Sara Karlovitch

The first patient has been dosed in the phase 1/2a clinical trial, designed to evaluate LAVA-051- a gamma-delta bispecific gamma-delta T cell engager that activates Vγ9Vδ2 T cells and type 1 natural killer T cells-in those with chronic lymphocytic leukemia, multiple myeloma, and acute myeloid leukemia.

The Fox Chase Cancer Center at Temple University in Philadelphia, Pennsylvania has been added as an active trial site by Salarius Pharmaceuticals, Inc. for the ongoing trial of seclidemstat for the treatment of relapsed or refractory Ewing sarcoma and advanced FET-rearranged sarcomas.

The combination of the ant-PD-1 inhibitor, pembrolizumab plus chemotherapy before surgery continued by pembrolizumab as a single agent led to statistically significant event-free survival result versus neoadjuvant chemotherapy alone in patients with high-risk early-stage triple-negative breast cancer.

In an interview with Targeted Oncology, Stephanie Lee, MD, MPH, reviewed the updated data from the REACH3 trial along with the efficacy of ruxolitinib in the greater chronic graft versus host disease population.

The American Society of Clinical Oncology and the Community Oncology Alliance released new Oncology Medical Home standards that are designed to help guide care providers as they treat patients.

In an interview with Targeted Oncology, Rachel N. Grisham, MD, discussed binimetinib’s effect on patients with ovarian cancer harboring a KRAS mutation. 

The first patient with a solid tumor has been dosed in the TiTAN-1 clinical trial, which is aiming to determine the safety, tolerability, and efficacy of GEN-011, a next-generation neoantigen adoptive cell therapy.

In an interview with Targeted Oncology, David W. Dougherty, MD, discussed how the COVID-19 pandemic has changed the cancer care space.

The FDA has granted approval to enfortumab vedotin for the treatment of adult patients with locally advanced or metastatic urothelial cancer.

ARO-HIF2, an investigational tumor-targeting medicine utilizing the Targeted RNAi molecule platform from Arrowhead Pharmaceuticals, Inc., may be a safe and effective treatment for patients with clear cell renal cell carcinoma.

The ELI-002 vaccine, which targets lymph nodes in patients with KRAS-driven tumors, may be a potential treatment for those with KRAS-driven tumors who have minimal residual disease following tumor resection. A current phase 1/2 dose-escalation study is currently underway to test this hypothesis.

ALX148, a CD47 inhibitor in combination with chemotherapy and trastuzumab is a safe and well-tolerated treatment for patients with second-line or greater HER2-positive gastroesophageal junction cancer.

A phase 1b trial is currently recruiting patients with advanced p53-mutated non­–small cell lung cancer in order to determine the safety and efficacy of ALRN-6924, and reduce chemotherapy toxicity in this patient population.

Pembrolizumab monotherapy demonstrated improvement in health-related quality of life in patients with previously treated metastatic microsatellite instability-high/ mismatch repair deficient advanced noncolorectal solid tumors, with the biggest improvements seen in those who achieved a complete remission or partial remission.

Here is a look back at the FDA news from June 2021.

Increasing the dose of the primary treatment modality for anal squamous cell carcinoma, chemoradiotherapy, may further improve efficacy for patients with effective organ preservation and disease control.

Balixafortide in combination with eribulin did not improve objective response rate compared to eribulin alone for the treatment of HER2-negative, locally recurrent or metastatic breast cancer, missing the coprimary end point of the FORTRESS study.

The FDA has granted breakthrough therapy designation to orelabrutinib, a Bruton’s tyrosine kinase inhibitor, for the treatment of relapsed or refractory mantle cell lymphoma.

As June is Cancer Immunotherapy Month, Mehmet Akce, MD, discusses the future of immunotherapy in HCC in an interview with Targeted Oncology.

Across the United States, the health insurance coverage gap continues to impact millions of patients who are largely low-income or are racial minorities. After years of lobbying, Congress has passed the Clinical Treatment Act, which is legislation designed to improve access to health coverage.

The FDA has granted a breakthrough therapy designation from the FDA for patients with advanced non-small cell lung cancer with a KRASG12C mutation following prior systemic treatment.

In an interview with Targeted Oncology, Kathleen Moore, MD, discusses the effects of niraparib for ovarian cancer in the earlier-line setting in more detail and how she anticipates it will change clinical practice. 

The combination of camrelizumab and apatinib has shown long-term survival benefit in patients with advanced hepatocellular carcinoma, according to updated results from the RESCUE trial.

The investigational next-generation tyrosine kinase inhibitor, taletrectinib has been dosed for the first time in a patient with an NTRK fusion-positive solid tumor being treated in a phase 2 study.

In an interview with Targeted Oncology, Peter Riedell, MD, discussed an analysis of how time to relapse impacts survival. He also explained what the study findings mean for clinical practice.

In an interview with Targeted Oncology, Aaron Lisberg, MD spoke on the importance of molecular testing for patients with lung adenocarcinoma, and provided tips for choosing between immunotherapy and a tyrosine kinase inhibitor.

A supplemental new drug application has been submitted to the FDA seeking approval for the combination of copanlisib and rituximab for the treatment of relapsed indolent B-cell non-Hodgkin’s Lymphoma and is outside of the FDA accelerated approved indication for the treatment of relapsed follicular lymphoma who have received at least 2 prior systemic therapies.

Type C meeting responses from the FDA have led to the finalization of the clinical development approach of STAR-OLZ, a multi-day transdermal olanzapine patch, for the treatment of chemotherapy induced nausea and vomiting.

The FDA has granted an orphan drug designation to gunagratinib (ICP-192) for the treatment of cholangiocarcinoma.

The FDA has granted breakthrough therapy designation to 177Lu-PSMA-617, an investigational radioligand therapy for the treatment of metastatic castration-resistant prostate cancer.