Positive Topline Results Announced from Final PFS Analysis of BRUKINSA® (zanubrutinib) vs IMBRUVICA® (ibrutinib) in Ph 3 ALPINE trial in CLL patients
“This positive result adds to the growing body of evidence underpinning our belief in the potential for BRUKINSA to provide new hope for CLL patients facing this intractable disease. With this final PFS analysis, BRUKINSA has achieved superior progression free survival, as well as superiority in overall response rate versus ibrutinib,” said Mehrdad Mobasher, M.D., […]
U.S. FDA Accepts For Priority Review The sBLA For Trodelvy® For Pre-Treated HR+/HER2- Metastatic Breast Cancer
“Trodelvy has already changed the treatment landscape in second-line metastatic triple-negative breast cancer and pre-treated metastatic urothelial cancer, and today’s news marks our third supplemental application acceptance within the last two years,” said Bill Grossman, MD, PhD, Senior Vice President, Therapeutic Area Head, Gilead Oncology. “People with pre-treated HR+/HER2- metastatic breast cancer who have progressed […]
US FDA grants Fast Track Designation for SHP2 inhibitor BBP-398 in Combination with LUMAKRAS® (sotorasib)
“The survival rate following a diagnosis of NSCLC with a KRAS mutation is extremely poor. We are hopeful that by launching this clinical trial with Amgen, we may be able to fill the current gap in unmet medical need for these cancer patients,” said Frank McCormick, Ph.D., chairman of oncology at BridgeBio. “We are grateful […]
Positive Pre-NDA Meeting for Rivoceranib Combination With Camrelizumab as Hepatocellular Carcinoma Treatment Option Announced
“Our team at Elevar is very pleased with the results of our pre-NDA meeting with respect to rivoceranib plus camrelizumab as a treatment option for HCC, continuing a collaborative process with the FDA that allows us to maintain our timeline for the upcoming rivoceranib FDA filings in two indications with clearly demonstrated unmet medical need,” […]
Exelixis Expands Clinical Trial Collaboration and Supply Agreement with Bristol Myers Squibb to Include the Fixed-Dose Combination of Nivolumab and Relatlimab in Combination with XL092 in Ph 1b STELLAR-002 Trial
“We are pleased to expand our agreement with Bristol Myers Squibb for the STELLAR-002 trial to include the novel fixed-dose combination of nivolumab and relatlimab to evaluate the potential benefit of combining XL092 with additional immune checkpoint inhibitors,” said Vicki L. Goodman, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, […]
Autolus Therapeutics Announces Collaboration with Bristol Myers Squibb for Use of Autolus’ Proprietary Safety Switch System
“Safety switches are critical to the future of our field of advanced cell therapies. They allow us to develop approaches that are designed to significantly improve patient outcomes, whilst at the same time incorporating the potential to reduce the risk of severe adverse side effects from the treatment,” said Dr. Martin Pule, CSO of Autolus. […]
Kite Receives U.S. FDA Approval Of Viral Vector Manufacturing Facility In Southern California To Produce Commercial Product
“The FDA approval of our commercial viral vector manufacturing facility further strengthens our global cell therapy manufacturing network with the addition of an in-house capability to produce a crucial element in the CAR T process, which is especially important as patient demand continues to grow,” said Christi Shaw, Chief Executive Officer of Kite. “This milestone […]
Ph 2 Clinical Trial of DNA-Damaging Agent PLX038 initiated in patients with Platinum-Resistant Ovarian Cancer
Drs. Hendrickson and Kaufmann stated, “We are excited to be able to bring this novel treatment to patients with relapsed, platinum-resistant ovarian cancer, in hopes of improving the outcome of this disease.” Added ProLynx co-founder and President Daniel V. Santi “Conventional short-acting topoisomerase 1 inhibitors have clinical activity in platinum-resistant ovarian cancer. Accordingly, we are […]
First Allogeneic CAR T Ph 2 ALPHA2 Trial of ALLO-501A in Relapsed/Refractory Large B Cell Lymphoma Patients initiated
“We are proud to initiate the industry’s first potentially pivotal Phase 2 trial for an allogeneic CAR T product. This milestone paves the road for both ALLO-501A and our broader pipeline of innovative products with the potential to greatly increase patient access to cell therapy,” said David Chang, M.D., Ph.D., President, Chief Executive Officer and […]
Ph 1/2 Trial of ABC008 initiated in Patients with T Cell Large Granular Lymphocytic Leukemia
“Initiating the Phase 1/2 clinical trial of ABC008 represents an important step toward a potential breakthrough in the treatment of T-LGLL,” said Jeffrey Wilkins, MD, Chief Medical Officer of Abcuro. “This trial builds upon prior published data demonstrating the ability of ABC008 to deplete highly cytotoxic T cells, which attack and destroy muscle tissue in […]
First Patient Treated in Ph 1/2 Clinical Trial of MB-106 in B-cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
Manuel Litchman, M.D., President and Chief Executive Officer of Mustang said, “The first clinical trial under Mustang’s IND is an important milestone in the ongoing development and evaluation of MB-106. Data presented at several prestigious medical meetings earlier this year from the initial, ongoing Phase 1/2 clinical trial at Fred Hutch show that MB-106 continues […]
Part 3 of the CORIST Ph 2 trial of SCO-101 as a combination treatment in patients with metastatic colorectal cancer (mCRC) initiated
“We are pleased to initiate part 3 of CORIST in accordance with our plans and communicated timeline. SCO-101 has potential to improve treatment options in mCRC and we are excited to continue the work to best harness this potential to the benefits of patients, health care professionals and Scandion”, says Johnny Stilou, acting Chief Executive […]
TRITON3 Ph 3 Trial Of Rubraca® (Rucaparib) Achieves Primary Endpoint In Men With mCRPC With BRCA Or ATM Mutations
“We believe that the positive results from TRITON3 further demonstrate the important role that Rubraca can play as a treatment option for men with metastatic castration-resistant prostate cancer associated with homologous recombination deficiency, and we look forward to submitting these data to the regulatory authorities in the US during Q1 2023. Not only does this […]
Ph 3 TALAPRO-2 study of TALZENNA® + XTANDI® in mCRPC patients met its primary endpoint of rPFS compared with placebo plus XTANDI
“XTANDI is a global standard of care, with overall survival demonstrated in mCRPC, non-metastatic CRPC, and metastatic castration-sensitive prostate cancer (mCSPC),” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development. “We are very pleased with the strong findings from TALAPRO-2, and although no definitive conclusions can be made […]
PERLA Ph 2 trial Of Jemperli (Dostarlimab) + Chemotherapy In Patients With mNSCLC met the primary endpoint of ORR
Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK said: “These trials support the ambition for dostarlimab to become the backbone of our ongoing immuno-oncology-based research and development programme when used alone and in combination with standard of care and future novel cancer therapies, particularly in patients with currently limited treatment options.”
Results Of Independent Data Monitoring Committee Review Of 12 Week Safety Data From ENVASARC Ph 2 Pivotal Trial announced – Trial To Proceed As Planned
“Envafolimab at the 600 mg dose has been well tolerated as a single agent and when combined with Yervoy in refractory sarcoma patients who are enrolled in the ENVASARC trial. Accrual continues to exceed projections and we remain on track for the Independent Data Monitoring Committee to review interim efficacy data in the fourth quarter […]
FDA grants Fast Track Designation for LAG-3 Therapeutic Eftilagimod Alpha for 1L NSCLC
“We are pleased to receive this Fast Track designation as it acknowledges efti’s unique potential to empower the human immune system against cancer and significantly enhance patient responses to standard-of-care immunotherapy. Efti also offers a chemotherapy-free option for NSCLC patients in need of less toxic and more durable solutions,” stated Marc Voigt, CEO of Immutep.
FDA grants Fast Track Designation for Sapanisertib for the Treatment of NRF2-mutated Squamous Lung Cancer
“While there have been significant advances in targeted treatments for lung cancer, little progress has been made specifically for patients with squamous lung cancer. In addition, we know that patients with lung cancers that harbor mutations in the NRF2/KEAP1 pathway typically have poorer outcomes than those whose tumors do not have these mutations,” said Susan […]
RAMP VS-6766 Clinical Trials Updates Announced
“We are pleased with the encouraging results to date from our RAMP 201 trial in patients with recurrent low-grade serous ovarian cancer as we continue to see independently confirmed response rates, no new safety signals and a majority of patients still on treatment,” said Brian Stuglik, Chief Executive Officer of Verastem Oncology. “As part of […]
FDA Clearance granted to Begin SVV-001 Ph 1/2 Clinical Study
FDA clearance granted to begin a Phase I/II clinical study utilizing Seneca Valley Virus (“SVV-001”) in combination with a checkpoint inhibitor. This Phase I/II study with SVV-001 is in patients that are TEM8 positive and SVV-001 permissive with neuroendocrine tumors or neuroendocrine carcinomas. The study should begin enrollment early in 2023.
THE-349 to be developed as EGFR inhibitor program in NSCLC
“We are delighted to announce THE-349 as the Company’s second development candidate and we look forward to evaluating its potential in patients with EGFR-mutant NSCLC,” said William Shakespeare, Ph.D., President of Research and Development at Theseus. “Clonal heterogeneity in patients who develop resistance to osimertinib is complex, and we believe a single EGFR inhibitor capable […]
Successful End-of-Phase 2 Meeting With the FDA and Preparation for the Registrational Trial of PDS0101 in Combination With KEYTRUDA®
“We are very pleased with the guidance received from FDA on key elements of the clinical program that will support the submission of a Biologics License Application (BLA) for our lead asset PDS0101,” said Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. “The interim safety and efficacy data we presented to the FDA has […]
IND Clearance for ONCT-808, autologous CAR T Product Candidate Targeting ROR1, for the Treatment of Aggressive B Cell Lymphoma
“We are very pleased with the clearance of our IND application for our lead autologous CAR T product candidate, ONCT-808,” said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. “This will be our second clinical program focusing on the important ROR1 cancer target, following the initiation of our phase 3 study for our ROR1 antibody […]
FDA approves first companion diagnostic to identify patients with HER2 low metastatic breast cancer eligible for ENHERTU
“Roche is proud to lead the way in HER2 diagnostics through critical innovations that support the identification of patients who may benefit from novel HER2-targeted therapies,” said Thomas Schinecker, CEO of Roche Diagnostics. “Previously, metastatic breast cancer patients with a lower level of HER2 expression were considered to be part of the HER2-negative population and […]
FDA Approves Futibatinib For FGFR2+ Advanced Cholangiocarcinoma
“LYTGOBI is an effective, well-tolerated therapy for patients with intrahepatic CCA that can be taken orally,” said Tim Whitten, President and CEO of Taiho Oncology, Inc. “This approval is an important milestone for patients and may provide hope for improved outcomes. As someone whose family has been impacted by cholangiocarcinoma, I’m acutely aware of the […]
TILT Biotherapeutics Collaborates with MSD on Immunotherapy Clinical Trial in Checkpoint Inhibitor Refractory NSCLC
TILT Biotherapeutics’ CEO, Akseli Hemminki, a cancer clinician who has personally treated hundreds of cancer patients, said, “We already have clinical trials running in Europe and the USA in several cancer types, including ovarian cancer, head and neck cancer, and melanoma. We are planning several more, one of which is this new collaboration in NSCLC […]
Seagen & LAVA Therapeutics Announce Exclusive Worldwide License Agreement to Advance LAVA-1223, a Gamma Delta BiTE for EGFR-Expressing Solid Tumors
“Seagen is committed to driving innovation to improve the lives of people with cancer, and this agreement represents the company’s entry into a novel class of therapeutics that are designed to overcome the challenges of standard T cell engagers by leveraging the activity of a distinct T cell subset,” said Roger Dansey, M.D., interim CEO […]
New Long-Term Data from L-MIND Suggesting Durable Response to Treatment with Monjuvi® (tafasitamab-cxix) for Patients with R/R DLBCL
“The body of data presented at SOHO shows the long-term duration of response to tafasitamab in some patients with relapsed or refractory diffuse large B-cell lymphoma not eligible for autologous stem-cell transplant,” said Malte Peters, M.D., MorphoSys Chief Research and Development Officer. “These long-term follow-up results for L-MIND reaffirm our belief that tafasitamab plus lenalidomide […]
CAR T-Cell Therapy Targeting GPRC5D Antigen Proves Effective in First Trial in Patients with Resistant Multiple Myeloma
“CAR T-cell therapies targeting BCMA [the B cell maturation antigen] – a protein prevalent on immune system B cells – have shown promise in advanced myeloma, but many patients relapse,” says Eric L. Smith, MD, PhD, of Dana-Farber, the co-senior author of the study with Renier Brentjens, MD, PhD, of Roswell Park Comprehensive Cancer Center. […]
Gavo-cel Continues to Demonstrate Clinical Benefit in Solid Tumors with Additional RECIST Responses in Ovarian Cancer and Mesothelioma
“The results of the Phase 1 trial underscore the potential clinical value of gavo-cel in a very heavily pretreated patient population that are receiving our engineered T cells as their sixth line of therapy on average,” said Alfonso Quintás-Cardama, M.D., Chief Medical Officer of TCR2 Therapeutics. “gavo-cel has demonstrated a manageable safety profile at the […]
