Author: By Lynda Williams, Senior medwireNews Reporter
medwireNews: A novel immunotherapy (IO) strategy of using avelumab before, during and after carboplatin–gemcitabine chemotherapy has failed to improve the outcome of treatment-naïve advanced urothelial carcinoma (UC) patients who are ineligible for a cisplatin-based regimen.
The phase II INDUCOMAIN trial findings were reported by Begoña Perez Valderrama, from Hospital Universitario Virgen del Rocío in Seville, Spain, at the ESMO Virtual Congress 2020.
The primary endpoint of overall response rate (ORR) was 57.1% for the 42 patients with unresectable or metastatic UC who were randomly assigned to receive a first-line regimen consisting of induction avelumab 10 mg/kg every 2 weeks for two cycles, followed by six cycles of avelumab 10 mg/kg every 3 weeks plus a standard carboplatin–gemcitabine regimen, and then maintenance avelumab 10 mg/kg every 2 weeks.
This did not significantly differ from the ORR of 53.5% for the 43 patients who instead received only the carboplatin–gemcitabine regimen, the presenting author said.
Nor was there a significant difference between the avelumab and chemotherapy-only treatment arms for median progression-free survival (6.9 vs 7.4 months) or overall survival (10.5 vs 13.2 months), although the overall survival rate at 15 months was numerically higher with avelumab, at 51.28% versus 38.96% with the control regimen.
However, Begoña Perez Valderrama also reported that 31.0% of patients in the avelumab arm progressed or died by the time of the first planned response assessment versus 9.3% of the chemotherapy only arm, despite no difference in adverse prognostic factors between the groups.
There were no new toxicities reported for avelumab or chemotherapy, with 41.5% of avelumab-treated patients experiencing grade 3 or more severe adverse events associated with the immunotherapy.
“Induction IO alone before [chemotherapy] IO is not an adequate strategy”, stated the presenter, concluding that the working hypothesis that “IO before [chemotherapy] might optimize subsequent chemotherapy response was not proven.”
Begoña Perez Valderrama added that phase III trials are currently investigating alternative sequences or combinations of immunotherapies and chemotherapies.
Perez Valderrama B, Castellano Gauna D, Pinto Marin A, et al. Phase II multicenter, randomized study to evaluate efficacy and safety of avelumab with gemcitabine/carboplatin (CG) vs CG alone in patients with unresectable or metastatic urothelial carcinoma (mUC) who are ineligible to receive cisplatin-based therapy (“INDUCOMIN”). Ann Oncol 2020; 31 (Suppl_4): S1142–S1215. DOI: 10.1016/annonc/annonc325.
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