announced
“The emerging data from Phase 1/2 continue to be extremely promising, showing continued good safety, encouraging efficacy and long durations of response,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron. “These results strongly support the planned next step of beginning enrollment of the Phase 2 part of the BEXMAB study.”
Interim Results from Phase 2 Clinical Trial of IT LSAM-PTX in the Treatment of Locally Advanced Pancreatic Cancer
“Pancreatic cancer is among the most lethal cancers with 5-year survival of only 12%,” said lead investigator and author, Neil Sharma, MD. “The interim results from this study, particularly the potential for downstaging and immunomodulation, are encouraging and warrant expanded studies to further evaluate the clinical benefit of neoadjuvant IT LSAM-PTX in combination with standard […]
Interim Safety and Immune Response Data from Phase 1/2 Clinical Trial of PDS0301 + Docetaxel in Metastatic Prostate Cancer announced
“We are encouraged by the preliminary data from the Phase 1/2 clinical trial evaluating PDS0301 in combination with docetaxel for patients with metastatic prostate cancer which has the potential to improve treatment outcomes for patients with advanced and refractory prostate cancers that have spread to other parts of the body,” said Lauren V. Wood, MD, […]
Data from two ongoing clinical studies with NUC-3373 in CRC announced
Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer, said: “We are delighted to have been able to showcase these data. For the first time, we have presented data from our lead program of NUC-3373 in second-line colorectal cancer from the NuTide:302 study, which has shown encouraging signs of efficacy and continues to demonstrate a […]
Positive Preliminary Data from Phase 1 Dose Escalation Portion of Phase 1/2 KB-0742 Study presented
“These positive preliminary efficacy and safety data underscore the promise of KB-0742 to treat patients with transcriptionally addicted tumors. The observed anti-tumor activity and absence of grade 3/4 neutropenia are particularly encouraging as we continue to enroll patients and explore a maximum tolerated dose,” said Jorge DiMartino, M.D., Ph.D., Chief Medical Officer and Executive Vice […]
Initial RLY-4008 (lirafugratinib) Data Demonstrating Durable Responses Across Multiple FGFR2-Altered Solid Tumors announced
“These data provide important early evidence that RLY-4008, or lirafugratinib, has the potential to help both patients with FGFR2-fusion cholangiocarcinoma as previously reported, as well as those with multiple other types of FGFR2-altered tumors,” said Don Bergstrom, M.D., Ph.D., President of R&D at Relay Therapeutics. “We are excited by the potential for lirafugratinib to help […]
FDA Orphan Drug Designation for SLS009 for Treatment of AML
“We are honored to receive the ODD from the FDA. This designation underscores the potential of SLS009 to address a significant unmet medical need for patients with AML,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “SLS009 is a novel and highly selective CDK9 inhibitor that has already shown a […]
Positive EU CHMP Opinion for KEYTRUDA + Chemo as 1L Treatment for HER2-Negative Advanced GEJ Adenocarcinoma Expressing PD-L1 (CPS ≥1)
“This positive CHMP opinion builds on our efforts to treat advanced gastric and gastroesophageal junction cancer in Europe, including in patients with HER2-negative disease, which accounts for the vast majority of gastric cancer cases,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. “We look forward […]
FDA Approves Pfizer’s BRAFTOVI + MEKTOVI for BRAF V600E-Mutant mNSCLC
“Today’s approval builds on our long-standing commitment to deliver innovative, personalized medicines to patients with lung cancer. By pursuing precision medicines that target a patient’s specific type of cancer, we are leveraging our deep understanding of tumor biology to help address the underlying cause of disease,” said Chris Boshoff, M.D., Ph.D., Chief Oncology Research and […]
Lilly to Acquire POINT Biopharma to Expand Oncology Capabilities into Next-Gen Radioligand Therapies
Joe McCann, Ph.D., CEO of POINT added: “The combination of POINT’s team, infrastructure and capabilities with Lilly’s global resources and experience could significantly accelerate the discovery, development and global access to radiopharmaceuticals. I look forward to a future where patients all over the world can benefit from the new cancer treatment options made possible by […]
