Randomized, Double-Blind, Placebo-Controlled Phase II Study of Yeast-Brachyury Vaccine (GI-6301) in Combination with Standard-of-Care Radiotherapy in Locally Advanced, Unresectable Chordoma.

CONCLUSION: No difference in overall response rate was observed, leading to early discontinuation of this trial due to low conditional power to detect statistical difference at the planned end of accrual.
IMPLICATIONS FOR PRACTICE: Chordoma is a rare neoplasm lacking effective systemic therapies for advanced, unresectable disease. Lack of clinically actionable somatic mutations in chordoma makes development of targeted therapy quite challenging. While the combination of yeast-brachyury vaccine (GI-6301) and standard radiation therapy did not demonstrate synergistic antitumor effects, brachyury still remains a good target for developmental therapeutics in chordoma. Patients and their oncologists should consider early referral to centers with expertise in chordoma (or sarcoma) and encourage participation in clinical trials.
PMID: 33594772 [PubMed - as supplied by publisher]

Source: The Oncologist - February 17, 2021 Category: Cancer & Oncology Authors: DeMaria PJ, Bilusic M, Park DM, Heery CR, Donahue RN, Madan RA, Bagheri MH, Strauss J, Shen V, Marte JL, Steinberg SM, Schlom J, Gilbert MR, Gulley JL Tags: Oncologist Source Type: research