Lilly Spotlight Growing Hematology Portfolio at EHA
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Lilly will present positive Phase 3 BRUIN CLL-322 results at the 2026 EHA Annual Meeting, comparing pirtobrutinib plus venetoclax and rituximab against venetoclax and rituximab. The presentation underscores Lilly's expanding hematology portfolio, bolstered by recent acquisitions of Ajax Therapeutics and Kelonia Therapeutics.
Lilly spotlight growing hematology portfolio messaging at EHA 2026 centers on Phase 3 BRUIN CLL-322 for Jaypirca (pirtobrutinib). Detailed results show a 45% cut in progression or death risk (HR 0.55) when pirtobrutinib is added to a time-limited venetoclax–rituximab backbone.
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Key Takeaways
- BRUIN CLL-322 (NCT04965493): HR 0.55 for IRC PFS; 45% risk reduction; p=0.0001.
- 639 patients; 79.8% prior covalent BTKi; median follow-up 27.3 months; median PFS not reached vs 39.7 months.
- EHA 2026 (Stockholm, June 11–14) also features Ajax AJ1-11095 and Kelonia inMMyCAR data.
- Jaypirca already FDA-approved for specified MCL and CLL/SLL uses; confirmatory and label strategy still evolving.
What did Lilly preview for EHA 2026?
On June 2, 2026, Eli Lilly said it would spotlight hematology presentations at the European Hematology Association Annual Meeting in Stockholm, June 11–14, 2026.
The lead item is a late-breaking oral on Phase 3 BRUIN CLL-322: time-limited pirtobrutinib plus venetoclax and rituximab versus venetoclax and rituximab in relapsed or refractory CLL/SLL.
Primary: Lilly EHA 2026 hematology preview — PR Newswire.
How strong is the BRUIN CLL-322 efficacy signal?
On June 14, 2026, Lilly reported detailed results: adding pirtobrutinib cut the risk of progression or death by 45% (HR=0.55; 95% CI 0.40–0.75; p=0.0001) on IRC-assessed PFS.
The trial enrolled 639 patients (PVR n=321; VR n=318). About 79.8% had prior covalent BTK inhibitor exposure. At median follow-up of 27.3 months, median PFS was not reached in the PVR arm versus 39.7 months for VR.
Primary: Jaypirca BRUIN CLL-322 detailed results — PR Newswire.
Where is the confirmatory trial registered?
ClinicalTrials.gov lists the randomized Phase 3 comparison of pirtobrutinib plus venetoclax and rituximab versus venetoclax and rituximab as NCT04965493 (BRUIN CLL-322).
Registry pages are the durable place to track status, arms, and endpoints after conference slides circulate.
Registry: NCT04965493 — BRUIN CLL-322.
What else sits in the EHA hematology package?
Lilly’s June 2 preview also pointed to Ajax Therapeutics’ first clinical data from Phase 1 AJX-101 of AJ1-11095, an investigational type II JAK2 inhibitor, in myelofibrosis after type I JAK2 inhibitor failure.
Kelonia Therapeutics was slated to present additional correlative data from Phase 1 inMMyCAR, an investigational anti-BCMA in vivo CAR-T approach in relapsed/refractory multiple myeloma. As of the June 2 release, both proposed acquisitions were pending close.
A separate June 13, 2026 PR Newswire update later described Ajax acquisition completion and AJX-101 oral data (abstract S218). Treat close status as time-stamped when you cite.
Ajax update: AJ1-11095 EHA data — PR Newswire.
How should teams read Jaypirca’s current U.S. label context?
Lilly’s EHA preview restates that Jaypirca is an FDA-approved oral non-covalent BTK inhibitor dosed at 200 mg once daily (100 mg or 50 mg tablets available). MCL accelerated approval and CLL/SLL labeling details appear in the company’s safety sections of the same release family.
For EU BD workstreams, separate EMA/CHMP status from U.S. label text. Conference PFS wins do not automatically equal same-day label expansion in every region.
FDA drug database entry point: FDA Drugs@FDA data files.
What remains unproven after EHA 2026
Overall survival maturity, regulatory acceptance of the triplet as a new standard, and durability after the two-year time-limited schedule still need longer follow-up. Ajax and Kelonia assets should be modeled as pipeline options with Phase 1 uncertainty, not as commercial hematology revenue.
Avoid vague peer-comparison filler. Stick to HR 0.55, enrollment 639, and registry NCT04965493 when briefing investors.
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Frequently Asked Questions
What is the primary endpoint result from BRUIN CLL-322?
Lilly reported that adding pirtobrutinib to venetoclax plus rituximab reduced the risk of disease progression or death by 45% versus venetoclax plus rituximab alone (HR=0.55; 95% CI 0.40–0.75; p=0.0001) by IRC-assessed PFS.
How many patients did BRUIN CLL-322 enroll?
The Phase 3 study enrolled 639 relapsed or refractory CLL/SLL patients randomized 1:1 to pirtobrutinib plus venetoclax and rituximab (n=321) or venetoclax and rituximab alone (n=318). About 79.8% had prior covalent BTK inhibitor exposure.
What else is in Lilly’s EHA 2026 hematology spotlight?
Besides BRUIN CLL-322, Lilly’s June 2, 2026 EHA preview highlighted Ajax Therapeutics’ Phase 1 AJX-101 type II JAK2 inhibitor AJ1-11095 in myelofibrosis and Kelonia’s Phase 1 inMMyCAR BCMA in vivo CAR-T correlative data in multiple myeloma.
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