Jordyn Sava

TPST-1120 shows promising efficacy and safety data in a phase 1b/2 study of the agent among patients with unresectable or metastatic hepatocellular carcinoma.

The TRANSCEND FL and TRANSCEND NHL 001 studies of lisocabtagene maraleucel met its primary end point of overall response rate and secondary end point of complete response rate in patients with follicular lymphoma and B-cell non-Hodgkin lymphoma.

Treatment with TARA-002 at 3 different dose levels was generally well-tolerated, and no dose limiting toxicities were observed among patients with high-grade non-muscle invasive bladder cancer.

Here is a look back at all of the FDA happenings from April 2023.

Findings from the COMMANDS study in which luspatercept showed statistically significant and clinically meaningful improvements for patients with low-risk myelodysplastic syndrome, the FDA has set a target action date of August 28, 2023.

The combination of lenvatinib and pembrolizumab continued to show benefits in efficacy vs chemotherapy among patients with endometrial cancer treated in Study 309/KEYNOTE-775.

In an interview with Targeted Oncology, Ken Kato, MD, PhD, discussed background and findings from the phase 3 CheckMate 648 trial among patients with esophageal squamous cell carcinoma.

The prespecified interim analysis of the RENOTORCH study showed toripalimab plus axitinib improved progression-free survival, overall response rates, and showed no new safety signals among patients with renal cell carcinoma.

This trial of HST-1011 will evaluate the safety, tolerability, pharmacokinetics, harmacodynamics, and preliminary clinical activity of the agent when administered as a monotherapy or in combination with cemiplimab.

The use of DecisionDx-Melanoma to guide better risk-aligned care for patients with cutaneous melanoma who are considered low-risk by staging is supported by study findings.

As we better understand the use of artificial intelligence in oncology, experts can improve outcomes, develop approaches to solve problems, advance the development of treatments that are made available to patients with cancer, and more.

Treatment with ceralasertib with and without olaparib showed promising signals of clinical activity in multiple rare gynecologic cancers, according to findings presented at the European Society for Medical Oncology Gynaecologic Cancers Congress 2023.

A patient treated with the second highest dose level of FHD-609 had a grade 4 adverse event. Enrollment in the study of the agent in patients with synovial sarcoma or SMARCB-1 deleted tumors has been halted.

Promising results from a type C meeting with the FDA has led to a phase 2/3 trial of darovasertib and crizotinib being initiated in 2023 for patients with first-line HLA-A2 negative metastatic uveal melanoma.

Promising efficacy has been seen with the use of immunotherapy for the management of patients with hepatocellular carcinoma, Now, durvalumab and tremelimumab combination therapy is being studied for this patient population listed for a liver transplant.

A phase 1 trial of EPI-7386 will evaluate the safety, pharmacokinetics, drug-drug interactions, and preliminary anti-tumor activity of the agent in combination with apalutamide or abiraterone acetate plus prednisone.

The new Prescription Drug User Fee Act action date for quizartinib for use in patients with newly diagnosed FLT3-ITD-positive acute myeloid leukemia has been set to July 24, 2023.

Findings presented at the ASCO April Plenary Series showed that there was a significant event-free survival improvement among patients treated with toripalimab in the phase 3 Neotorch study.

In an interview, Samer A. Srour, MD, MS, reviewed data from the dose-expansion phase of an ongoing phase 1 trial of Orca-Q in the haploidentical stem cell transplant setting for patients with high-risk hematologic malignancies.

In an interview with Targeted Oncology, Mitchell E. Horwitz, MD, discussed the FDA approval of omidubicel for the treatment of patients with blood cancers in need of an allogeneic hematopoietic stem cell transplant.

Complete remission was achieved in 99% patients with refractory leukemia or hematologic relapse when treated with CD19- and CD22-chimeric antigen receptor T-cell therapy in a phase 2 trial.

DKN-01, an anti-DKK1 antibody, is being evaluated with bevacizumab and chemotherapy for patients with advanced colorectal cancer in the phase 2 DeFianCe trial.

The safety, tolerability, pharmacokinetics, and pharmacodynamics of IDE161, a potent, selective, small-molecule inhibitor of PARG, is being evaluated in a phase 1 clinical trial for advanced solid tumors.

In an interview, Ashish Saxena, MD, discussed the benefit of radiation for the treatment of small cell lung cancer, combining radiation with immune checkpoint blockade treatments, and the next steps for the space.

Data presented at the 2023 AACR Annual Meeting on treatment with BGB-3245 in advanced or refractory tumors with a mutation in the MAPK pathway support ongoing investigations of BGB-3245 in defined cohorts during the dose-expansion portion of a phase 1a/1b trial.

Omidubicel showed encouraging clinical benefit in a phase 3 study vs standard myeloablative umbilical cord blood in patients with blood cancers in need of an allogeneic hematopoietic stem cell transplant. Now, the FDA has approved the agent for this indication.

Positive data from the phase 3 KarMMA-3 study has led to multiple regulatory applications being accepted for ide-cel as a treatment option for patients with relapsed/refractory multiple myeloma.

Using the recommended doses of 50 and 70 mg per day from a phase 1a trial of NXP800, the agent will be further evaluated in patients with platinum-resistant, ARID1a-mutated ovarian cancer.

The FDA has requested positive results from a second clinical study of SGX301 in patients with early stage cutaneous T-cell lymphoma before filing a new drug application.

The FDA has now granted OM-301 2 orphan drug designations for the treatment of patients with multiple myeloma and acute myeloid leukemia.