On June 2, 2026 Eli Lilly and Company (NYSE: LLY) reported the details of presentations at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting, taking place June 11-14 in Stockholm, Sweden.

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Data to be highlighted include an oral presentation detailing results from the Phase 3 BRUIN CLL-322 study of Jaypirca (pirtobrutinib), a non-covalent Bruton tyrosine kinase (BTK) inhibitor, as part of a time-limited regimen for patients with previously treated chronic lymphocytic leukemia (CLL). Lilly is strengthening its hematology portfolio through the recently announced proposed acquisitions of Ajax Therapeutics, Inc.* and Kelonia Therapeutics, Inc.*, each of which will present data at the meeting. Ajax Therapeutics will present the first clinical data from the Phase 1 AJX-101 study evaluating AJ1-11095, an investigational first-in-class type II JAK2 inhibitor, in patients with myelofibrosis who have been failed by a type I JAK2 inhibitor. Kelonia Therapeutics will present additional correlative data from the Phase 1 inMMyCAR study of an investigational anti-B-cell maturation antigen (BCMA) targeted in vivo CAR-T therapy in patients with relapsed and refractory multiple myeloma. Both proposed acquisitions by Lilly are pending transaction closes.

"These data at EHA (Free EHA Whitepaper) represent a significant moment for Lilly’s hematology ambitions," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. "The Phase 3 BRUIN CLL-322 results address an important question for patients with relapsed or refractory CLL, demonstrating that time-limited pirtobrutinib can meaningfully improve outcomes when added to an already effective venetoclax-based regimen. Alongside the first clinical data from Ajax and additional results from Kelonia in support of the recently presented data at ASCO (Free ASCO Whitepaper), these results reflect our relentless commitment to pursue meaningful advancements for people living with blood disorders."

Presentation Highlights:

Lilly:

In a late-breaking oral presentation, Lilly will share results from the Phase 3 BRUIN CLL-322 study, evaluating a time-limited regimen of pirtobrutinib plus venetoclax and rituximab versus venetoclax and rituximab in patients with relapsed or refractory CLL/SLL. BRUIN CLL-322 is the first Phase 3 readout in CLL to outperform a venetoclax-containing control arm in any CLL setting. Lilly previously announced that the study met its primary endpoint, demonstrating that the addition of pirtobrutinib to venetoclax plus rituximab led to a statistically significant and clinically meaningful improvement in progression-free survival (PFS). These results were also selected to be featured in the EHA (Free EHA Whitepaper) press program.
Ajax Therapeutics:

In an oral presentation, Ajax will share the first clinical results from the Phase 1 AJX-101 clinical trial, evaluating AJ1-11095, an investigational first-in-class type II JAK2 inhibitor, in patients with myelofibrosis who have been failed by a type I JAK2 inhibitor. These data will also be featured in the EHA (Free EHA Whitepaper) press program.
Kelonia Therapeutics:

In an oral presentation, Kelonia will share additional correlative data from the Phase 1 inMMyCAR dose-escalation study, evaluating KLN-1010 in relapsed or refractory multiple myeloma. Data from this study were recently shared at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
A full list of abstract titles and viewing details are listed below:

Abstract Title

Author

Presentation Type/#

Session Title

Session Date/Time (CEST)

Jaypirca (pirtobrutinib; non-covalent BTK inhibitor)

Fixed-duration pirtobrutinib plus venetoclax–rituximab versus venetoclax–rituximab for patients with previously treated CLL/SLL: A phase 3, randomized study (BRUIN CLL-322)

Matthew Davids

Oral

#LB5001

Late-breaking oral session

Sunday, June 14

9:15 – 10:45

Pirtobrutinib in treatment-naïve patients with CLL/SLL: Pooled results from BRUIN CLL-313 and BRUIN CLL-314

Jennifer Woyach

Poster

#PS1701

Chronic lymphocytic leukemia and related disorders – Clinical

Saturday, June 13

18:45 – 19:45

Patient-reported outcomes of pirtobrutinib vs. bendaR in untreated CLL/SLL: Findings from BRUIN-CLL-313 Phase 3 study

Tomasz Wrobel

Poster

#PF1386

Quality of life, ethics, supportive and palliative care

Friday, June 12

18:45 – 19:45

Investigator Initiated

A Phase 2 study of fixed-duration pirtobrutinib and obinutuzumab in previously untreated CLL

Inhye E. Ann

Oral Session

#S148

Prognostication and first line therapy in CLL

Friday, June 12

18:00 – 18:15

AJ1-11095 (Ajax’s investigational first-in-class type II JAK2 inhibitor)

Results of AJX-101, a Phase 1 clinical trial of the type II JAK2 inhibitor AJ1-11095, in patients with myelofibrosis who have been failed by a type I JAK2 inhibitor

John Mascarehas

Oral Session

#S218

Myeloproliferative neoplasms – Clinical

Saturday, June 13

18:00 – 18:15

KLN-1010 (Kelonia’s investigational in vivo CAR-T therapy)

Successful in vivo CAR-T generation and minimal residual disease (MRD) clearance with KLN-1010 across diverse baseline T Cell phenotypes in relapsed/refractory multiple myeloma (RRMM)

Andrew Spencer

Oral Session

#S185

T cell redirected therapy in multiple myeloma

Thursday, June 11

16:45 – 17:00

For more information on Lilly’s oncology pipeline click here.

*Lilly and Ajax Therapeutics, Inc., and Lilly and Kelonia Therapeutics, Inc., remain separate, independent companies prior to closing. Both transactions are subject to customary closing conditions, including regulatory approvals, with Ajax Therapeutics expected to close in June 2026 and Kelonia Therapeutics expected to close in the second half of 2026.

About Jaypirca (pirtobrutinib)
Jaypirca (pirtobrutinib) (pronounced jay-pihr-kaa) is a highly selective (300 times more selective for BTK versus 98% of other kinases tested in preclinical studies), non-covalent inhibitor of the enzyme BTK.1 BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).2,3 Jaypirca is a U.S. FDA-approved oral prescription medicine, 100 mg or 50 mg tablets taken as a once-daily 200 mg dose with or without food until disease progression or unacceptable toxicity.

INDICATIONS FOR JAYPIRCA (pirtobrutinib)
Jaypirca is indicated for the treatment of

Adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor.
Adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
IMPORTANT SAFETY INFORMATION FOR JAYPIRCA (pirtobrutinib)

Infections: Fatal and serious infections (including bacterial, viral, fungal) and opportunistic infections occurred in Jaypirca-treated patients. Across clinical trials, Grade ≥3 infections occurred (25%), most commonly pneumonia (20%); fatal infections (5%), sepsis (6%), and febrile neutropenia (3.8%) occurred. In patients with CLL/SLL, Grade ≥3 infections occurred (32%), with fatal infections occurring in 8%. Opportunistic infections included Pneumocystis jirovecii pneumonia and fungal infection. Consider prophylaxis, including vaccinations and antimicrobial prophylaxis, in patients at increased risk for infection, including opportunistic infections. Monitor for signs and symptoms, evaluate, and treat. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.

Hemorrhage: Fatal and serious hemorrhage has occurred with Jaypirca. Across clinical trials, major hemorrhage (Grade ≥3 bleeding or any central nervous system bleeding) occurred (2.6%), including gastrointestinal hemorrhage; fatal hemorrhage occurred (0.3%). Bleeding of any grade, excluding bruising and petechiae, occurred (16%). Major hemorrhage occurred when taking Jaypirca with (2.0%) and without (0.6%) antithrombotic agents. Consider risks/benefits of co-administering antithrombotic agents with Jaypirca. Monitor for signs of bleeding. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca. Consider withholding Jaypirca 3-7 days pre- and post-surgery based on surgery type and bleeding risk.

Cytopenias: Jaypirca can cause cytopenias, including neutropenia, thrombocytopenia, and anemia. Across clinical trials, Grade 3 or 4 cytopenias, including decreased neutrophils (27%), decreased platelets (13%), and decreased hemoglobin (11%), developed. Grade 4 decreased neutrophils (15%) and Grade 4 decreased platelets (6%) developed. Monitor complete blood counts regularly. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.

Cardiac Arrhythmias: Cardiac arrhythmias occurred in patients taking Jaypirca. Across clinical trials, atrial fibrillation or flutter were reported in 3.4% of Jaypirca treated patients, with Grade 3 or 4 atrial fibrillation or flutter in 1.6%. Other serious cardiac arrhythmias such as supraventricular tachycardia and cardiac arrest occurred (0.4%). Cardiac risk factors such as hypertension or previous arrhythmias may increase risk. Monitor and manage signs and symptoms of arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea). Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.

Second Primary Malignancies: Across clinical trials, second primary malignancies, including non-skin carcinomas, developed in 9% of Jaypirca-treated patients, most frequently non-melanoma skin cancer (4.4%). Other second primary malignancies included solid tumors (including genitourinary and breast cancers) and melanoma. Advise patients to use sun protection and monitor for development of second primary malignancies.

Hepatotoxicity, Including Drug-Induced Liver Injury (DILI): Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of DILI, has occurred in patients treated with BTK inhibitors, including Jaypirca. Evaluate bilirubin and transaminases at baseline and throughout Jaypirca treatment. For patients who develop abnormal liver tests after Jaypirca, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold Jaypirca. If DILI is confirmed, discontinue Jaypirca.

Embryo-Fetal Toxicity: Jaypirca can cause fetal harm. Administration of pirtobrutinib to pregnant rats caused embryo-fetal toxicity, including embryo-fetal mortality and malformations at maternal exposures (AUC) approximately 3-times the recommended 200 mg/day dose. Advise pregnant women of fetal risk and females of reproductive potential to use effective contraception during treatment and for one week after last dose.

Adverse Reactions (ARs) in Patients Who Received Jaypirca

The most common (≥30%) ARs in the pooled safety population of patients with hematologic malignancies (n=704) were decreased neutrophil count (54%), decreased hemoglobin (43%), decreased leukocytes (32%), fatigue (31%), decreased platelets (31%), decreased lymphocyte count (31%), calcium decreased (30%).

Mantle Cell Lymphoma

Serious ARs occurred in 38% of patients, with pneumonia (14%), COVID-19 (4.7%), musculoskeletal pain (3.9%), hemorrhage (2.3%), pleural effusion (2.3%), and sepsis (2.3%) occurring in ≥2% of patients. Fatal ARs within 28 days of last dose occurred in 7% of patients, most commonly due to infections (4.7%), including COVID-19 (3.1% of all patients).

Dose Modifications and Discontinuations Due to ARs: Dose reductions in 4.7%, treatment interruption in 32%, and permanent discontinuation of Jaypirca in 9% of patients. Permanent discontinuation in >1% of patients included pneumonia.

Most common ARs (≥15%) and Select Laboratory Abnormalities (≥10%) (all Grades %; Grade 3-4 %): hemoglobin decreased (42; 9), platelet count decreased (39; 14), neutrophil count decreased (36; 16), lymphocyte count decreased (32; 15), creatinine increased (30; 1.6), fatigue (29; 1.6), musculoskeletal pain (27; 3.9), calcium decreased (19; 1.6), diarrhea (19; -), edema (18; 0.8), dyspnea (17; 2.3), AST increased (17; 1.6), pneumonia (16; 14), bruising (16; -), potassium decreased (13; 1.6), sodium decreased (13; -), lipase increased (12; 4.4), ALT increased (11; 1.6), potassium increased (11; 0.8), alkaline phosphatase increased (11; -). Grade 4 laboratory abnormalities in >5% of patients included neutrophils decreased (10), platelets decreased (7), lymphocytes decreased (6).

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma from Single-Arm and Randomized Controlled Clinical Trials

Serious ARs occurred in 47-56% of patients across clinical trials. Serious ARs in ≥5% of patients in the single-arm trial were pneumonia (18%), COVID-19 (9%), sepsis (7%), febrile neutropenia (7%). Serious ARs in ≥3% of patients in the randomized controlled trial were pneumonia (21%), COVID-19 (5%), sepsis (3.4%). Fatal ARs within 28-30 days of last Jaypirca dose occurred in 8-11% of patients, most commonly due to infections (7-10%), including sepsis (5%), COVID-19 (2.7-5%), and pneumonia (3.4%).

Dose Modifications and Discontinuations Due to ARs: Dose reductions in 3.6-10%, treatment interruption in 42-51%, and permanent discontinuation of Jaypirca in 9-17% of patients. Permanent discontinuation in >1% of patients included second primary malignancy, pneumonia, COVID-19, neutropenia, sepsis, anemia, and cardiac arrhythmias.

Most common ARs and Select Laboratory Abnormalities (≥20%) (all Grades %, Grade 3-4 %)–in a randomized controlled trial: neutrophil count decreased (54; 26), hemoglobin decreased (45; 10), platelet count decreased (37; 17), pneumonia (28; 16), ALT increased (25; 1.8), creatinine increased (25; -), calcium decreased (23; 0.9), sodium decreased (22; 0.9), bilirubin increased (21; 0.9), upper respiratory tract infections (21; 0.9); in a single-arm trial: neutrophil count decreased (63; 45), hemoglobin decreased (48; 19), calcium decreased (40; 2.8), fatigue (36; 2.7), bruising (36; -), cough (33; -), musculoskeletal pain (32; 0.9), platelet count decreased (30; 15), sodium decreased (30; -), COVID-19 (28; 7), pneumonia (27; 16), diarrhea (26; -), abdominal pain (25; 2.7), lymphocyte count decreased (23; 8), ALT increased (23; 2.8), AST increased (23; 1.9), creatinine increased (23; -), dyspnea (22; 2.7), hemorrhage (22; 2.7), lipase increased (21; 7), alkaline phosphatase increased (21; -), edema (21; -), nausea (21; -), pyrexia (20; 2.7), headache (20; 0.9). Grade 4 laboratory abnormalities in >5% of patients included neutrophils decreased (23).

Drug Interactions

Strong CYP3A Inhibitors: Concomitant use increased pirtobrutinib systemic exposure, which may increase risk of Jaypirca ARs. Avoid using strong CYP3A inhibitors with Jaypirca. If concomitant use is unavoidable, reduce Jaypirca dose according to approved labeling.

Strong or Moderate CYP3A Inducers: Concomitant use decreased pirtobrutinib systemic exposure, which may reduce Jaypirca efficacy. Avoid using Jaypirca with strong or moderate CYP3A inducers. If concomitant use with moderate CYP3A inducers is unavoidable, increase Jaypirca dose according to approved labeling.

Sensitive CYP2C8, CYP2C19, CYP3A, P-gp, or BCRP Substrates: Use with Jaypirca increased their plasma concentrations, which may increase risk of ARs related to these substrates for drugs sensitive to minimal concentration changes. Follow recommendations for these sensitive substrates in their approved labeling.

Use in Specific Populations

Pregnancy and Lactation: Due to potential for Jaypirca to cause fetal harm, verify pregnancy status in females of reproductive potential prior to starting Jaypirca. Presence of pirtobrutinib in human milk is unknown. Advise women to use effective contraception and to not breastfeed while taking Jaypirca and for one week after last dose.

Geriatric Use: In the pooled safety population of patients with hematologic malignancies, patients aged ≥65 years experienced higher rates of Grade ≥3 ARs and serious ARs compared to patients <65 years of age.

Renal Impairment: Because severe renal impairment increases pirtobrutinib exposure, reduce Jaypirca dose in these patients according to approved labeling.

(Press release, Eli Lilly, JUN 2, 2026, View Source [SID1234666365])

On June 2, 2026 AbbVie (NYSE: ABBV) reported it will participate in the Goldman Sachs 47th Annual Global Healthcare Conference on Tuesday, June 9, 2026. Management will participate in a fireside chat at 9:40 a.m. Central time.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

(Press release, AbbVie, JUN 2, 2026, View Source [SID1234666381])

On June 2, 2026 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, reported positive results from CRDF-004, a randomized, controlled, dose-finding Phase 2 clinical trial evaluating onvansertib in combination with SoC regimens (FOLFIRI/bevacizumab (bev) or FOLFOX/bev) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). Results showed that the selected dose/regimen of the registrational program, onvansertib 30 mg + FOLFIRI/bev, demonstrated deep and durable tumor shrinkage, including clinically meaningful improvements in overall response rate (ORR) and progression-free survival (PFS) compared to SoC alone, with no additive adverse events. The data were presented today by Heinz-Josef Lenz, MD, associate director for clinical research and co-leader of the GI cancers program at the University of Southern California (USC) Norris Comprehensive Cancer Center, in a rapid oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago.

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Following the completion of the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), the Company has aligned on the design of the registrational trial with onvansertib in mCRC. The randomized, controlled Phase 3 trial will evaluate the safety and efficacy of onvansertib 30 mg + FOLFIRI/bev as first-line therapy versus standard-of-care FOLFIRI/bev in patients with RAS-mutated mCRC.

"RAS-mutated metastatic colorectal cancer remains a significant clinical challenge, with limited therapeutic progress over the past two decades. Patients with RAS-mutated mCRC continue to face poor outcomes, and there are currently no treatment options specifically approved for patients with RAS-mutated mCRC—except for KRAS G12C mutations, which account for less than 4% of all colorectal cancers," said Dr. Lenz. "With its novel mechanism of action, onvansertib, when combined with FOLFIRI/bev, demonstrated deep and durable tumor shrinkage over time. A positive confirmatory Phase 3 study that builds on the Phase 2 data presented today could potentially establish onvansertib + FOLFIRI/bev as a new standard-of-care for these patients."

Data Highlights from the ongoing Phase 2 trial (Data cut: March 18, 2026):
In the intent-to-treat (ITT) population, the dose selected for the registrational program, 30 mg onvansertib arm in combination with FOLFIRI/ bev achieved:

Primary endpoint of confirmed objective response rate of 72.2% (13/18), compared with 42.1% (8/19) for FOLFIRI/bev alone, a 30% improvement over standard-of-care (SoC). The responses were deeper and more durable in the onvansertib arm.
Secondary endpoint of progression free survival (PFS) hazard ratio (HR) of 0.55 (95% CI: 0.15–2.09) and 0.57 (95% CI: 0.20–1.65) vs. FOLFIRI/bev by Blinded Independent Central Review (BICR) and investigator assessment (IA), respectively.
Median PFS not reached in 30 mg onvansertib + FOLFIRI/bev arm, but has been reached in both SoC arms. Four patients remain on onvansertib treatment beyond 15 months, including 2 beyond 20 months.

Notably, fourteen patients remain on trial, with nine patients in the onvansertib (20 or 30 mg) plus FOLFIRI/bev arms and one patient remaining on SoC.

No meaningful differences in efficacy were observed between the onvansertib + FOLFOX/bev arms and FOLFOX/bev alone.

Safety/Tolerability:
Onvansertib in combination with both chemotherapy (FOLFIRI or FOLFOX)/bev regimens was well-tolerated. There were no major or unexpected toxicities observed and no additive adverse events reported. Grade 3 or higher adverse events were infrequent, with neutropenia being the most common treatment-emergent adverse event across both the onvansertib combination and SoC arms.

"We are excited to share these updated results and are highly encouraged by the consistent efficacy seen with onvansertib in combination with FOLFIRI/bev across two clinical trials in patients with RAS-mutated mCRC," said Mani Mohindru, PhD, President and Chief Executive Officer. "The data generated to date continue to support the potential of onvansertib in combination with standard-of-care FOLFIRI/bev in RAS-mutated mCRC and reinforce our plans to advance the program into a global registrational study. We look forward to providing additional updates on those plans in the coming months."

The ASCO (Free ASCO Whitepaper) presentation will be made available on the Scientific Publications page of the Company’s website following the rapid oral presentation.

Conference Call and Webcast
The investor webcast will take place on June 3, 2026 at 8:30 am ET/5:30 am PT. To register for and access the live webcast, please visit the "Events" page of the Cardiff Oncology website. The slides from the conference call will be posted after the call has concluded.

CRDF-004 Trial Design
The CRDF-004 Phase 2 trial was designed to evaluate the safety, efficacy, and pharmacokinetics of two different doses of onvansertib in combination with FOLFIRI/bevacizumab or FOLFOX/bevacizumab in first-line patients with KRAS- or NRAS-mutated metastatic colorectal cancer (mCRC). The randomized, controlled trial was designed to enroll 110 patients across 6 different arms, and the trial’s endpoints include objective response rate (ORR), progression-free survival (PFS), duration of response, and safety.

For additional information about the trial, please visit www.clinicaltrials.gov (Trial ID: NCT06106308).

About Onvansertib
Onvansertib is a highly specific, oral PLK1 inhibitor advancing toward a registrational trial in first-line RAS-mutated metastatic colorectal cancer (mCRC). In a randomized Phase 2 trial, onvansertib in combination with FOLFIRI/bevacizumab (first-line standard-of-care) demonstrated dose-dependent improvements in overall response rate and progression-free survival compared to standard-of-care alone, building on findings from a prior Phase 2 trial in second-line RAS-mutated mCRC. Based on these results, the Company has selected the 30 mg dose of onvansertib in combination with FOLFIRI/bevacizumab for advancement into a registrational trial in first-line patients with RAS-mutated mCRC.

Onvansertib is also being evaluated in multiple other cancers through investigator-initiated studies, including metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and chronic myelomonocytic leukemia (CMML).

(Press release, Cardiff Oncology, JUN 2, 2026, View Source [SID1234666397])

On June 2, 2026 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that its late-breaking abstract was accepted for an oral presentation at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Congress, taking place June 11 to 14 in Stockholm, Sweden. The SENTRY presentation was selected by EHA (Free EHA Whitepaper)’s Scientific Program Committee as one of the six best abstracts to be presented during the Late-Breaking Oral Session on Sunday, June 14th. The oral presentation will feature results from the Phase 3 SENTRY trial, a randomized, double-blind, placebo-controlled trial of 60 mg selinexor in combination with ruxolitinib in myelofibrosis.

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This abstract highlights the combination of selinexor plus ruxolitinib’s ability to enable rapid, deep and sustained spleen volume reductions; similar symptom improvement; a promising signal of overall survival; more patients achieving ≥20% reductions in variant allele frequency (VAF) as early as week 24; and a manageable safety profile. In addition, new data will highlight a post-hoc analysis of 24 patients from the Phase 1 portion of the SENTRY trial which indicates that achieving a spleen volume reduction of 35% or more (SVR35) may predict overall survival, consistent with a similar analysis from the Phase 3 SENTRY trial.

"The SENTRY results are an important development for patients with myelofibrosis, with the combination of selinexor plus ruxolitinib showing a promising overall survival signal supported by rapid, deep and sustained spleen volume reduction and the potential for disease modification with lower levels of VAF," said Dr. Claire Harrison, Professor of Myeloproliferative Neoplasms at Guy’s and St. Thomas’ NHS Foundation Trust in the United Kingdom. "JAK inhibitors have transformed the treatment landscape over the past 15 years, but there remains a significant need for novel therapies that can build upon their foundation and target additional biological pathways driving disease progression. XPO1 inhibition represents a differentiated mechanism with the potential to extend the benefits of therapy beyond JAK inhibition alone, including the potential to extend overall survival which remains the ultimate objective for patients living with myelofibrosis."

"The results from the Phase 1 portion of our SENTRY trial being presented at EHA (Free EHA Whitepaper) provide further support for the promising overall survival signal we saw in our Phase 3 SENTRY results," said Reshma Rangwala, MD, PhD, Chief Medical Officer and Head of Research of Karyopharm. "Collectively, this new analysis, when combined with our existing landmark analysis, provides evidence that supports our belief that SVR35 can be used to predict overall survival. This is incredibly exciting in light of the rapid, deep and sustained reduction in spleen volume observed with selinexor plus ruxolitinib, with the combination approximately doubling the proportion of patients achieving SVR35 as early as week 12 and sustained through week 36. We believe this is driven by selinexor’s differentiated mechanism of action which offers a complementary and potentially synergistic approach to JAK inhibition."

Presentation Details

Title: Selinexor plus ruxolitinib in Janus kinase inhibitor–naïve myelofibrosis: Phase 3 SENTRY trial

Abstract Code: LB5002

Session Title: Late-Breaking Oral Session

Presentation Time: Sunday, June 14, 2026, 9:15 a.m. to 10:45 a.m. Central European Summer Time

Presenter: Dr. Claire Harrison, Professor of Myeloproliferative Neoplasms, Clinical Director at Guy’s and St. Thomas’ NHS Foundation Trust
A copy of the SENTRY presentation to be presented at EHA (Free EHA Whitepaper) will be available on the Company’s investor relations website under "Publications and Presentations" on June 14, 2026. The peer-reviewed publication discussing the results from the Phase 3 SENTRY trial was published this morning in the Journal of Clinical Oncology and is available on JCO’s website.

About the Phase 3 SENTRY Trial

SENTRY (XPORT-MF-034; NCT04562389) is a Phase 3 clinical trial evaluating a once-weekly dose of 60 mg of selinexor in combination with ruxolitinib compared to placebo plus ruxolitinib in JAKi-naïve myelofibrosis patients with platelet counts >100 x 109/L (N=353). Patients were randomized 2-to-1 to the selinexor arm. The co-primary endpoints for this trial are spleen volume reduction ≥ 35% (SVR35) at week 24 and the average change in absolute total symptom score (Abs-TSS) over 24 weeks relative to baseline.

About Myelofibrosis

Myelofibrosis is a rare blood cancer that affects approximately 20,000 patients in the United States and 17,000 patients in the European Union1. The disease causes bone marrow fibrosis (scarring in the bone marrow), which makes it difficult for the bone marrow to make healthy blood cells, splenomegaly (enlarged spleen), progressive anemia which often leads to symptoms like fatigue and weakness, and other disease associated symptoms including abdominal discomfort, pain under the left ribs, early satiety, night sweats and bone pain. The only approved class of therapies to treat myelofibrosis are JAK inhibitors, including ruxolitinib.

1. Clarivate/DRG (2023)

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral exportin 1 (XPO1) inhibitor compound for the treatment of cancer. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein XPO1. XPOVIO is approved and marketed by Karyopharm in the U.S. in multiple oncology indications, including: (i) in combination with VELCADE (bortezomib) and dexamethasone (XVd) in adult patients with multiple myeloma after at least one prior therapy; and (ii) in combination with dexamethasone in adult patients with heavily pre-treated multiple myeloma. XPOVIO (also known as NEXPOVIO in certain countries) has received regulatory approvals in various indications in a growing number of ex-U.S. territories and countries, including but not limited to the European Union, the United Kingdom, Mainland China, Taiwan, Hong Kong, Australia, South Korea, Singapore, Israel, and Canada. XPOVIO/NEXPOVIO is marketed in these respective ex-U.S. territories by Karyopharm’s partners: Antengene, Menarini, Neopharm, and FORUS. Selinexor is also being investigated in several other mid- and late-stage clinical trials across multiple high unmet need cancer indications, including in myelofibrosis and endometrial cancer.

For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at: Tel: +1 (888) 209-9326; Email: [email protected]

XPOVIO (selinexor) is a prescription medicine approved:

In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (XVd).

In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti‐CD38 monoclonal antibody (Xd).
SELECT IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Thrombocytopenia: Monitor platelet counts throughout treatment. Manage with dose interruption and/or reduction and supportive care.
Neutropenia: Monitor neutrophil counts throughout treatment. Manage with dose interruption and/or reduction and granulocyte colony‐stimulating factors.
Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia, and weight loss may occur. Provide antiemetic prophylaxis. Manage with dose interruption and/or reduction, antiemetics, and supportive care.
Hyponatremia: Monitor serum sodium levels throughout treatment. Correct for concurrent hyperglycemia and high serum paraprotein levels. Manage with dose interruption, reduction, or discontinuation, and supportive care.
Serious Infection: Monitor for infection and treat promptly.
Neurological Toxicity: Advise patients to refrain from driving and engaging in hazardous occupations or activities until neurological toxicity resolves. Optimize hydration status and concomitant medications to avoid dizziness or mental status changes.
Embryo‐Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception.
Cataract: Cataracts may develop or progress. Treatment of cataracts usually requires surgical removal of the cataract.
Adverse Reactions

The most common adverse reactions (≥20%) in patients with multiple myeloma who receive XVd are fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract and vomiting. Grade 3‐4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia and neutropenia. In the BOSTON trial, fatal adverse reactions occurred in 6% of patients within 30 days of last treatment. Serious adverse reactions occurred in 52% of patients. Treatment discontinuation rate due to adverse reactions was 19%.

The most common adverse reactions (≥20%) in patients with multiple myeloma who receive Xd are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea and upper respiratory tract infection. In the STORM trial, fatal adverse reactions occurred in 9% of patients. Serious adverse reactions occurred in 58% of patients. Treatment discontinuation rate due to adverse reactions was 27%.
Use In Specific Populations
Lactation: Advise not to breastfeed.

For additional product information, including full prescribing information, please visit www.XPOVIO.com.

To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1‐888‐209‐9326 or FDA at 1‐800‐FDA‐1088 or www.fda.gov/medwatch.

(Press release, Karyopharm, JUN 2, 2026, View Source [SID1234666366])

On June 2, 2026 Evogene Ltd. ("Evogene") (Nasdaq: EVGN) (TASE: EVGN), a pioneering computational chemistry company specializing in generative design of small molecules for the pharmaceutical and agricultural industries, reported the successful completion of the first-in-human (FIH) Phase 1 clinical study of BMC128, a rationally-designed live bacterial product developed by its subsidiary, Biomica Ltd., in combination with Nivolumab in patients with advanced solid tumors, including melanoma, renal cell carcinoma (RCC), and non-small cell lung cancer (NSCLC).

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The open-label, single-arm Phase 1 study enrolled 11 patients, with advanced solid tumors who had previously progressed following anti-PD-1 immunotherapy and was designed to evaluate the safety and tolerability of BMC128 in combination with Nivolumab. The treatment regimen included a two-week induction phase with BMC128 monotherapy, followed by 16 weeks of combination treatment with BMC128 and Nivolumab. Patients demonstrating clinical benefit were eligible to continue Nivolumab monotherapy for up to two years or until disease progression.

The study successfully met its primary endpoint, demonstrating favorable safety and tolerability, with no dose-limiting toxicities observed.

Preliminary clinical findings demonstrated early signs of anti-tumor activity. Five of the eleven treated patients achieved stable disease beyond the 16-week combination treatment period. Two patients remained on study through the full two-year follow-up period during Nivolumab maintenance therapy, while one patient achieved a partial response.

In addition to clinical observations, translational analyses demonstrated biological signals consistent with the proposed mechanism of action of BMC128. Responding patients showed increased microbiome diversity, evidence of immune activation, and modulation of immune suppression-associated signatures.

Ofer Haviv, President and CEO of Evogene and Biomica, commented:
"Completion of this first-in-human study represents an important milestone for the BMC128 development program and further supports the potential of microbiome-based approaches in immuno-oncology. We are encouraged not only by the favorable safety and tolerability profile observed in the study, but mainly by the preliminary signals of clinical activity and the translational data supporting the proposed mechanism of action of BMC128. We believe these findings support the continued clinical development of BMC128 by our licensing partner, Lishan Biotech."

Earlier this year, Evogene, through its subsidiary Biomica, entered into a licensing agreement with Lishan Biotech for the continued clinical development and commercialization of BMC128, now designated LS-LBP-002.

Dr. Weijie Chen, President and CEO of Lishan Biotech, added: "We are highly encouraged by the favorable safety profile and preliminary efficacy signals results generated in this Phase 1 study. These results not only provide important support for the continued advancement of LS-LBP-002, formerly BMC128, but also strengthen our confidence in the rationale of rationally designed live bacterial products combined with immune checkpoint inhibitors.

Based on this positive data, we are accelerating our planning for the next-stage clinical development. We look forward to further evaluating the therapeutic potential of this novel microbiome-based approach and bringing this promising candidate closer to patients in need."

About BMC128

BMC128 is a rationally designed live bacterial therapeutic candidate developed to facilitate anti-tumor immune responses in patients receiving immune checkpoint inhibitors. The product consists of a defined consortium of bacterial strains selected based on Evogene’s computational microbiome discovery platform and preclinical validation studies.

Under the licensing agreement with Lishan Biotech, BMC128 is being further developed under the designation LS-LBP-002.

(Press release, Evogene, JUN 2, 2026, View Source [SID1234666382])