In resectable gastric or gastroesophageal junction cancer (GC/GEJC), the powerful positive prognostic effect and the potential predictive value for a lack of benefit from the combination of adjuvant/peri-operative chemotherapy for the MSI-high status was demonstrated. Given the high sensitivity of MSI-high tumors for immunotherapy, exploratory trials showed that combination immunotherapy induces a high rate of complete pathological response (pCR), potentially achieving cancer cure without surgery. INFINITY is an ongoing phase II, multicentre, single-arm, multi-cohort trial investigating the activity and safety of tremelimumab and durvalumab as neoadjuvant (Cohort 1) or potentially definitive (Cohort 2) treatment for MSI-high/dMMR/EBV-negative, resectable GC/GEJC. About 310 patients will be pre-screened, to enroll a total of 31 patients, 18 and 13 in Cohort 1 and 2, at 25 Italian Centres. The primary endpoint of Cohort 1 is rate of pCR (ypT0N0) and negative ctDNA after neoadjuvant immunotherapy, of Cohort 2 is 2-year complete response rate, defined as absence of macroscopic or microscopic residual disease (locally/regionally/distantly) at radiological examinations, tissue and liquid biopsy, during non-operative management without salvage gastrectomy. The ongoing INFINITY proof-of-concept study may provide evidence on immunotherapy and the potential omission of surgery in localized/locally advanced GC/GEJC patients selected for dMMR/MSI-high status eligible for radical resection.

TremelImumab and Durvalumab Combination for the Non-OperatIve Management (NOM) of Microsatellite InstabiliTY (MSI)-High Resectable Gastric or Gastroesophageal Junction Cancer: The Multicentre, Single-Arm, Multi-Cohort, Phase II INFINITY Study / Raimondi, Alessandra; Palermo, Federica; Prisciandaro, Michele; Aglietta, Massimo; Antonuzzo, Lorenzo; Aprile, Giuseppe; Berardi, Rossana; Cardellino, Giovanni G; De Manzoni, Giovanni; De Vita, Ferdinando; Di Maio, Massimo; Fornaro, Lorenzo; Frassineti, Giovanni L; Granetto, Cristina; Iachetta, Francesco; Lonardi, Sara; Murialdo, Roberto; Ongaro, Elena; Pucci, Francesca; Ratti, Margherita; Silvestris, Nicola; Smiroldo, Valeria; Spallanzani, Andrea; Strippoli, Antonia; Tamberi, Stefano; Tamburini, Emiliano; Zaniboni, Alberto; Di Bartolomeo, Maria; Cremolini, Chiara; Sposito, Carlo; Mazzaferro, Vincenzo; Pietrantonio, Filippo. - In: CANCERS. - ISSN 2072-6694. - STAMPA. - 13:(2021), pp. 2839.1-2839.15. [10.3390/cancers13112839]

TremelImumab and Durvalumab Combination for the Non-OperatIve Management (NOM) of Microsatellite InstabiliTY (MSI)-High Resectable Gastric or Gastroesophageal Junction Cancer: The Multicentre, Single-Arm, Multi-Cohort, Phase II INFINITY Study

Antonuzzo, Lorenzo;
2021

Abstract

In resectable gastric or gastroesophageal junction cancer (GC/GEJC), the powerful positive prognostic effect and the potential predictive value for a lack of benefit from the combination of adjuvant/peri-operative chemotherapy for the MSI-high status was demonstrated. Given the high sensitivity of MSI-high tumors for immunotherapy, exploratory trials showed that combination immunotherapy induces a high rate of complete pathological response (pCR), potentially achieving cancer cure without surgery. INFINITY is an ongoing phase II, multicentre, single-arm, multi-cohort trial investigating the activity and safety of tremelimumab and durvalumab as neoadjuvant (Cohort 1) or potentially definitive (Cohort 2) treatment for MSI-high/dMMR/EBV-negative, resectable GC/GEJC. About 310 patients will be pre-screened, to enroll a total of 31 patients, 18 and 13 in Cohort 1 and 2, at 25 Italian Centres. The primary endpoint of Cohort 1 is rate of pCR (ypT0N0) and negative ctDNA after neoadjuvant immunotherapy, of Cohort 2 is 2-year complete response rate, defined as absence of macroscopic or microscopic residual disease (locally/regionally/distantly) at radiological examinations, tissue and liquid biopsy, during non-operative management without salvage gastrectomy. The ongoing INFINITY proof-of-concept study may provide evidence on immunotherapy and the potential omission of surgery in localized/locally advanced GC/GEJC patients selected for dMMR/MSI-high status eligible for radical resection.
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Raimondi, Alessandra; Palermo, Federica; Prisciandaro, Michele; Aglietta, Massimo; Antonuzzo, Lorenzo; Aprile, Giuseppe; Berardi, Rossana; Cardellino, Giovanni G; De Manzoni, Giovanni; De Vita, Ferdinando; Di Maio, Massimo; Fornaro, Lorenzo; Frassineti, Giovanni L; Granetto, Cristina; Iachetta, Francesco; Lonardi, Sara; Murialdo, Roberto; Ongaro, Elena; Pucci, Francesca; Ratti, Margherita; Silvestris, Nicola; Smiroldo, Valeria; Spallanzani, Andrea; Strippoli, Antonia; Tamberi, Stefano; Tamburini, Emiliano; Zaniboni, Alberto; Di Bartolomeo, Maria; Cremolini, Chiara; Sposito, Carlo; Mazzaferro, Vincenzo; Pietrantonio, Filippo
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2158/1287008
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