Oncology

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.

The Phase III LUNAR trial (NCT02973789) is evaluating the addition of tumor-treating fields to standard-of-care therapies in patients with non-small cell lung cancer following disease progression on or after platinum-based treatment.

FDA Fast Track Designation precedes an acceleration of enrollment in a Phase I trial of NX-5948 in adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma following at least two lines of therapy that includes a BTK inhibitor and a BCL2 inhibitor.

The 39th overall approval for Keytruda was based on data from the Phase III KEYNOTE-A18 trial in patients with FIGO 2014 stage III to IVA cervical cancer.

An open-label, randomized, dose-optimization Phase II trial (NCT06173037) is assessing the antibody-drug conjugate RC88 to determine the optimal dosage, efficacy, and safety in patients with platinum-resistant ovarian cancer.

SLS009 is a CDK9 inhibitor under evaluation in an ongoing Phase I/II study in patients with relapsed or refractory acute myeloid leukemia.

Shorla Oncology’s New Drug Application for SH-105 for breast and ovarian cancers was given a Prescription Drug User Fee Act action date of June 29, 2024.

The FDA's complete response letter was not related to clinical trial data for efficacy or safety for zolbetuximab for the treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction.

Merck is actively enrolling patients for investigational drugs that treat essential thrombocythemia, chronic lymphocytic leukemia, small lymphocytic lymphoma, non-small cell lung cancer, endometrial carcinoma, and metastatic castration-resistant prostate cancer.

Parents of children with cancer and limited health literacy were associated with lower comprehension of informed consent.

Phase III RUBY/ENGOT-EN6/GOG3031/NSGO trial show a statistically significant and clinically meaningful benefit for Jemperli plus standard-of-care chemotherapy with carboplatin and paclitaxel, followed by Jemperli plus Zejula across the overall patient population and among a subpopulation of patients with MMRp/MSS tumors in those with primary advanced or recurrent endometrial cancer.

New research initiative will investigate the potential of zanidatamab as a monotherapy and in combination with other treatments for patients with different tumor types and stages.

The approval of pembrolizumab (Keytruda; Merck) combined with gemcitabine and cisplatin for the treatment locally advanced unresectable or metastatic biliary tract cancer is the sixth sixth indication for the anti-PD-1 therapy for gastrointestinal cancers.

In this Q&A, Matt Smith, Vice President Research Site Development, Slope discusses the competition pharma companies and trial sponsors face when trying to become a sponsor of choice and build trust with sites and patients.

The fear of exposure to SARS-CoV-2 in healthcare settings has deterred people from seeking care for non-COVID-19 diseases. One solution to patient care and biomedical research disruptions is implementing remote solutions for conducting research and collecting samples.

Recent case study highlights the importance of applying statistical rigor throughout the development and validation processes of biomarkers.

Distinguishing CAR-T and CPI approaches and the clinical trial challenges and complexities associated with each.

A look at one company’s platform approach in enabling the engineering of T-cells to identify and destroy cancer.

Cancer's R&D Convergence will highlight the changing landscape for clinical trials in this therapeutic area based on the promise of the Cancer MoonShot initiative, along with new oncology immunotherapies.

The war on cancer has seen significant strides made in the search for a cure, however, recent data suggests that the work is far from over.

How to meet the rigorous safety and efficacy demands critical to evaluating newer targeted cancer therapies.