Jemperli (Dostarlimab-Gxly) RUBY Ph 3 Trial Met Its Primary Endpoint In A Planned Interim Analysis In Patients With Primary Advanced Or Recurrent Endometrial Cancer
Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK said: “Patients with primary advanced or recurrent endometrial cancer have limited treatment options. Long-term outcomes remain poor, and new treatment options are urgently needed to evolve the current standard of care, which is platinum-based chemotherapy. Based on these positive headline results from the RUBY […]
New Data from the OLYMPUS Trial Shows mDOR of 28.9 Months for JELMYTO for Adults with Low-Grade Upper Tract Urothelial Cancer
“The clinical benefit of JELMYTO was demonstrated in the Phase 3 OLYMPUS study and data presented today highlighted the long-term durability of that benefit,” said Dr. Phillip Pierorazio, M.D., Chief, Section of Urology at Penn Presbyterian Medical Center, Philadelphia, PA. “JELMYTO provides an effective and durable kidney-sparing treatment option and should be considered as primary […]
FDA Fast Track Designation to pelareorep + atezolizumab + chemotherapy for the Treatment of Advanced/Metastatic Pancreatic Cancer
“Receiving this Fast Track designation is an important accomplishment that speaks to the impressive response rate and the durability of the response in our PDAC study, and it also reflects the pressing need to improve upon the standard of care in this indication,” stated Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech […]
U.S. indication of Tecentriq® for the treatment of cisplatin-ineligible, PD-L1+ve adults with locally advanced or mUC to be withdrawn
“While we are disappointed with this withdrawal, we understand the need to uphold the principles of the FDA’s Accelerated Approval Program, which brings innovative medicines to patients sooner. We remain confident in the benefit Tecentriq offers to people diagnosed with some of the most difficult-to-treat forms of cancer,” said Levi Garraway, M.D., Ph.D., chief medical […]
FDA accepts BLA of Denileukin Diftitox for the Treatment of Patients with Persistent or Recurrent Cutaneous T-Cell Lymphoma
“The acceptance of the previously announced BLA submission for I/ONTAK is another important regulatory milestone for our oncology program. With an anticipated PDUFA date of September 28, 2023, we look forward to the potential approval of this therapeutic for patients with persistent or recurrent cutaneous T-cell lymphoma, a rare disease for which patients with advanced […]
FDA Granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track Designations to CB-010
“RMAT and Fast Track designations for CB-010 are important recognitions of the significant unmet patient need for an off-the-shelf cell therapy in the treatment of aggressive B-NHL,” said Rachel Haurwitz, Ph.D., Caribou’s president and chief executive officer. “Through genome editing with our precision CRISPR chRDNA genome-editing technology, CB-010 has been designed with a PD-1 knockout […]
FDA Approves REZLIDHIA™ (olutasidenib) for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with a Susceptible IDH1 Mutation
“REZLIDHIA is a novel, non-intensive monotherapy treatment in the relapsed/refractory AML setting demonstrating a CR+CRh rate of 35% in patients with over 90% of those responders in complete remission. The 25.9 months median duration of CR+CRh is a clinically meaningful improvement for AML patients and appears to be longer than currently available treatment options,” said […]
Lyvgen Announces Ph 2 Clinical Collaboration with Bristol Myers Squibb to Evaluate LVGN7409 in Combination with Nivolumab in NSCLC Patients
“Lyvgen clinical collaboration with Bristol Myers Squibb underscores our commitment to exploring combination regimens from our portfolio with complementary mechanisms of action that may transform cancer care”, said Jieyi Wang, Ph.D., Founder and CEO of Lyvgen. “We are excited to enter this clinical collaboration with Bristol Myers Squibb and look forward to initiating enrollment in […]
C4XD signs exclusive global licence worth up to $402 million with AstraZeneca for the development and commercialisation of NRF2 Activator programme
Sir Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca said: “At AstraZeneca, we are committed to transforming care in respiratory and immune-mediated disease and move beyond symptom control. Our alliance with C4XD adds an important new asset to our portfolio to push the boundaries of science by targeting underlying disease drivers to potentially modify the […]
FogPharma Announces $178 Million Series D Financing to Advance Pipeline of First-in-Class Helicon Polypeptide Therapeutics Targeting Major Cancer Drivers
“FogPharma continues to make rapid progress on our moonshot mission to achieve universal druggability – a world where no targets are off-limits to medicine,” said Gregory Verdine, Ph.D., founder, chairman and chief executive officer of FogPharma. “We believe that Helicon polypeptides, a compelling new therapeutic modality, represent the future of precision medicine. We are thrilled […]
First Patient Dosed in Ph 2 ‘IPAX-Linz’ Study of TLX101 for Glioblastoma Therapy
Prof. Josef Pichler, Kepler University Hospital, Austria, Principal Investigator in the IPAX-Linz study said, “Based on promising safety and early efficacy data for TLX101 in the IPAX-1 study, I am pleased to continue to explore this therapeutic modality in a larger patient cohort, where there are currently few effective treatment options. Preliminary results are only […]
Positive Update On Joint TIGIT Program From Interim Analysis Of ARC-7 Study In NSCLC Announced
“The efficacy measures observed, including PFS, reinforce confidence in the TIGIT pathway. The interim results show that combining two checkpoint inhibitors – an anti-TIGIT and an anti-PD-1 – delivered added benefit beyond anti-PD-1 monotherapy in this setting,” said Melissa L. Johnson, M.D., Director Lung Cancer Research, Sarah Cannon Research Institute at Tennessee Oncology, and Lead […]
ARV-471 Achieves a CBR of 38% in Evaluable Patients and Continues to Show a Favorable Tolerability Profile in its Ph 2 Expansion Trial (VERITAC)
“I’m gratified to see the continued differentiated profile of ARV-471 and its potential to become an important new standard of care for patients with ER+/HER2- breast cancer,” said John Houston, Ph.D., President and Chief Executive Officer at Arvinas. “The positive VERITAC results, in a heavily pre-treated population in which 100% of the patients received at […]
Ph 3 KEYNOTE-859 Trial Met Primary Endpoint of Overall Survival in Patients With HER2-Negative Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
“Despite improvements in cancer care, advanced gastric cancer continues to have one of the lowest five-year survival rates, and new interventions are urgently needed. The results from KEYNOTE-859 show the potential of KEYTRUDA plus chemotherapy to improve survival beyond chemotherapy alone for patients with HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, […]
U.S. FDA Accepts for Priority Review the BLA for Epcoritamab (DuoBody®-CD3xCD20) for the Treatment of R/R Large B-Cell Lymphoma
“We are committed to the research and development of innovative therapies to provide important treatment options for people living with blood cancer such as large B-cell lymphoma, which has limited treatment options in the relapsed/refractory setting,” said Mohamed Zaki, M.D., Ph.D., vice president and head, global oncology development, AbbVie. “This milestone signals an early step […]
FDA issued CRL indicating the poziotinib application cannot be approved in its present form; company to deprioritise the program
“While we are not surprised by the CRL given the ODAC recommendation in September, we are disappointed. After multiple interactions with the FDA since ODAC, and following careful consideration, we have made the strategic decision to immediately de-prioritize the poziotinib program,” said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. “We continue to […]
Update provided on Blenrep (belantamab mafodotin-blmf) US marketing authorisation
Sabine Luik, Chief Medical Officer, said, “We respect the Agency’s approach to the accelerated approval regulations and associated process. Multiple myeloma is a challenging disease, with poor outcomes for patients whose disease has become resistant to standard-of-care treatments. We will continue the DREAMM clinical trial programme and work with the US FDA on a path […]
FDA Clears IND Application for CB-011, an Allogeneic Anti-BCMA CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Multiple Myeloma
“Clearance of our second IND application represents another key milestone for our pipeline of promising allogeneic cell therapies designed to have enhanced persistence of antitumor activity,” said Rachel Haurwitz, Ph.D., Caribou’s president and chief executive officer. “CB-011 is designed with an immune cloaking strategy to reduce rejection of the cell therapy by a patient’s T […]
ENHERTU® Approved in Japan for Patients with Previously Treated HER2 Positive Metastatic Breast Cancer
“We are proud of the quality and speed in which we were able to deliver a confirmatory phase 3 trial that demonstrated the superiority of ENHERTU in prolonging progression-free survival compared to T-DM1 in patients with previously treated HER2 positive metastatic breast cancer,” said Wataru Takasaki, PhD, Executive Officer, Head of R&D Division in Japan, […]
Jnana Therapeutics Announces Second Collaboration with Roche to Address Challenging-to-Drug Targets in Cancer, Immune-Mediated and Neurological Diseases
“We are excited to partner with Roche, one of the largest healthcare companies and a strong collaborator, for a second time,” said Joanne Kotz, Ph.D., co-founder and CEO of Jnana Therapeutics. “Roche has been a valuable strategic partner and we are proud that our success to date has led to the opportunity to broaden our […]
Lantheus and POINT Biopharma Announce Strategic Collaboration and Exclusive License Agreements for the Commercialization of PNT2002 & PNT2003
“These exclusive license agreements and collaborations leverage the complementary strengths of both companies in radiopharmaceutical oncology and enhance the potential impact that these compelling therapeutic candidates could provide to patients,” said Mary Anne Heino, President and CEO of Lantheus. “Lantheus has extensive radioisotope supply chain and distribution experience, recognized leadership in radiopharmaceuticals and prostate cancer, […]
Positive Top-Line Results From Ph 3 Trial of DCVax®-L for Glioblastoma announced
Ms. Powers, CEO of NW Bio, commented: “We are excited to see the meaningful survival extensions in glioblastoma patients treated with DCVax®-L in this trial – particularly in the “long tail” of the survival curve, where we see more than double the survival rates as with existing standard of care. With well over 400 clinical […]
Ph 3 Trial of ICLUSIG® (ponatinib) Met Primary Endpoint in Newly-Diagnosed Ph+ ALL
“Ph+ ALL is a fast-progressing disease with no targeted treatments currently approved in the frontline for patients in the U.S. There is an urgent need for an effective treatment that can suppress the development of difficult-to-treat mutations, which are associated with poor long-term outcomes,” said Awny Farajallah, MD, Head of Global Medical Affairs Oncology at […]
INT230-6 +/- Ipilimumab Shows Evidence of Direct Tumor Necrosis and Promising OS Results in Adult Subjects with Metastatic Sarcomas
“Preliminary data suggests that INT230-6, as a monotherapy or in combination with the immune checkpoint blocker ipilimumab, demonstrates direct tumor killing in soft tissue sarcoma (STS) and elicits an anti-cancer immune response within the injected tumor,” stated Matthew Ingham, M.D., assistant professor of medicine in the Division of Hematology and Oncology, Columbia University Vagelos College […]
Topline Data from the Ph 2 MIRAGE Study of Zandelisib in Patients with Indolent B-cell NHL in Japan announced
“We are very pleased to announce the data from Phase 2 MIRAGE study,” said Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of R&D Division of Kyowa Kirin. “We continue to see a favorable profile of zandelisib with intermittent dosing that aims to balance efficacy and safety in Japanese patients who have been heavily pre-treated. […]
Positive Topline Result in Fruquintinib Ph 3 FRUTIGA Study in 2L Gastric Cancer in China announced
“The combination of fruquintinib and paclitaxel demonstrated significant clinical benefits for these patients in controlling this disease. Our team will continue to analyze the data and discuss these findings with the NMPA for possible NDA filing,” said Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED.
ATG-008 Efficacy Results From TORCH-2 Study in Combination with PD-1 Antibody in Relapsed/Metastatic Cervical Cancer
“The 52.4% ORR from the TORCH-2 study with ATG-008 and toripalimab in patients with relapsed/metastatic cervical cancer, coupled with a manageable safety profile, is an exciting result that provides a potential guide to a registration program for ATG-008. Antengene intends to review the data with the Chinese CDE and move forward into pivotal studies as […]
MARIO-3 Updated reported in Patients with 1L mTNBC Suggesting Potential Long-Term Patient Benefit of Eganelisib
“Given our goal of improving long-term patient outcomes, we are particularly pleased to see that the addition of eganelisib to standard of care therapy showed benefit in the one-year progression free survival rate in MARIO-3 regardless of PD-L1 status,” said Robert Ilaria, Jr., MD, Chief Medical Officer of Infinity. “These data reinforce the positive two-year […]
100% Clinical Response in Cervical Cancer Patients in Preliminary Data from IMMUNOCERV Ph 2 Clinical Trial announced
“The updated data from the ongoing IMMUNOCERV Phase 2 clinical trial presented during SITC 2022 add to the encouraging results observed thus far and suggest that the combination of PDS0101 and CRT may hold promise as a potential first-line treatment for advanced, localized cervical cancer,” said Dr. Frank Bedu-Addo, CEO of PDS Biotech. “Importantly, 100% […]
New Ph 2 Data with CG0070 in Combination with KEYTRUDA® in NMIBC Unresponsive to BCG announced
“We’re excited to present these results, which continue to support CG0070’s promise in patients with bladder cancer unresponsive to BCG, a difficult-to-treat patient population,” said Arthur Kuan, Chief Executive Officer, CG Oncology. “We are seeing continued positive results for CG0070 in combination with pembrolizumab in NMIBC patients unresponsive to BCG. Enrollment in this study is […]
