Fostrox + Lenvima demonstrates further improvement in durable clinical benefit in HCC, supporting the accelerated development plan
”Patients with advanced HCC, who have progressed on at least one prior line of treatment, is a difficult-to-treat population. Achieving durable clinical benefit for the majority of the patients with a good safety and tolerability profile, enables patients to benefit from the combination treatment longer. It provides us with added confidence in accelerating the fostrox […]
Successful Interim Analysis of Efficacy and Safety Data in Potentially Pivotal Study of Berubicin announced
“Having successfully reached this milestone, we believe that this recommendation reflects Berubicin’s acceptable efficacy and safety profile, as defined in the trial protocol, as of the interim analysis. Building on the foundation of strong enrollment laid by our team, our investigators and their patients, the independent findings of the DSMB add to the Phase 1 […]
FDA Clears IND Application for SENTI-202 for the Treatment of Relapsed or Refractory Hematologic Malignancies Including Acute Myeloid Leukemia
“Clearance of our IND application for SENTI-202 is a tremendous milestone and marks an important achievement for Senti as we transition to a clinical-stage therapeutics company,” said Timothy Lu, MD, PhD, Chief Executive Officer and Co-Founder of Senti Bio. “Our team has dedicated immense time and resources to developing our Gene Circuit technology from an […]
sBLA and NDA submitted for RYBREVANT® (amivantamab-vmjw) + Lazertinib for the Treatment of Patients with EGFR-Mutated NSCLC
“The combination of RYBREVANT® and lazertinib demonstrated statistically significant and clinically meaningful improvement in progression-free survival compared to osimertinib in patients with previously untreated EGFR-mutated NSCLC. This remains an area of high unmet need as patients often experience treatment resistance and disease progression on currently available therapies,” said Kiran Patel, M.D., Vice President, Clinical Development, […]
U.S. Food and Drug Administration Issues Complete Response Letter for Cosibelimab Solely Due to Inspection Findings at Third-Party Manufacturer
“As the only deficiencies relate to the FDA’s inspection of our third-party contract manufacturing organization, we believe we can address the feedback in a resubmission to enable marketing approval in 2024,” said James Oliviero, President and Chief Executive Officer of Checkpoint. “We are committed to working closely with our third-party manufacturer and the FDA on […]
EMA confirms recommendation for non-renewal of authorisation of multiple myeloma medicine Blenrep
“During the re-examination, the CHMP consulted a scientific advisory group (SAG) comprising of experts in the treatment of cancer. These experts were of the view that the DREAMM-3 study did not confirm the effectiveness of Blenrep. However, the majority of SAG experts were also of the opinion that Blenrep could be a treatment option for […]
FDA Breakthrough Therapy Designation for Antibody-Drug Conjugate Candidate BNT323/DB-1303 in Endometrial Cancer
“The Breakthrough Therapy designation for BNT323/DB-1303 shows the potential of our ADC candidate to address current treatment challenges for patients with advanced HER2-expressing endometrial cancer who progressed under several lines of systemic therapy. For these patients the survival rates are still low and the medical need for new and more effective treatments remains high,” said […]
Patritumab Deruxtecan Granted Priority Review in the U.S. for Certain Patients with Previously Treated Locally Advanced or Metastatic EGFR-Mutated NSCLC
“The FDA’s prioritization of the BLA submission reflects the strength of the data from HERTHENA-Lung01 and emphasizes the need to provide new options to patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer previously treated with two or more systemic therapies,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “If approved, patritumab […]
European Commission Approves KEYTRUDA + Chemotherapy for New 1L Indications in Advanced HER2-Negative Gastric or GEJ Adenocarcinoma in Tumors Expressing PD-L1 (CPS ≥1) and Advanced Biliary Tract Cancer
“KEYTRUDA has shown its potential as an important treatment option in the EU across a number of gastrointestinal cancers, with seven indications based on data from our extensive clinical development program,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. “With these two new approvals of […]
U.S. FDA Approves Label Update For Yescarta CAR T-Cell Therapy To Include OS Data
“This U.S. label update for Yescarta is an important step to reinforce healthcare provider confidence to treat eligible patients with Yescarta, immediately following progression or relapse in large B-cell lymphoma,” said Frank Neumann, MD, PhD, Senior Vice President and Global Head of Clinical Development, Kite. “Our ZUMA-7 overall survival analysis proves that when given as […]
FDA Approves Label Update for BRUKINSA® (zanubrutinib) in Chronic Lymphocytic Leukemia (CLL)
“The ALPINE trial is the first and only study to demonstrate PFS superiority in a head-to-head comparison versus ibrutinib in CLL,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. “BRUKINSA was approved in the U.S. for CLL at the beginning of 2023, and we submitted additional data from the ALPINE PFS analysis […]
CONFERENCE COVERAGE: American Society of Hematology (ASH) Annual Meeting 2023
Agenus to Receive $25 Million Milestone Payment from Bristol Myers Squibb for TIGIT-CD96 Bispecific Program
“The start of the phase 2 portion of the dose expansion study marks an exciting milestone for this differentiated anti-TIGIT program and an important step in potentially delivering a meaningful new option for cancer patients,” said Chief Executive Officer, Garo Armen, Ph.D. “Similar to our lead program botensilimab, we engineered this bispecific TIGIT antibody with […]
SystImmune and Bristol Myers Squibb Announce a Global Strategic Collaboration Agreement for the Development and Commercialization of BL-B01D1
“Recent BL-B01D1 trials have shown broad potential across different solid tumors as well as a manageable safety profile,” said Dr. Yi Zhu, Chief Executive Officer at SystImmune. “We have long admired Bristol Myers Squibb’s global clinical development and commercialization capabilities in oncology, and this strategic collaboration is an exciting step forward in delivering potential antitumor […]
Nona Biosciences Enters into a Global License Agreement with Pfizer for HBM9033, an MSLN-Targeted Antibody-Drug Conjugate (ADC)
“We are delighted to collaborate with Pfizer, a company that is committed to developing high-impact medicines for people living with cancer,” said Jingsong Wang, M.D., Ph.D., Chairman of Nona Biosciences. “This agreement represents a significant milestone in the advancement of our proprietary Harbour Mice® platform and the ADC ecosystem, affirming Nona’s robust capabilities and expertise […]
Glycotope and Evotec enter licensing agreement to combine Glycotope antibodies and Evotec’s immune cell engager platform
“The applicability of Glycotope antibodies to many different tumor indications, combined with good tumor selectivity makes them ideal targeting moieties for our novel, proprietary immune cell engager platform,” stated Dr Cord Dohrmann, Chief Scientific Officer of Evotec SE.
C4 Therapeutics Announces License and Research Collaboration with Merck to Discover and Develop Degrader-Antibody Conjugates (DACs)
“We are thrilled to collaborate with Merck to innovate within the growing field of antibody-drug conjugates and evaluate the potential for combining the catalytic efficiency, potency, target specificity, and durability of degraders with the specific binding and delivery capabilities of antibodies,” said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. “We look forward […]
Ph 3 INTerpath-002 Study of V940 (mRNA-4157) – KEYTRUDA combination for Adjuvant Treatment of Patients with Certain Types of Resected NSCLC
“As lung cancer is the leading cause of cancer death worldwide, there is a need for continued scientific advancements to help fight this disease at earlier stages when patients have the best chance for better outcomes,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. “By […]
First Patient Dosed in Phase 2b Clinical Trial of Samuraciclib in Combination with Fulvestrant in Patients with Advanced HR+, HER2- Breast Cancer
“We continue to make great progress in evaluating the combination of samuraciclib and fulvestrant with the dosing of the first patient in the Phase 2b study,” said Tim Pearson, Chief Executive Officer of Carrick Therapeutics. “There is a large unmet need in treatment for women with HR+, HER2- breast cancer, which represents more than two […]
First Patients Enrolled in 60 mg Dose Cohort in Phase 2a Clinical Trial of SLS009 in Acute Myeloid Leukemia
“We are thrilled with the Safety Monitoring Committee advocating that we proceed to the recommended Phase 2 dose level of 60 mg after finding no safety concerns with the 45 mg cohort, which represents important progress in the clinical advancement of SLS009. Based on the encouraging efficacy data and safety profile that continues to emerge […]
Enrollment of Phase II/III Trial of Fruquintinib in Combination with Sintilimab for Advanced Renal Cell Carcinoma in China completed
“The study is a randomized, open-label, active-controlled study to evaluate the efficacy and safety of fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy for the second-line treatment of advanced RCC. The primary endpoint is progression free survival (“PFS”) per RECIST 1.1 as assessed by blinded independent central review (BICR). The secondary endpoints include […]
CB-010 Phase 3 Trial Initiation Expected by YE 2024
“FDA feedback on our CB-010 pivotal development plan represents an important step in advancing our lead therapy to enable broader access of CAR-T cell therapies for patients living with large B cell lymphoma,” said Rachel Haurwitz, PhD, Caribou’s president and chief executive officer. “As our ongoing ANTLER trial progresses, we look forward to engaging again […]
Confirmatory Phase 3 Trial of Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer initiated
“LGSOC has a unique molecular, histologic, and clinical profile that differs dramatically from the most common type of ovarian cancer. Response rates to standard of care treatments are disappointing, and there are still no FDA approved treatments specifically for LGSOC,” said Rachel Grisham, M.D., Section Head, Ovarian Cancer and Director, Gynecologic Medical Oncology at Memorial […]
Patient Enrollment in Phase 2 Pancreatic Cancer Trial of CM24 Completed
“Having completed patient enrollment, we now look forward to reporting overall survival results in 2024. We thank the patients and their families for participating in this important and promising study, which may advance CM24 toward a pivotal study for a population in dire need of an effective alternative. Survival rates in pancreatic cancer are unfortunately […]
FAILED TRIAL: RELATIVITY-123 Trial Evaluating the Fixed-Dose Combination of Nivolumab and Relatlimab in Patients with Previously Treated MSS CRC unlikely to meet primary endpoint, to be discontinued
“Metastatic colorectal cancer is a challenging cancer to treat with high unmet needs. Though there have been advances in treating patients with microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) colorectal cancers, patients with microsatellite stable (MSS) tumors continue to have limited treatment options in later lines of therapy. While we know immunotherapies have historically demonstrated limited […]
mRNA-4157 (V940) + KEYTRUDA Combination Demonstrated Continued Improvement in RFS and DMFS in Patients with High-Risk Stage III/IV Melanoma Following Complete Resection Versus KEYTRUDA At Three Years
“As we continue to follow participants in the KEYNOTE-942/mRNA-4157-P201 study, we are excited to see such a robust clinical benefit with mRNA-4157 (V940) as adjuvant treatment in combination with KEYTRUDA in people with resected high-risk melanoma,” said Kyle Holen, M.D., Moderna’s Senior Vice President and Head of Development, Therapeutics and Oncology. “These data add another […]
Positive Data announced from CFT7455 Phase 1 Trial in Relapsed/Refractory Multiple Myeloma
“We are excited CFT7455 monotherapy is showing promising signs of anti-myeloma and immunomodulatory activity and anti-myeloma activity when combined with dexamethasone, particularly in patients who have undergone numerous lines of prior therapy for multiple myeloma, including BCMA therapies,” said Len Reyno, M.D., chief medical officer of C4 Therapeutics. “We have established 14 days on/14 days […]
Marker Therapeutics Announces Sustained Complete Response In First Lymphoma Patient Treated With MT-601 Following CAR-T Relapse
“Witnessing the sustained complete response in our first patient treated with MT-601 over six months has been an encouraging and rewarding experience,” commented Dr. Geoffrey Shouse, the Principal Investigator at City of Hope National Medical Center in Duarte California. “This is a remarkable achievement, demonstrating the potential impact of MT-601 in patients with lymphoma who […]
Topline Results from Phase 1 Dose Escalation Trial of BDTX-1535 in Patients with Recurrent GBM Announced
“These initial results in patients with recurrent GBM are encouraging, as there are no approved therapies available for those who progress following initial treatment, and there is strong rationale for a brain penetrant, covalent EGFR inhibitor such as BDTX-1535 to have a meaningful impact in earlier lines of therapy,” said Patrick Wen, M.D., Director of […]
FDA guides on the next Phase 2 study supporting the advancement of Next Generation Capecitabine (“NGC-Cap”) for cancer patients
“The FDA provided helpful guidance on the overall design of our NGC-Cap Phase 2 study for which we anticipate beginning enrollment in mid-2024. We believe that NGC-Cap may provide a better safety/efficacy profile than FDA-approved Capecitabine, eventually providing treatment for the tens of thousands of patients who cannot tolerate the existing Capecitabine,” said David Young, […]
