231 0 Kommentare Immunomedics Announces Encouraging Early-Stage Clinical Results with Trodelvy in Brain Cancers - Seite 2

“Brain metastasis is a significant concern in patients with TNBC, and we are very encouraged by these early-stage study results,” stated Dr. Loretta M. Itri, Chief Medical Officer of Immunomedics. “Additionally, given that GBM is a disease with great unmet need, we are working in close collaboration with Dr. Brenner and others, including the Southwestern Oncology Group, to design programs that could potentially elucidate the role of Trodelvy in the management of BMBC and rGBM.”

Patients with BMBC or rGBM were enrolled into the single center study (NCT03995706) to receive a single intravenous dose of Trodelvy at 10 mg/kg one day before surgical resection. Tumor and corresponding serum were collected during surgery to measure their levels of SN-38 and its metabolites. Following recovery, patients resumed Trodelvy treatment at 10 mg/kg on days 1 and 8 of 21-day cycles and were assessed for responses by MRI every third cycle using response assessment in neuro-oncology (RANO) criteria.

About Brain Cancer

According to the National Cancer Institute (NCI), an estimated 23,890 American will be diagnosed with brain cancer in 2020 and about 18,020 people will die from the disease in the U.S. this year.² Among the numerous brain tumor types, glioblastoma (GBM) is the most aggressive, with median progression-free survival (PFS) and median overall survival (OS) from diagnosis of 6.2-7.5 months and 14.6-16.7 months, respectively, having been reported in clinical trials.^3-6 For patients with recurrent GBM, chemotherapy regimens are associated with overall response rates of 4-9%, 6‑month PFS of 10-19%, and median OS of 5-10 months.^7–11

References

Pandey R, Gruslova A, Chiou J, et al. Stable isotope dilution LC-HRMS assay to determine free SN-38, total SN-38, and SN-38G in a tumor xenograft model after intravenous administration of antibody−drug conjugate (sacituzumab govitecan). Anal Chem. 2020;92(1):1260-1267.
https://seer.cancer.gov/statfacts/html/brain.html Accessed on September 17, 2020.
Stupp R, Mason WP, van den Bent MJ, et al. European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005;352(10):987-996.
Gilbert MR, Dignam JJ, Armstrong TS, et al. A randomized trial of bevacizumab for newly diagnosed glioblastoma. N Engl J Med. 2014;370 (8):699-708.
Gilbert MR, Wang M, Aldape KD, et al. Dose-dense temozolomide for newly diagnosed glioblastoma: a randomized phase III clinical trial. J Clin Oncol. 2013;31(32):4085-4091.
Chinot OL, Wick W, Mason W, et al. Bevacizumab plus radiotherapy-temozolomide for newly diagnosed glioblastoma. N Engl J Med. 2014;370 (8):709-722.
Wong ET, Hess KR, Gleason MJ, et al. Outcomes and prognostic factors in recurrent glioma patients enrolled onto phase II clinical trials. J. Clin. Oncol. 17, 2572–2578 (1999).
van den Bent MJ, Brandes AA, Rampling R, et al. Randomized phase II trial of erlotinib versus temozolomide or carmustine in recurrent glioblastoma: EORTC brain tumor group study 26034. J. Clin. Oncol. 27, 1268–1274 (2009).
Batchelor TT, Mulholland P, Neyns B, et al. Phase III randomized trial comparing the efficacy of cediranib as monotherapy, and in combination with lomustine, versus lomustine alone in patients with recurrent glioblastoma. J. Clin. Oncol. 31, 3212–3218 (2013).
Wick W, Puduvalli VK, Chamberlain MC, et al. Phase III study of enzastaurin compared with lomustine in the treatment of recurrent intracranial glioblastoma. J. Clin. Oncol. 28, 1168–1174 (2010).
Taal W, Oosterkamp HM, Walenkamp AME, et al. Single-agent bevacizumab or lomustine versus a combination of bevacizumab plus lomustine in patients with recurrent glioblastoma (BELOB trial): a randomised controlled phase 2 trial. Lancet Oncol. 15, 943–953 (2014).