Orphan Drug Designation Granted to PTX-252 by U.S. FDA for the Treatment of Acute Myeloid Leukaemia (AML)
Stijn Van Rompay, Chief Executive Officer of Hyloris, commented: “Securing orphan drug designation for a product candidate incorporating a novel molecular entity, not yet approved by any regulatory agency, underscores our unwavering commitment to advancing the frontiers of scientific discovery within the repurposing space.”
European Commission approves Tecentriq SC, the EU’s first PD-(L)1 cancer immunotherapy subcutaneous injection for multiple cancer types
“We are pleased to introduce the first subcutaneous PD-L1 cancer immunotherapy in Europe,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Giving Tecentriq subcutaneously provides more flexibility to patients, while also helping to free up resources in constrained healthcare systems.”
Boehringer Ingelheim and 3T Biosciences signed a second T-cell focused collaboration
“At Boehringer Ingelheim, we are committed to transforming patients’ lives. The initial success of our work with 3T gives us confidence that together we can and will expand and accelerate our pipeline of first-in-class T-cell based anti-cancer therapies,” said Lamine Mbow, Ph.D., Global Head of Cancer Immunology and Immune Modulation, Boehringer Ingelheim.
AbbVie and Umoja Biopharma Announce Strategic Collaboration to Develop Novel In-Situ CAR-T Cell Therapies
“As we continue to strengthen our oncology portfolio, we believe that in-situ CAR-T cell therapy represents a paradigm shift utilizing genetic medicine concepts,” said Jonathon Sedgwick, Ph.D., vice president and global head of discovery research at AbbVie. “We look forward to working with Umoja’s team to advance next-generation in-situ CAR-T therapies, and potentially expand the […]
Last Patient Enrolled in Phase 3 TRIDENT Trial in Newly Diagnosed Glioblastoma
“TTFields therapy has played a critical role in the treatment of newly diagnosed glioblastoma for nearly a decade, and the TRIDENT trial represents the potential evolution of this treatment paradigm by introducing TTFields earlier, at the same time as radiation therapy and temozolomide,” said Asaf Danziger, Novocure’s Chief Executive Officer. “Preclinical research has shown that […]
Enrollment opens for Phase 1b/2 Study Evaluating Ampligen® (rintatolimod) in Combination with Imfinzi® (durvalumab) for the Treatment of Pancreatic Cancer
Prof. Casper H.J. van Eijck, MD, PhD, the DURIPANC Study’s Coordinating Investigator and a pancreato-biliary surgeon at Erasmus MC, stated, “While immune checkpoint inhibitors targeting PD1/PDL1 have shown promise in other solid tumors, they have shown limited efficacy thus far in ductal cancer of the pancreas. Findings from our previous study collectively provide compelling evidence […]
Clinical Response Update on AFM24-102 Trial in EGFR-wildtype Non-Small Cell Lung Cancer Provided
“We are encouraged by the responses in these patients who had all progressed on PD1 targeting therapy and made the strategic decision to expand this patient cohort,” said Dr. Andreas Harstrick, CMO and interim Chief Executive Officer of Affimed. “There is a significant unmet need for these patients who have exhausted all previous lines of […]
TIVDAK® sBLA Accepted for Priority Review by FDA for Patients with Recurrent or Metastatic Cervical Cancer
“The Phase 3 innovaTV 301 trial demonstrated a favorable benefit/risk profile, including improvement in overall survival, and adds to the overall data supporting TIVDAK as a treatment option for people with recurrent and metastatic cervical cancer who have limited treatment options,” said Roger Dansey, M.D., Chief Development Officer, Oncology at Pfizer. “The FDA acceptance of […]
Update on Zolbetuximab Biologics License Application in U.S.: FDA rejects the application
Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Senior Vice President and Head of Immuno-Oncology Development, Astellas said, “We remain confident in zolbetuximab’s clinical profile and potential to fill a significant therapeutic gap for those diagnosed with advanced gastric or GEJ cancer whose tumors are CLDN18.2 positive. Astellas is committed to working with the FDA and the third-party manufacturer […]
FDA Approves KEYTRUDA® (pembrolizumab) Plus Chemoradiotherapy as Treatment for Patients With FIGO 2014 Stage III-IVA Cervical Cancer
“Today’s approval of KEYTRUDA plus chemoradiotherapy is welcome news and gives patients with newly diagnosed FIGO 2014 Stage III-IVA cervical cancer, for the first time ever, the option of an anti-PD-1-based regimen to treat their cancer,” said Dr. Bradley Monk, oncologist and professor of obstetrics and gynecology at University of Arizona’s College of Medicine and […]
Boehringer Ingelheim And 3T Biosciences Enter Into A Second Partnership To Develop Next-Generation Cancer Immunotherapies
“At Boehringer Ingelheim, we are committed to transforming patients’ lives. The initial success of our work with 3T gives us confidence that together we can and will expand and accelerate our pipeline of first-in-class T-cell based anti-cancer therapies,” said Lamine Mbow, Ph.D., Global Head of Cancer Immunology and Immune Modulation, Boehringer Ingelheim.
Orion and MSD Announce Initiation of Two Phase 3 Trials Evaluating ODM-208/MK5684 in Certain Patients with Metastatic Castration-Resistant Prostate Cancer
“The start of our co-development Phase 3 program with MSD provides exciting opportunities to evaluate the potential of ODM-208/MK5684 as a novel treatment of mCRPC, both in front-line and late-line patients, including those with and without androgen receptor ligand binding domain (AR LBD) mutations,” said Professor Outi Vaarala, Senior Vice President, Innovative Medicines and Research […]
Global Phase 3 studies started for bomedemstat (LSD1 inhibitor), nemtabrutinib (BTK inhibitor), MK-2870 (anti-TROP2 ADC) and MK-5684 (CYP11A1 inhibitor)
“These Phase 3 trial initiations for four of our investigational candidates represent a critical step forward in our efforts to advance potential treatment options for people with solid tumors and hematologic neoplasms and malignancies,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “We have a proud […]
Patients enrolled into the Third Dosing Cohort of Phase 1/2 Study of ONCT-534 for the Treatment of R/R Metastatic Castration-Resistant Prostate Cancer
“The ONCT-534-101 investigators are enthusiastic about this study, and we are excited about the enrollment and progress through the initial dosing levels. Reaching the third cohort represents an important milestone for the program, as we believe we are nearing potentially therapeutic doses that may benefit prostate cancer patients who have progressed after treatment with approved […]
Positive Topline Data Achieving Primary Endpoint in Pivotal Clinical Study of Iopofosine I 131 in Waldenstrom’s Macroglobulinemia Announced
“There is a critical need for new therapies with novel mechanisms of action to treat WM. There are no approved treatments for patients post BTKi therapy, where currently the expected response rate to salvage treatments is approximately 10%, and the expected duration of response in those patients is less than six months,” said Sikander Ailawadhi, […]
Scemblix Shows Superior MMR Rates Vs. SoC TKIs In Phase III Trial For Newly Diagnosed Patients With CML
“We are very encouraged by these results given that a significant proportion of patients with newly diagnosed chronic myeloid leukemia, or CML, do not achieve their treatment goals,” said Prof. Tim Hughes, MD, South Australian Health & Medical Research Institute (SAHMRI). “There remains a significant need in first-line therapy of CML for tolerable treatment options, […]
FDA Issued New Postmarketing Requirement on sNDA seeking full approval of LUMAKRAS® (sotorasib)
“FDA has completed its review of the company’s supplemental New Drug Application seeking full approval of LUMAKRAS® (sotorasib). This review, which resulted in a Complete Response Letter, was based on the CodeBreaK 200 trial results for the treatment of adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC). The […]
FDA Clearance of Investigational New Drug Application for SC262 for Patients with Relapsed or Refractory B-cell Malignancies
“Patients who have failed a CD19-directed CAR T therapy represent a significant unmet need, and this population is growing as more patients receive these therapies,” said Doug Williams, PhD, Sana’s President of Research and Development. “SC262 represents an important potential option for these patients and is the next step in building Sana’s hypoimmune CAR T […]
Jemperli (dostarlimab) + Zejula (niraparib) combination significantly improved PFS in primary advanced or recurrent endometrial cancer in RUBY Part 2 Phase III trial
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “Patients with MMRp/MSS primary advanced or recurrent endometrial cancer have few approved treatment options. Today’s positive topline results reinforce our approach of building combination therapies with dostarlimab as the backbone in an effort to improve patient outcomes and options.”
FAILED TRIAL: CARMEN-LC03 trial did not meet dual primary endpoint of improving progression-free survival; tusamitamab ravtansine clinical development program will be discontinued
Dietmar Berger, Chief Medical Officer and Head of Development, said, “Our team is grateful to the patients, families and healthcare professionals involved in the tusamitamab ravtansine development program. Although the results are not what we hoped for, our research and work to advance potentially transformative therapies in areas of high unmet need for people living […]
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, […]
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 […]
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 […]
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 […]
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 […]
