Galera Announces Topline Results from Phase 2a AESOP Trial of Avasopasem for Chemoradiotherapy-Induced Esophagitis

Galera Therapeutics

MALVERN, PA — Galera Therapeutics, Inc. (Nasdaq: GRTX) this week announced topline results from the six-week, Phase 2a, open-label, single-arm AESOP trial of avasopasem evaluating its ability to reduce the incidence of severe acute radiation-induced esophagitis in patients with lung cancer receiving concurrent chemoradiotherapy.

The multicenter Phase 2a trial enrolled 39 patients (62 screened) with unresectable Stage 3A/3B or post-operative Stage 2B non-small cell (NSCLC) or limited-stage small cell (SCLC) lung cancers. Thirty-five patients completed treatment with 60 gray of intensity-modulated radiation therapy (IMRT) plus chemotherapy over six weeks. Of these 35 patients, 29 received at least five weeks of 90 mg of avasopasem on the days they underwent IMRT. These 29 patients were evaluated as the pre-specified per protocol population. Patients enrolled in this trial were considered at high risk for developing esophagitis due to the amount of radiation planned to be delivered to the esophagus.1 Patients were assessed and classified according to NCI-CTCAE criteria.2

Incidence of esophagitis by grade and timepoint in the AESOP trial (per protocol, n=29):

Weeks of IMRT
1 2 3 4 5 6
Grade 2 10% 17% 38% 48% 45%
Grade 3 3% 3%
Grade 4 or 5
Grading Scale for Esophagitis per NCI Criteria
Grade 1 Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2 Symptomatic; altered eating/swallowing; oral supplements indicated
Grade 3 Severely altered eating/swallowing; tube feeding, TPN, or hospitalization indicated
Grade 4 Life-threatening consequences; urgent operative intervention indicated
Grade 5 Death
Only two of the 29 patients (7%) experienced Grade 3 esophagitis at any time, with neither patient experiencing Grade 3 for more than one week. No patients experienced Grade 4 or 5 esophagitis at any point during the trial. These data compare favorably to the literature in which approximately 20-30 percent of these patients experienced Grade 3 or 4 esophagitis.3 Avasopasem was generally well tolerated. The adverse events experienced are comparable to those expected with chemoradiotherapy.

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“These encouraging results demonstrate avasopasem’s potential to meaningfully reduce radiotherapy-induced Grade 3 or worse esophagitis,” said Mel Sorensen, M.D., Galera’s President and CEO. “Patients with lung cancer undergoing chemoradiotherapy are at high risk of severe and potentially life-threatening esophagitis, including an inability to eat or swallow, severe pain, ulceration, infection, bleeding and weight loss, and there are no established drug therapies. Following the positive Phase 3 results of avasopasem in radiotherapy-induced severe oral mucositis (SOM), we believe these results in esophagitis support the safety and efficacy of avasopasem as a potential therapy to prevent the most severe forms of radiotherapy-induced toxicities.”

Approximately 50,000 lung cancer patients undergo standard-of-care chemoradiotherapy every year in the U.S. and are at risk of developing esophagitis.

1 Palma, DA. (2013). Int J Radiation Oncol Biol Phys, Vol. 87 (4), 690-696.
2 NCI Common Toxicity Criteria 5.0.
3 LAMP Study. Belani, CP et al. (2005). J Clin Oncol, 23:5883-5891 (carboplatin + paclitaxel chemo); RTOG 9410. Curran, WJ et al. (2011). J Natl Cancer Inst, 103:1452–1460 (cisplatin + vinblastine).

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