News

Paul Lammers, MD, MSc, breaks down T-cell antigen coupler technology and its use in various solid tumors.

Combining sotorasib and panitumumab improved progression-free survival for patients with KRAS G12C mutation in metastatic colorectal cancer, based on the phase 3 CodeBreaK 300 trial.

In a subgroup analysis of the phase 3 EMBARK study, enzalutamide alone or with leuprolide acetate improved metastatic-free survival in men with high-risk prostate cancer following radiotherapy.

CMG901 was active and had a manageable safety profile in a heavily pretreated population of patients with CLDN18.2-positive gastric/gastroesophageal junction cancer.

Irrespective of PD-L1 expression, patients treated with domvanalimab, zimberelimab, and chemotherapy in arm A1 of the phase 2 EDGE-Gastric study demonstrated promising overall response rate and 6-month progression-free survival results.

The combination of SRK-181 and pembrolizumab demonstrated improvements in objective response rate among patients with clear cell renal cell carcinoma in a phase 1 proof-of-concept study.

In an interview, Mwanasha Merrill discussed the implication of findings from a phase 2 trial of pembrolizumab after autologous stem cell transplantation for the treatment of patients with peripheral T-cell lymphoma.

Arlene O. Siefker-Radtke, MD, discusses the results of the phase 3 THOR study of erdafitinib vs pembrolizumab in pretreated patients with advanced or metastatic urothelial cancer with select FGFR alterations.

Data from the phase 2 of the RINGSIDE trial have led the FDA to grant an orphan drug designation to AL102 as a potential therapeutic option for patients with desmoid tumors.

Selinexor maintenance therapy shows potential in bettering survival compared with placebo in patients with TP53 wild-type recurrent or advanced endometrial cancer.

As a monotherapy, bispecific antibodies have demonstrated antitumor activity in heavily pretreated patients with B-cell and T-cell hematologic malignancies, but much work is needed to determine the optimal setting.

Bradley McGregor, MD, discusses the rationale behind the multi-institutional, prospective, single-arm phase 2 trial of cabozantinib, nivolumab, and ipilimumab for the treatment of patients with renal cell carcinoma with variant histologies.

Encouraging progression-free survival and ctDNA molecular response rates were seen with SD-101 delivered via pressure-enabled drug delivery plus intravenous checkpoint inhibitors in patients with metastatic uveal melanoma with liver metastases.

In an interview, Funda Meric-Bernstam, MD, discussed the phase 2 DESTINY-PanTumor02 trial and the data on fam-trastuzumab deruxtecan-nxki for the treatment of patients with HER2-expressing cancers.

Findings from the phase 2 RAMP 201 trial show avutometinib plus defactinib demonstrates robust efficacy in patients with recurrent low-grade serious ovarian cancer.

The recent announcement of the 2023 Nobel Prize in Physiology or Medicine has turned attention again to RNA therapeutic vaccines and a better understanding of RNA biology.

Nirav Shah, MD, discusses long-term data from the phase 1/2 BRUIN study which evaluated pirtobrutinib in mantle cell lymphoma, and next steps for evaluating the agent.

Vijaya Raj Bhatt, MBBS, MS, discusses background and findings from a multicenter, phase 2 study of ruxolitinib for the treatment of patients with steroid refractory sclerotic chronic graft-versus-host disease.

Retrospective data shows that a multidisciplinary surgical approach may improve survival in patients with ovarian cancer.

With an investigational new drug granted to ZH9 by the FDA, a clinical development program for the treatment of patients with non-muscle invasive bladder cancer can be initiated.

The combination of dostarlimab and chemotherapy demonstrated meaningful improvements in overall survival for the treatment of primary advanced or recurrent endometrial cancer, according to findings from the phase 3 RUBY trial.

Rhenium obisbemeda shows potential to address the unmet need of new treatment options for patients with breast cancer and leptomeningeal metastases and will continue to be evaluated in the ReSPECT-LM program.

The need for wider accessibility, equity, and affordability are significant factors to consider for advancement of these BiTE therapies.

In an interview with Targeted Oncology, Joseph M. Scandura, MD, PhD, discussed research on pelabresib for the treatment of patients with myeloproliferative neoplasms.

Lucia Masarova, MD, PhD, discusses the rationale of the EXCEED-ET study of ropeginterferon alfa-2b-njf for patients with essential thrombocytopenia.

With a partial clinical hold in place, patient enrollment must halt in the phase 1 NX-2127-001 trial.

The role of risk stratification in treatment decisions for patients with newly diagnosed, transplant eligible multiple myeloma vs newly diagnosed, transplant ineligible multiple myeloma was explored by Natalie S. Callander, MD.

According to findings presented at the Connective Tissue Oncology Society Annual Meeting, INT230-6 enhanced overall survival and disease control rates in relapsed, refractory, and metastatic sarcomas.

With over half of the patients enrolled in the phase 2 trial evaluating paxalisib in relapsed/refractory primary central nervous system lymphoma, some partial responses and stable disease have already been seen.

Here’s a look back at the notable FDA updates from October 2023.