Jordyn Sava

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.

The effects of chemotherapy-induced myelosuppression for extensive-stage small cell lung cancer were assessed in a new study which used a real-world community oncology setting.

In an interview with Targeted Oncology, Ajay Nooka, MD, discussed findings from the phase 3 KarMMa-3 trial and the use of ide-cel for the treatment of patients with relapsed/refractory multiple myeloma.

Results from the EARLY-MYO-BC trial assessing the pyrotinib’s cardiac impacts may help researchers select an appropriate anti-HER2 treatment when managing patients with HER2-positive breast cancer.

Mirvetuximab soravtansine is being assessed in combination with bevacizumab as a treatment for patients with folate receptor-alpha-positive recurrent platinum-sensitive ovarian cancer.

Topline data from part A of the THIO-101 trial showed that patients treated with THIO plus cemiplimab had mild toxicities, including grade 1 fatigue and muscle pain, and 1 case of grade 3 nausea among patients with non–small cell lung cancer.

A phase 2, open-label clinical trial is evaluating treatment with QBS72S in patients with histologically-confirmed breast cancer that has developed brain metastases after a prior cytotoxic chemotherapy regimen.

In a study performed at MD Anderson Cancer Center, there was no significant overall survival impact in patients with anaplastic thyroid cancer who had prior differentiated thyroid cancer, concomitant differentiated thyroid cancer, and prior non thyroid cancers.

TP-1287, an investigational oral phosphate prodrug of the CDK9 inhibitor alvocidib, has been granted an orphan drug designation by the FDA for patients with Ewing sarcoma.

CB-011 has received a fast track designation from the FDA for the treatment of relapsed/refractory multiple myeloma and is being investigated in the ongoing CaMMouflage study.

The phase 3 Karmma-3 trial of ide-cel in patients with triple-class-exposed relapsed/refractory multiple myeloma generated significantly improved progression-free survival and overall response rates vs standard regimens.

A first-in-human study is assessing the safety, efficacy, and pharmacokinetics of DK210 as a monotherapy and in combination with immunotherapy, radiotherapy, or chemotherapy for patients with EGFR-expressing solid tumors.

In the KEYNOTE-045 and KEYNOTE-052 trials, pembrolizumab continued to led to durable responses with no new safety signals after 5 years.

With 1.5 years of follow-up, the confirmed objective response rate was 92.5% among patients who were ROS1 tyrosine kinase inhibitor-naïve and 52.6% in crizotinib-pretreated patients in the phase 2 TRUST-I trial.

Neither the LEAP-003 nor LEAP-017 studies study showed survival benefit with pembrolizumab plus lenvatinib for patients with melanoma or colorectal cancer.

In an interview with Targeted Oncology, Bridget Koontz, MD, discussed burnout and its importance in experts treating patients with cancer.

The investigational new drug, SynKIR-110, has received a fast track designation from the FDA for patients with mesothelioma and is continuing to be evaluated in a phase 1 trial.