Oncology

Single-arm, open-label, multicenter, non-randomized, multicohort Phase II VISION trial (NCT02864992) of Tepmetko (tepotinib) for metastatic non–small cell lung cancer shows favorable objective response rate.

There were no safety or efficacy issues identified in the FDA's complete response letter for Lymphir, with no additional trials required.

Trials of Augtyro are ongoing for this tumor-agnostic indication, which could provide a durable treatment option for patients with NTRK-positive disease.

The Onivyde combination was evaluated in the open-label, multicenter, randomized Phase III NAPOLI 3 trial, showing significantly improved overall survival in patients with metastatic pancreatic adenocarcinoma.

Phase II trial data show positive survival results for BXCL701 combined with Keytruda (pembrolizumab) to treat patients with metastatic small cell neuroendocrine prostate cancer.

Samsung Biologics will provide antibody development and drug substance manufacturing services for LegoChem Biosciences' antibody-drug conjugate program with hopes of submitting an Investigational New Drug application to the FDA in 2025.

Gilead announced it will discontinue the clinical development of magrolimab for hematologic cancers after the drug in combination with azacitidine plus Venclexta showed an increased risk of death related to infections and respiratory failure in patients with acute myeloid leukemia.

Data from the Phase I/II VERITAC trial (NCT04072952) showed promising findings for vepdegestrant in patients with ER-positive/HER2-negative locally advanced or metastatic breast cancer.

Phase III trial shows efficacy of Opdivo (nivolumab) plus chemotherapy followed by surgery and adjuvant Opdivo in the perioperative treatment of resectable stage IIA to IIIB non-small cell lung cancer.

Blenrep with bortezomib plus dexamethasone produced a significant improvement to median progression-free survival in the treatment of relapsed or refractory multiple myeloma compared with standard of care combination therapy.

The ongoing Phase I/II NCT05438329 trial is evaluating BNT325/DB-1305 in patients with platinum-resistant ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer previously administered one to three systemic treatment regimens.

Data from the Phase II Nivolumab and Ipilimumab Plus/minus UV1 vaccination (NIPU) clinical trial show UV1 off-the-shelf cancer vaccine plus ipilimumab (Yervoy) and nivolumab (Opdivo) improved survival in patients with unresectable malignant pleural mesothelioma.

Efineptakin alfa, the only clinical stage long-acting human interleukin-7, is currently being evaluated in Phase I/II clinical trials in combination with pembrolizumab (Keytruda) for patients with advanced solid tumors, including pancreatic cancer.

Ensuring equitable access to new technologies and integrating AI to benefit all communities remain critical challenges to overcome.

Biosyngen’s BST02 is a cell-based immunotherapy that began clinical trials in October 2023 for all types of liver cancer.

Afami-cel was developed to target the MAGE-A4 protein in synovial sarcoma, which comprises 5% to 10% of soft tissue sarcomas.

The manufacturing process for CAR T-cell therapies is vital in preparing a patient’s cells for a one-time cell therapy infusion that is specifically tailored to meet each patient’s needs.

Research collaboration between DELFI and Immunocore Holdings will investigate the potential of the DELFI-TF assay in predicting the efficacy of ImmTAC-based treatments early in the therapy process.

Darzalex Faspro with bortezomib, lenalidomide, and dexamethasone for induction and consolidation therapy and in combination with maintenance lenalidomide found to improve survival in patients with multiple myeloma who are eligible for autologous stem cell transplant.

The Padcev/Keytruda combination produced statistically significant and clinically meaningful improvements to survival compared to platinum-containing chemotherapy in first-line treatment of adults with previously untreated locally advanced or metastatic urothelial cancer.

Phase II TRANSCEND FL and Phase I TRANSCEND NHL 001 trial data lead to FDA Priority Review designation for Breyanzi to treat relapsed or refractory follicular lymphoma and mantle cell lymphoma.

Trial shows Keytruda improved overall survival by 38% compared with placebo in in patients with renal cell carcinoma at intermediate-high or high risk of recurrence after nephrectomy or nephrectomy and resection of metastatic lesions.

The Priority Revew designation was based on findings from the ongoing, global, multicenter, multi-cohort, open-label Phase II DESTINY-PanTumor02 trial of of Enhertu for patients with previously treated HER2-expressing tumors, including biliary tract cancer, bladder cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and other tumor types.

The FDA made the decision to require boxed warnings on CAR T-cell therapies based on reports of T-cell malignancies in patients administered BCMA- or CD19-directed autologous CAR T-cell immunotherapies.

FDA accepts biologics license application from Autolus Therapeutics for obecabtagene autoleucel to treat adults with relapsed or refractory B-cell acute lymphoblastic leukemia.

NK010 is a non-genetically modified natural killer cell therapy that dislayed significant potential in inhibiting strong tumor growth on ovarian cancers in animal studies.

Satri-cel (satricabtagene autoleucel) showed a promising safety and efficacy profile in patients with gastric or gastroesophageal cancer and pancreatic cancer.

Opdivo (nivolumab) with Yervoy (ipilimumab) improved progression-free survival in patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer.

Balversa (erdafitinib) is a fibroblast growth factor inhibitor granted accelerated approval by the FDA in April 2019 for adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic mutations whose disease progressed on or following one line of systemic therapy.

Data from the NETTER-2 trial show that first-line treatment with Lutathera plus long-acting release octreotide lowered the risk of disease progression or death by 72% in patients with advanced gastroenteropancreatic neuroendocrine tumors.