OnCo
trialsTrialPositive

PhALLCON

Head to head, the third-generation TKI ponatinib doubled the rate of deep, undetectable remission over imatinib in newly diagnosed Ph-positive ALL.

MRD-negative CR at end of induction 34.4% vs 16.7% (risk difference 0.18, p=0.002); fewer treatment failures; arterial occlusive events comparable at the reduced 30→15 mg dosing. JAMA 2024. Accelerated approval March 2024; the first randomised TKI comparison in frontline Ph+ ALL.

Setting
Newly diagnosed Ph-positive ALL, adults: ponatinib vs imatinib, each with reduced-intensity chemotherapy
Phase
Phase 3
Sponsor
Takeda
Registry
Headline result
MRD-negative CR 34.4% vs 16.7%.
Reported
2024
Enrolled
245
Replication
Single-arm hyper-CVAD + ponatinib series (MD Anderson) report 5-year OS ~75%; GIMEMA and GRAAPH studies with dasatinib/nilotinib show lower molecular response rates, consistent with a class-potency effect.

Outcomes

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In plain words
What these results mean for people, not percentages
245 people took part
MRD-negative complete remission at end of inductionprimarysurrogate endpoint
  • 34.4 vs 16.7 out of 100 had no detectable disease on sensitive tests with Ponatinib + chemotherapy compared with Imatinib + chemotherapy; 17.7 more per 100.
  • Roughly one extra person helped for every 6 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
  • The p-value (0.002) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
  • This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
  • These results apply to the people the trial enrolled: Newly diagnosed Ph-positive ALL, adults: ponatinib vs imatinib, each with reduced-intensity chemotherapy. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

245 participants enrolled.

MRD-negative complete remission at end of inductionprimary
· p = 0.002
Ponatinib + chemotherapy34.4 of 100
n = 164
Imatinib + chemotherapy16.7 of 100
n = 81
Source
EndpointArmnValueHR (95% CI)pSource
MRD-negative complete remission at end of inductionprimaryPonatinib + chemotherapy16434.4%0.002link
Imatinib + chemotherapy8116.7%
Replication
Single-arm hyper-CVAD + ponatinib series (MD Anderson) report 5-year OS ~75%; GIMEMA and GRAAPH studies with dasatinib/nilotinib show lower molecular response rates, consistent with a class-potency effect.

Connected

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