Joseph Aloysius Ludwig, Noah C. Federman, Peter Meade Anderson, et al.
TK216 is a first-in-class small molecule inhibiting the biological activity of ETS-family (E26 Transformation - Specific) transcription factor oncoproteins. The authors of the study conclude that this drug plus vincristine was well tolerated. The drug showed encouraging early evidence of anti-tumor activity in this heavily pre-treated/ high tumor burden sewing sarcoma patient population. Clinical trial information: NCT02657005
Efficacy of dose intensification in induction therapy for localized Ewing sarcoma: Italian Sarcoma Group (ISG) and Associazione Italiana Ematologia ed Oncologia Pediatrica (AIEOP) ISG/AIEOP EW-1 study.
Roberto Luksch, Giuseppe Maria Milano, Francesco Barretta, et al.
The authors of the study conclude that Intense induction therapy with arm B did not improve 5-year event-free survival versus standard arm A. The authors note, that the higher toxicity observed in arm B versus arm A was counterbalanced, in good responders, by a similar outcome with a shorter treatment plan. For poor responders, with almost 30 patients per arm event-free and with < 48-month follow-up, better 5-year event-free survival in arm B than in arm A was observed. Clinical trial information: NCT02063022
Association of treatment delays with an unfavorable outcome in patients with localized Ewing sarcoma: A retrospective analysis of data from the GPOH Euro-E.W.I.N.G.99 trial.
Uta Dirksen, Andreas Ranft, Daniel Baumhoer, et al.
The authors of the study demonstrate that delays between induction chemotherapy and surgery and between surgery and consolidation chemotherapy are independently associated with a poor outcome in patients with localized Ewing sarcoma. These results underscore the need to treat these patients in larger and experienced sarcoma centers. to reduce perioperative morbidity and treatment delays the authors recommend the implementation of new and standardized methods in the operative strategy and optimized supportive care during systemic therapy.
P10015/SARC033: A phase 2 trial of trametinib in patients with advanced epithelioid hemangioendothelioma (EHE).
Scott Schuetze, Karla V. Ballman, Kristen N. Ganjoo, et al.
To the knowledge of the authors, their study is the largest prospective clinical study focused on patients with epithelioid hemangioendothelioma (EHE). The trial did not meet the ORR goal, but stable disease over 6 months was seen in 40% of patients, and EHE-related pain improved on treatment. Expected cutaneous and GI adverse effects were observed with Trametinib. Clinical trial information: NCT03148275
SPEARHEAD-1: A phase 2 trial of afamitresgene autoleucel (Formerly ADP-A2M4) in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma.
Sandra P. D'Angelo, Brian Andrew Van Tine, Steven Attia, et al.
The authors of the study demonstrate with these preliminary data that famitresgene autoleucel is efficacious and well-tolerated in heavily pre-treated patients. Objective and deep responses are reported across a wide range of MAGE-A4 antigen levels. Initial durability data is encouraging. The preliminary response data in SPEARHEAD-1 is comparable to earlier findings in the Phase 1 trial. The safety profile of afamitresgene autoleucel is favorable: mainly low-grade cytokine release syndrome and tolerable/reversible hematologic toxicities were observed. Clinical trial information: NCT04044768
A phase III study (APROMISS) of AL3818 (Catequentinib, Anlotinib) hydrochloride monotherapy in subjects with metastatic or advanced synovial sarcoma.
Brian Andrew Van Tine, Sant P. Chawla, Jonathan C. Trent, et al.
AL3818 (Catequentinib, Anlotinib) is a novel, orally-administered, small molecule tyrosine kinase inhibitor. The authors of the study conclude that this phase III trial demonstrates improved disease control and superior progression-free survival for this drug versus dacarbazine in advanced synovial sarcoma. The study also confirms the acceptable benefit-risk profile of AL3818 from the prior randomized Phase 2b soft tissue sarcoma study (NCT02449343). The authors conclude that this drug is a meaningful treatment option for patients with advanced synovial sarcoma. Clinical trial information: NCT03016819
NCI protocol 10250: A phase II study of temozolomide and olaparib for the treatment of advanced uterine leiomyosarcoma.
Matthew Ingham, Jacob B. Allred, Katherine Gano, et al.
The authors conclude that the study met the prespecified primary efficacy endpoint of ORR in a population of patients with heavily pre-treated uLMS. Responses are durable with a median duration of response of 12 months. Clinical trial information: NCT03880019
PD1 inhibition in soft-tissue sarcomas with tertiary lymphoid structures: A multicenter phase II trial.
Antoine Italiano, Alban Bessede, Emmanuelle Bompas, et al.
The authors of the study conclude that the PEMBROSARC study confirms that selection based on TLS status is an efficient approach to tailor immunotherapy in STS patients. There was an objective response and a 6-month non-progression rate of 26.7% and 40% respectively versus 2.1% and 4.2% in all comers. Clinical trial information: NCT02406781
Phase II trial of pegylated arginine deiminase in combination with gemcitabine and docetaxel for the treatment of soft tissue sarcoma.
Brian Andrew Van Tine, Angela C. Hirbe, Jingqin Luo, et al.
The authors of the study conclude that the combination of pegylated arginine deiminase (ADI-PEG20) with G+D can be safely and effectively given at a dose of 600mg/m2 G and 60mg/m2 D. Clinical trial information: NCT03449901