Demo·seeded data·not investment advice
BioSight
ReadoutTopline Readout

AYVAKIT PIONEER 2L GIST Phase 3 Topline

BPMC·AYVAKIT·GIST··NCT04695704
current best date
SEP
2026
MONTH4 months
Takeaway

Phase 3 efficacy readout for AYVAKIT in second-line GIST. AYVAKIT is currently approved in PDGFRA D842V-mutant GIST and indolent/advanced systemic mastocytosis. Watch: PFS vs. sunitinib comparator.

What’s at stake

market · comparables · base rate · prior moves
Market opportunity
company filings
Peer comparables
1 readout
ClinicalTrials.gov
Stage base rate
~100%
BIO Industry Analysis 2023 (2011–2020)
Avg prior-readout move
historical price reactions
Drug
small molecule
AYVAKIT
avapritinib · INN
MoAKIT/PDGFRα inhibitor

AYVAKIT (avapritinib) is a highly selective oral kinase inhibitor developed by Blueprint Medicines that targets activating mutations in KIT and PDGFRα — the dominant oncogenic drivers in gastrointestinal stromal tumors (GIST) and systemic mastocytosis. The drug fits precisely into the ATP-binding pocket of these mutant kinases to block the aberrant signaling driving tumor growth and mast cell accumulation. AYVAKIT is approved for PDGFRA Exon 18 D842V-mutant GIST — a subset previously insensitive to imatinib — and for advanced and indolent systemic mastocytosis; Blueprint is studying avapritinib versus sunitinib in second-line GIST in an ongoing Phase 3 trial.

Indication
Oncology - Solid
GIST
MeSH · D046152

No primer in glossary yet.

Trial
active
NCT04695704
PIONEER Phase 3 Avapritinib in 2L GIST
Phase
Ph 3
N
280
Primary completion
Aug 15, 2026
Glossary · what this readout is measuring
1 term detected in the takeaway
  • PFSendpoint
    Progression-Free Survival

    Time from randomization until tumor progression or death. Mid-term oncology endpoint; correlates with overall survival in many tumor types.

Reference data · comparable readouts

How Appr readouts in Oncology - Solid have landed.

Reference, not prediction. We surface the historical record so you can read it yourself. We never extrapolate to the upcoming event.

Positive
0/0
0% in record
Primary endpoint hit
0%
across 0 readouts
Drug · sponsorPhase · yearOutcomeKey metricSource
datopotamab deruxtecan
AZN · NSCLC 2L
Ph3 · Jan 2024mixedPFS hit, OS not stat-sig8-K
tarlatamab
AMGN · SCLC 2L+
Ph2 · Oct 2023positiveORR 40% — first BiTE in SCLCconference
tislelizumab (RATIONALE-303)
BGNE · NSCLC 2L
Ph3 · Apr 2023positiveOS 17.2 vs 11.9 moPR
sotorasib
AMGN · KRAS-G12C NSCLC
Ph3 · Sep 2022mixedPFS hit; OS HR 0.91 (n.s.)conference
enhertu (DESTINY-Breast03)
AZN · HER2+ Breast
Ph3 · Sep 2021positivemPFS 25.1 vs 7.2 moconference
sorted by phase match, then recency · sources span PR wires, CT.gov, FDA notices, and conference presentations · we never editorialize the outcome label

Competitive landscape

1 peer in Oncology - Solid · ranked by indication + modality match
DrugCompanyModalityMechanismPhaseNext catalyst
REC-994RXRXsmall moleculeoxidative stress modulator (CCM)READOUT · Nov 26

Prior BPMC reactions to Readout events

2 historical events · base rate, not prediction
Median 1W move
+2.5%
Median 1M move
-8.3%
Positive outcomes
0/ 2
0%
Negative outcomes
1/ 2
50%
DateHeadlineOutcome1W1M6M
Jan 2026AYVAKIT — Phase 3 Topline — Mixed Resultnegative-14.2%-39.5%-19.4%
Aug 2024AYVAKIT — Phase 2b Topline Met Primary Endpointmixed+19.1%+22.9%+31.5%

Historical BPMC stock reaction to past Readout catalysts. Past performance is not a forecast — base rates anchor expectations, not outcomes. Positive rate 0%.

Disclosure trail

1 observation · sorted by confidence
  1. Mar 25, 2026·1mo agopinned · highest confidence
    HIGH confPR
    top claim
    SEP2026
    MONTH
    PIONEER, the Phase 3 study of AYVAKIT in second-line GIST, is expected to deliver topline data in September 2026.
    conf 89%via llm

MethodologyEvery catalyst date is anchored to a primary source. Disclosures with confidence ≥ 0.85 auto-publish; the rest are reviewed by a human within 24 hours. We never interpret data — we organize public information.

Disclaimer·BioSight aggregates publicly available data (SEC EDGAR, ClinicalTrials.gov, FDA, company press releases) and is provided as is for informational purposes only. Nothing here is investment, financial, legal, tax, or medical advice, or an offer to buy or sell any security. We make no warranty as to accuracy, completeness, or timeliness; dates and filings may contain errors or be superseded without notice; past events do not predict future outcomes. To the maximum extent permitted by law, BioSight, its operators, contributors, and affiliates disclaim all liability for any loss or damage arising from use of or reliance on this site. You are solely responsible for your own investment decisions — consult a licensed professional before acting on any information.

Unlock 12-month calendar