mRNA-4157/V940 + KEYTRUDA® combo Granted Breakthrough Therapy Designation by the FDA for Adjuvant Treatment of Patients With High-Risk Melanoma Following Complete Resection
“The FDA’s Breakthrough Designation for mRNA-4157/V940 in combination with KEYTRUDA reflects the excitement that we have for the potential promise of individualized cancer treatments,” said Stephen Hoge, M.D., Moderna’s President. “mRNA-4157/V940 in combination with KEYTRUDA provided the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial and potentially represents […]
Imfinzi plus Imjudo approved in the EU for patients with 1L HCC and mNSCLC based on significant survival benefits in HIMALAYA and POSEIDON Ph 3 trials
Bruno Sangro, MD, PhD, Director of the Liver Unit and Professor of Internal Medicine at Clínica Universidad de Navarra, and a lead investigator in the HIMALAYA Phase III trial, said: “This approval in Europe is welcome news for eligible patients with advanced liver cancer, who face a poor prognosis and are in need of well-tolerated […]
NMPA grants Tislelizumab + chemo approval for 1L use in advanced gastric or gastroesophageal junction adenocarcinoma with high PD-L1 expression
“Advanced gastric cancer remains a significant cause of cancer-related mortality in China and we are pleased that tislelizumab plus chemotherapy demonstrated a meaningful survival benefit for patients whose tumors express PD-L1 in the RATIONALE 305 study,” said Lai Wang, Ph.D., Global Head of R&D at BeiGene. “We are grateful to the patients, investigators, and experts […]
Fusion Pharmaceuticals To Acquire Ph 2 Program For 225Ac-PSMA I&T, A Radiopharmaceutical Targeting mCRPC
“We are pleased to announce this acquisition, which adds an ongoing Phase 2 program for a validated cancer target to our pipeline of innovative TATs,” commented Fusion Chief Executive Officer John Valliant, Ph.D. “From our inception, Fusion has recognized the potential opportunity for actinium-based therapies to address unmet needs in cancer given the power and […]
Cullinan Oncology enters into an exclusive license with Harbour BioMed for the development and commercial rights of HBM7008 (CLN-418) in the U.S.
“We are pleased to bring CLN-418, a potential first-in-class, clinical-stage bispecific immune activator, into our diversified portfolio. We believe the best approach to conditional activation of 4-1BB is by targeting B7H4, a tumor associated antigen that is highly expressed across multiple cancers and minimally overlaps with PD-L1 expression. CLN-418 is a strong strategic fit for […]
Wellmarker Bio Announces Clinical Trial Collaboration with MSD to evaluate WM-A1-3389 in combination with KEYTRUDA
“Under the agreement, WMBIO will sponsor the Phase 1 (or Phase 1b) clinical trial for WM-A1-3389, a novel therapeutic antibody for Non-Small Cell Lung Cancer (NSCLC) patients with low or no PD-L1 expression, in combination with KEYTRUDA® (pembrolizumab), MSD’s anti-PD-1 therapy. Some NSCLC patients with low or no PD-L1 expression have shown limited response to […]
Nectin Therapeutics and Merck to test Anti-PVR Antibody NTX1088 + KEYTRUDA® in Patients with Locally Advanced and Metastatic Solid Tumors
“We are very pleased to partner with Merck to explore the therapeutic potential of NTX1088 in combination with KEYTRUDA®. This collaboration represents an important milestone for Nectin, and a promising new therapy for cancer patients,” said Dr. Keren Paz, Chief Development Officer of Nectin Therapeutics. “Our preclinical studies have shown that PVR blockade by NTX1088, […]
Trilaciclib Ph 3 PRESERVE 1 trial in CRC patients to discontinue after absence of efficacy signals in early data
“PRESERVE 1 is the first clinical evaluation of trilaciclib in a 5-FU-based chemotherapeutic backbone,” said Raj Malik, M.D., G1 Therapeutics’ Chief Medical Officer. “This study reaffirms that trilaciclib is a highly effective drug for myeloprotection that all but eliminated neutropenia as a concern for patients with CRC in the trial, which helps inform our ongoing […]
Ph 3 Study of Uproleselan in R/R AML to continue to Originally Planned Final Analysis Following Interim Analysis by Independent Data Monitoring Committee
“We thank the independent DMC for its recommendation and are strongly encouraged as the blinded pooled survival data continues to show patients living longer than historical benchmarks. Going forward, survival duration for new events in the study will be greater than 14 months since the last patient was randomized, giving us confidence in the potential […]
First Patients Dosed in Ph 2 Registrational Trial of Ziftomenib in NPM1-Mutant AML
“Dosing the first patients in our registration-directed trial of ziftomenib marks a significant milestone for our menin inhibitor program,” said Troy Wilson, Ph.D., J.D., President & Chief Executive Officer of Kura Oncology. “Building on the strength of our Phase 1 data, we remain committed to our mission to realize the full potential of ziftomenib as […]
Ph 2 Randomized Trial for ATR Inhibitor ART0380 plus Gemcitabine in Patients with Platinum Resistant Ovarian Cancer initiated
Dr. Niall Martin, Chief Executive Officer at Artios, said: “This is the first of three proof of concept Phase 2 studies planned to evaluate our potentially best-in-class ATR inhibitor, ART0380, that has demonstrated a favorable safety and tolerability profile and clinical activity in the Phase 1 dose escalation. We are delighted to be collaborating with […]
Positive Final OS Results of Ph 3 JUPITER-02 Trial of Toripalimab as Treatment for Recurrent or mNPC announced
“In the pivotal JUPITER-02 trial, toripalimab has demonstrated a statistically significant and clinically meaningful overall survival benefit for patients with advanced NPC, an aggressive head and neck tumor with no current FDA-approved treatment options,” said Rosh Dias, M.D., Coherus’ Chief Medical Officer. “These mature overall survival data continue to demonstrate the benefit of toripalimab in […]
Trodelvy® Demonstrates Positive Efficacy Treating Both Platinum-Ineligible And Rapidly Progressing, Post-Platinum Metastatic Urothelial Cancer
“The TROPHY-U-01 data show consistent benefit of Trodelvy across multiple types of metastatic urothelial cancer, including the most difficult-to-treat and, often times, frail patients where treatment options are still scarce,” said Bill Grossman, MD, PhD, Senior Vice President, Therapeutic Area Head, Gilead Oncology. “Trodelvy has the potential to become a cornerstone treatment in metastatic urothelial […]
Clinical Responses from the Ph 2 OATH Clinical Trial Evaluating ONA-XR for the Treatment of Endometrial Cancer highlighted
“Data from the ongoing Phase 2 OATH clinical trial supports the potential for ONA-XR plus ANA combination therapy to serve as an effective therapeutic option in metastatic EC. We are encouraged by these findings and look forward to continued enrollment in the trial,” said Martin Lehr, CEO of Context Therapeutics.
Tecartus® CAR T-Cell Therapy Demonstrates OS Benefit In 3-Year Follow-Up Of Pivotal ZUMA-3 Trial In R/R B-Cell Acute Lymphoblastic Leukemia
“For adult patients living with ALL, there is a need for therapeutic options that provide long-term responses,” said Bijal Shah, MD, ZUMA-3 investigator and medical oncologist, Moffitt Cancer Center, Tampa, Florida. “The continued durable response and significant improvement in survival indicated by these new data can potentially establish a new standard of care for adult […]
FDA grants Fast Track designation for KIN-3248 for the treatment of patients with metastatic cholangiocarcinoma
“U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Kinnate’s investigational pan-FGFR inhibitor, KIN-3248, for the treatment of patients with unresectable, locally advanced or metastatic cholangiocarcinoma (CCA) harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other alterations, who have received at least one prior systemic therapy.”
Regulatory update provided on the clinical development plan of Tedopi® in Ph 3 in monotherapy in advanced or mNSCLC after checkpoint inhibitor failure
Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: “We are pleased with the positive outcomes from the US Food & Drug Administration (FDA) Type C Meeting following the supportive European Medicines Agency (EMA) advice, as we are actively preparing a confirmatory phase 3 trial to support the regulatory registration of Tedopi®. Leveraging on the […]
US FDA grants regular approval for Jemperli for the treatment of patients with recurrent or advanced mismatch repair-deficient endometrial cancer
Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK, said: “This US regulatory action confirms our confidence in Jemperli as an important treatment option for patients with dMMR recurrent or advanced endometrial cancer. We continue to unlock the potential of Jemperli as the backbone for our immuno-oncology development programmes to address the unmet […]
Kite And Arcellx Close Agreement To Co-Develop And Co-Commercialize Late-Stage Clinical CART-DdBCMA In Multiple Myeloma
Currently being investigated in a Phase 2 pivotal trial, CART-ddBCMA is Arcellx’s T-cell therapy utilizing the company’s novel synthetic binder, the D-Domain. Kite and Arcellx will jointly advance and commercialize the CART-ddBCMA asset in the U.S., and Kite will commercialize the product outside the U.S.
CARsgen Announces Collaboration Agreement to Evaluate AB011 in Combination with Atezolizumab to Treat Gastric Cancer
“We are glad to work with Roche, a global leader in oncology, to explore the potential of AB011 in combination with atezolizumab and chemotherapy for the treatment of gastric cancer,” said Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen, “Gastric cancer is one of the most […]
TROPION-Lung07 Ph 3 Trial Initiated to Evaluate Datopotamab Deruxtecan in Combination with Pembrolizumab in 1L mNSCLC Patients
“Metastatic non-squamous non-small cell lung cancer remains a challenge because the majority of patients experience disease progression following their initial treatment, underscoring the need for more effective treatment optionsin the first-line setting,” said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo. “The TROPION-Lung07 trial will assess the potential of the combination of datopotamab […]
First Patient Dosed in NMIBC Substudy of the LUMINOS-103 Basket Trial Evaluating Lerapolturev Monotherapy
“We know that NMIBC tissue expresses the poliovirus receptor, CD155 and is responsive to immunotherapy, providing the rationale for intravesicular lerapolturev for patients with low to intermediate risk BCG-naïve NMIBC,” said W. Garrett Nichols, MD, MS, Chief Medical Officer at Istari Oncology. “Approximately 60,000 patients with low to intermediate risk NIMBC are identified each year […]
NRG-GY018 Study Demonstrates Significantly Improved PFS Outcomes for Women with Endometrial Cancer with the Addition of Pembrolizumab to Chemotherapy
“Patients with advanced stage or recurrent endometrial cancer, the most common type of gynecologic cancer in the U.S., face a poor prognosis with limited treatment options. This is particularly notable in patients who progress after prior platinum-based adjuvant therapy with disease not amenable to curative surgery or radiation,” stated Ramez Eskander, MD, of the University […]
KEYTRUDA + Chemo Met Primary Endpoint of PFS as First-Line Therapy for Advanced or Recurrent Endometrial Carcinoma
“Patients with advanced stage or recurrent endometrial cancer, the most common type of gynecologic cancer in the U.S., face a poor prognosis with limited treatment options. This is particularly notable in patients who progress after prior platinum-based adjuvant therapy with disease not amenable to curative surgery or radiation,” said Dr. Ramez Eskander, principal investigator and […]
FDA Orphan Drug Designation for ezurpimtrostat to treat HCC
“FDA Orphan Drug Designation is a significant milestone for both Genoscience and for our product, ezurpimtrostat. It recognizes that our treatment has the potential to improve the lives of individuals living with HCC,” said Professor Philippe Halfon, CEO of Genoscience Pharma. “We have recently launched our phase 2b clinical trial using ezurpimtrostat in conjunction with […]
FDA Approval of IND Application for EP0042 for AML Patients Announced
Dr Rajan Jethwa, Chief Executive Officer & Founder of Ellipses, commented “This FDA approval of EP0042’s Investigational New Drug application allows us to open additional trial sites in the world’s foremost pharmaceutical market. This will help us in achieving our strategic goal of bringing potential new treatment options to patients in need at unprecedented speed, […]
FDA Approves Jaypirca™ (pirtobrutinib) for Adult Patients with R/R Mantle Cell Lymphoma After at Least Two Lines of Systemic Therapy, Including a BTK Inhibitor
“The approval of Jaypirca represents an important advance for patients with relapsed or refractory MCL, who currently have limited options and historically have had a poor prognosis following discontinuation of treatment with a covalent BTK inhibitor,” said Michael Wang, M.D., Puddin Clarke Endowed Professor of Lymphoma and Myeloma at The University of Texas MD Anderson […]
U.S. FDA Approves Trodelvy In Pre-Treated HR+/HER2- Metastatic Breast Cancer
“Despite decades of advances, people living with pre-treated HR+/HER2- metastatic breast cancer need new treatment options. Nearly all people with this type of breast cancer will eventually develop resistance to endocrine-based therapies and progress on available chemotherapies,” said Hope S. Rugo, MD, Professor of Medicine and Director, Breast Oncology and Clinical Trials Education at the […]
Teon Therapeutics Announces Clinical Trial Collaboration With Merck to Evaluate TT-81 in Combination with KEYTRUDA
“We are fortunate to have the opportunity to collaborate with Merck for this Phase 1/2 trial. The collaboration of the combination arm of our TT-816 clinical trial represents an important advancement in our comprehensive development program and further supports our mission to invent new hope for patients by potentially providing meaningful treatments to those with […]
Takeda To Acquire Exclusive Worldwide (ex-China) License of HUTCHMED’s Fruquintinib
“Fruquintinib has the potential to change the treatment landscape for patients with refractory metastatic CRC who are in need of additional treatment options. We look forward to utilizing our development and commercial capabilities to expand the potential of this innovative medicine to patients beyond China,” said Teresa Bitetti, President of the Global Oncology Business Unit […]
