SARCOMA

A Prescription Drug User Fee Act target action date of February 17, 2025, has been set for a decision on the vimseltinib application.

The study will evaluate silmitasertib, a novel agent, for the treatment of pediatric and adult patients with relapsed/refractory solid tumors.

The FDA has granted 510(k) clearance to the SeCore™ CDx HLA A sequencing system as companion diagnostic for afamitresgene autoleucel in synovial sarcoma, paving the way for a first-of-its-kind solid tumor therapy.

In an interview with Targeted Oncology, Sandra P. D'Angelo, MD, discussed the approval and supporting data of afamitresgene autoleucel for the treatment of synovial sarcoma.

Afamitresgene autoleucel is now an FDA-approved treatment for patients with advanced synovial sarcoma.

Juneko Grilley-Olson, MD, discussed findings from a phase 2 study investigating the addition of immunotherapy to chemotherapy for the treatment of advanced angiosarcoma.

Adam C. Berger, MD, FACS, highlights the challenges and advancements in diagnosing and treating sarcoma, a rare and diverse group of cancers originating from mesenchymal tissues.

Elizabeth Loggers, MD, PhD, discussed the phase 3 DeFi study exploring ovarian toxicity in female patients receiving nirogacestat for the treatment of desmoid tumors.

The first patient with metastatic sarcoma in the US has been treated with INT230-6 alone in the phase 3 INVINCIBLE-3 study.

The FDA has granted an orphan drug designation to tigilanol tiglate for the treatment of soft tissue sarcoma.

Early data of afamitresgene autoleucel suggest substantial benefits for those with advanced synovial sarcoma who haven't responded to other treatments.

In an interview with Targeted Oncology, Lisa B. Ercolano, MD, discussed the evolving treatment landscape for sarcomas and underscored the pivotal role of molecular profiling, while addressing the need for more efficacious systemic therapies.

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.

INT230-6 is an investigational product candidate made up of cisplatin, vinblastine, and a penetration enhancer molecule being evaluated for patients with soft tissue sarcoma.

Various combination strategies are being explored in soft tissue sarcomas in efforts to increase efficacy.

For Sarcoma Awareness Month, Lisa B. Ercolano, MD, and Mark Agulnik, MD, discussed the importance of understanding the genomics of sarcomas and how molecular testing can be useful in this space.

Among patients with unresectable or metastatic undifferentiated pleomorphic sarcoma or myxofibrosarcoma, envafolimab generated positive efficacy data with a well-tolerated safety profile.

Treatment with INT230-6 alone led to extended survival among patients with soft tissue sarcoma by nearly 450 days, compared with synthetic controls, and demonstrated a favorable safety profile.

The combination of doxorubicin, balstilimab, and zalifrelimab has some early signals of activity in both immune hot and cold sarcoma subtypes with manageable toxicity.

Correlative work is ongoing following positive results from the phase 1 study of cabozantinib with nivolumab and ipilimumab.

No progression-free survival advantage was shown with milademetan compared with trabectedin in the phase 3 MANTRA study.

According to Alice P. Chen, MD, the phase 2 study of atezolizumab alone or atezolizumab plus bevacizumab has a unique design.

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.

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.

Data from an analysis of the combined NRG-RTOG 0630/9514 trials show that pathologic complete response can be used as a prognostic factor for clinical outcomes in future research of patients with soft tissue sarcoma.

In an interview with Targeted Oncology, Neeta Somaiah, MD, explained how targeted therapies have started to re-shape the treatment of sarcomas and the potential role of immunotherapy in the future.

Both pediatric brain cancers and sarcomas have an extremely dismal outcome in the relapse setting, according to Catherine Bollard, MD. A new Cancer Grand Challenge aims to address the issue with the development of new therapies.

A phase 1 trial showed efficacy of a novel T-cell therapy targeting MAGE-A4 in solid tumors, particularly synovial sarcoma.

In an interview with Targeted Oncology, Matthew A. Ingham, MD, explains the uniqueness of uterine sarcomas and how years of research around these tumors have led to advances in precision medicine for patients.

Investigators in the IT-01 trial of INT230-6 as monotherapy or combined with ipilimumab showed safety and potential efficacy in patients with sarcoma.