# Gimema All2820 phase 3: ponatinib plus blinatumomab without chemotherapy gave 86% two-year event-free survival

- Published: 2026-11-10 23:58 UTC
- Section: Life & Health › Medicine
- Tags: Gimema All2820, ponatinib, blinatumomab, chemotherapy-free regimen, event-free survival, molecular response, tyrosine kinase inhibitor, Sapienza University of Rome
- URL: https://realtech.media/news/rt-ec4c4fe2d17f1e38302eb025_gimema_all2820_phase/

**In 236 adults with newly diagnosed Ph+ acute lymphoblastic leukemia, a chemotherapy-free regimen was compared with imatinib plus chemotherapy. The phase 3 results were published in NEJM.**

![Gimema All2820 phase 3: ponatinib plus blinatumomab without chemotherapy gave 86% two-year event-free survival](https://realtech.media/media/2026/11/93ffb7a5caa031bd.jpg)
*Brandon9993, Wikimedia Commons, CC BY-SA 4.0*

The Gimema All2820 phase 3 trial compared a chemotherapy-free regimen with standard treatment in adults with newly diagnosed Philadelphia-positive acute lymphoblastic leukemia (Ph+ ALL). The results were published in the New England Journal of Medicine, according to a statement reported by adnkronos.com [1]. The trial was coordinated by Sabina Chiaretti and Robin Foà of Sapienza University of Rome and sponsored by Fondazione Gimema – Franco Mandelli Ets [1].

## Trial design

From September 2021 to January 2025, the trial enrolled 236 adults aged 24 to 82 [1]. A total of 158 patients received the experimental regimen and 78 received standard treatment [1]. The experimental arm received the third-generation tyrosine kinase inhibitor ponatinib, followed by 2 to 5 intravenous cycles of the bispecific antibody blinatumomab [1]. The standard arm received the inhibitor imatinib with chemotherapy [1].

The primary endpoint was event-free survival. It accounts for survival, hematologic response, persistence of disease at the molecular level and events such as relapse [1]. Molecular response, which detects very small amounts of residual disease, received particular attention [1].

## Reported results

At two years, 86% of patients on ponatinib and blinatumomab had had no adverse event, compared with 67% on standard treatment [1]. After induction, 94% of the experimental group had reached complete hematologic remission, versus 79% in the standard group [1]. After consolidation with blinatumomab, molecular response was reached by 71% of patients treated without chemotherapy and 49% of those on the standard regimen [1].

Two-year overall survival was 90% in the experimental group and 85% in the standard group [1]. The cumulative probability of relapse was 5% and 13%, respectively [1]. The statement also says the regimen reduced side effects [1].

## Background

Ph+ ALL is caused by a chromosomal translocation that fuses the BCR and ABL1 genes. The resulting fusion protein promotes uncontrolled cell proliferation [1]. For a long time, chemotherapy and allogeneic hematopoietic stem cell transplantation were the mainstays of treatment, and tyrosine kinase inhibitors have been used since the early 2000s [1]. In 2000 the Gimema group started the Lal0201 study, one of the first protocols using imatinib without chemotherapy during induction [1]. Later Gimema studies explored first-, second- and third-generation inhibitors [1].

Foà said the study provides solid evidence for a possible change of paradigm in treating adult Ph+ ALL [1].

## Sources

1. [adnkronos.com](https://www.adnkronos.com/cronaca/tumori-leucemia-linfoblastica-acuta-ph-delladulto-nuovo-standard-di-cura-senza-chemio_7tTckJ3kGZD97iGgdq4E2i)

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Source: RealTech, realtech.media — https://realtech.media/news/rt-ec4c4fe2d17f1e38302eb025_gimema_all2820_phase/