On June 2, 2026 Lantern Pharma presented its corporate presentation.

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(Presentation, Lantern Pharma, JUN 2, 2026, View Source [SID1234666370])

On June 2, 2026 Kura Oncology, Inc. (Nasdaq: KURA, "Kura") and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin") reported the publication in Blood of updated results from the relapsed/refractory (R/R) NPM1-mutated acute myeloid leukemia (NPM1-m AML) cohort of KOMET-007, a Phase 1a/b trial evaluating ziftomenib in combination with venetoclax and azacitidine (ven/aza). The publication reports nearly two-thirds of patients experienced clinically meaningful, deep and durable responses with a well-tolerated safety profile in adults with R/R NPM1-m AML.

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KOMZIFTI (ziftomenib) is approved by the U.S. Food and Drug Administration as monotherapy for adult patients with relapsed or refractory AML with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. Ziftomenib in combination with ven/aza is investigational and has not been approved by the FDA.

"This analysis provides a more mature evaluation of ziftomenib in combination with venetoclax and azacitidine in patients with NPM1-mutated AML," said Eunice S. Wang, M.D., Chief of Leukemia, Roswell Park Comprehensive Cancer Center, and co-first senior author of the publication. "In the relapsed/refractory setting, outcomes with venetoclax-based regimens in patients with NPM1-mutant AML remain suboptimal, highlighting the substantial need for more effective therapies. These KOMET-007 results are notable for the depth and durability of response observed with the investigational three-drug combination. The favorable safety profile also supports the continued evaluation of this combination in a setting where better treatment options are urgently needed."

"As combination approaches become increasingly important in this setting, the data highlighted in this publication strengthen the case for ziftomenib as a backbone in NPM1-mutant AML," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "Ziftomenib combined with ven/aza demonstrated deep molecular responses, durable remissions, and a generally manageable safety profile in R/R NPM1-m AML. These findings support our ongoing efforts to evaluate ziftomenib-based combinations across the treatment continuum, including in randomized studies designed to define the potential of ziftomenib in newly diagnosed disease."

KOMET-007 Results in R/R NPM1-m AML

The data include 64 response-evaluable patients with R/R NPM1-m AML from the ongoing KOMET-007 Phase 1a/b trial (NCT05735184), 27 of whom were treated in phase 1a dose escalation and 37 of whom were treated in phase 1b expansion, as of the January 16, 2026 data cutoff date. Patients had received 1 to 8 prior lines of therapy (median of 1), and 37 patients (55%) had prior venetoclax exposure.

Robust clinical activity was observed in patients with R/R NPM1-m AML across all ziftomenib dose levels, with nearly two-thirds of all patients experiencing clinically meaningful, deep, and durable responses. In addition, rapid responses were observed, with a median time to composite complete remission (CRc) of 3.9 weeks.

Venetoclax-Naïve Population (600 mg ziftomenib)

70% CRc rate (16/23) with 75% (9/12) central measurable residual disease (MRD) negativity (<0.01% threshold), demonstrating deep molecular responses
87% objective response rate (ORR) (20/23)
Median duration of CRc response of 9.2 months (95% CI, 5.8-NE)
Median overall survival (OS) not reached after median follow-up of 10.7 months (N=25)
Venetoclax-Experienced Population (600 mg ziftomenib)

24% CRc rate (6/25) with 50% (3/6) central MRD negativity (<0.01% threshold)
48% ORR (12/25)
Median duration of CRc response of 8.6 months (95% CI, 1.6-NE)
Median OS of 7.4 months after median follow-up of 9.9 months (N=26)
Safety in Both Populations at All Dose Levels (N=67)

The triplet combination was well tolerated, with a safety profile consistent with that reported for ven/aza alone
Low rates of differentiation syndrome (3%, 2/67) observed with the protocol-specified staggered dosing schedule of ven/aza before menin inhibition; both events resolved with protocol-specified mitigation
One case of ziftomenib-related QTc; the event resolved without dose interruption or dose change
Median time to neutrophil and platelet recovery were similar to ven-based regimens alone, supporting feasibility in combination regimens
"For people living with relapsed or refractory NPM1-mutated AML, the need for new treatment regimens remains significant," said Yoshifumi Torii, Ph.D., Chief Medical Officer of Kyowa Kirin. "These published findings in the journal Blood add to our understanding of ziftomenib in combination with venetoclax and azacitidine and reinforce our shared commitment with Kura Oncology to advancing this program with urgency and rigor for patients who may benefit."

The ongoing KOMET-007 Phase 1a/1b trial (NCT05735184) is evaluating ziftomenib in combination with ven/aza in multiple cohorts of newly diagnosed chemotherapy-ineligible AML and relapsed/refractory AML. The trial is also evaluating ziftomenib in combination with cytarabine plus daunorubicin (7+3) in patients with newly diagnosed NPM1-m or KMT2A-rearranged (KMT2A-r) AML, as well as ziftomenib combined with quizartinib plus 7+3 intensive chemotherapy in patients with newly diagnosed AML harboring FLT3-ITD/NPM1-m co-mutations.

Kura and Kyowa Kirin are continuing to evaluate ziftomenib across multiple combination regimens and treatment settings, including in the ongoing pivotal KOMET-017 Phase 3 trials in newly diagnosed NPM1-m and KMT2A-r AML.

(Press release, Kura Oncology, JUN 2, 2026, View Source [SID1234666369])

On June 2, 2026 Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia," "Kazia Therapeutics" or the "Company"), a clinical-stage oncology company advancing therapies designed to reprogram cancer biology and overcome treatment resistance, reported the appointment of James Levine as Chief Financial Officer, effective June 1, 2026. Mr. Levine brings more than two decades of experience across investment banking, executive and financial leadership at publicly traded biotech companies.

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"James has built an impressive career leading financial strategy, strategic transactions and major pharmaceutical collaborations, following an extensive career in investment banking," said Dr. John Friend, CEO, Kazia Therapeutics. "As we advance paxalisib and progress our pipeline, James’ expertise will be central to helping us capitalize on that momentum and continue building long-term value for patients and shareholders."

Most recently, Mr. Levine served as Chief Financial Officer of Cardiff Oncology, a clinical-stage oncology company developing a PLK1 inhibitor therapy for solid tumors. Prior to Cardiff Oncology, Mr. Levine served as CFO of Cidara Therapeutics, an antifungal and antiviral biotech company, where he led the financial structuring of a $568 million licensing collaboration with Mundipharma and a $780 million global partnership with Janssen Pharmaceuticals (Johnson & Johnson). He also served as CEO of Verenium Corporation, an industrial biotech company, where he executed major asset sales for total proceeds of approximately $200 million, as well as Sapphire Energy, a human nutrition-focused biotech.

Earlier in his career, Mr. Levine spent 12 years at Goldman Sachs & Co. as a Managing Director advising pharmaceutical and biotech clients across the U.S. and Europe on financings, mergers and acquisitions and strategic transactions, including landmark deals such as the Glaxo Wellcome and SmithKline Beecham merger. Mr. Levine holds a Master of Business Administration degree from The Wharton School at the University of Pennsylvania.

"I am very excited to be joining Kazia as the Company advances paxalisib across multiple indications and builds out a promising pipeline targeting novel mechanisms of treatment resistance," added Mr. Levine. "I look forward to working closely with the management team to help translate Kazia’s scientific progress into strategic and financial outcomes as we approach what we expect to be a period of meaningful clinical and strategic milestones for the Company."

(Press release, Kazia Therapeutics, JUN 2, 2026, View Source [SID1234666368])

On June 2, 2026 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported it will present the results of its Phase 3 SENTRY trial in a late-breaking oral presentation titled: Selinexor plus ruxolitinib in JAK inhibitor-naïve myelofibrosis: Phase 3 SENTRY trial (LBA6500) at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting today. The presentation will open the Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant session at 9:45 a.m. CT. The SENTRY results were also published this morning in the peer-reviewed Journal of Clinical Oncology (JCO).

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"The Phase 3 SENTRY results represent a meaningful advance for patients with myelofibrosis and underscore the promise of combining selinexor with ruxolitinib," said Dr. John Mascarenhas, Professor of Medicine at the Icahn School of Medicine at Mount Sinai and Director of the Center of Excellence for Blood Cancers and Myeloid Disorders. "What is particularly compelling is the rapid, deep and sustained spleen volume reduction observed in the trial, as spleen response remains one of the most clinically relevant treatment goals in myelofibrosis. The OS Kaplan-Meier curves presented at ASCO (Free ASCO Whitepaper) demonstrate an early and sustained separation between treatment arms, reinforcing the potential of selinexor plus ruxolitinib to meaningfully improve outcomes for patients."

Key Highlights:

Spleen Volume Reduction: The combination of selinexor plus ruxolitinib demonstrated a statistically significant improvement in the co-primary endpoint of spleen volume reduction of 35% or more (SVR35), with rapid, deep and sustained spleen volume reduction seen in the combination arm and a consistent benefit observed across prespecified subgroups. At week 24, SVR35 was achieved in 49.8% of patients randomized to the selinexor combination versus 28.0% of patients randomized to ruxolitinib alone (odds ratio 2.58; 95% CI [1.60 to 4.17]; p<0.0001). Responses occurred early and were sustained, with SVR35 rates of 49.4% in the selinexor combination arm versus 20.3% for ruxolitinib alone at week 12 and 46.9% versus 23.0% at week 36, respectively. SVR35 was achieved at any time in 67.7% of patients randomized to the selinexor combination versus 44.9% randomized to ruxolitinib alone. The mean percent change in spleen volume at week 24 was a reduction of 40.0% for the selinexor combination versus a reduction of 26.7% for ruxolitinib alone. In the selinexor combination, the median selinexor dose was 51.7 mg/week and the median ruxolitinib dose was 23.0 mg/day. Notably, at week 24, superior spleen volume reduction was achieved by the selinexor combination, regardless of the ruxolitinib dose, including by patients receiving less than 15 mg of ruxolitinib per day.
Absolute Total Symptom Score (Abs-TSS): Similar symptom improvement from baseline was observed with the selinexor combination compared to ruxolitinib alone as measured by Abs-TSS at week 24. A mean (95% CI) reduction of 9.9 points (−11.2 to −8.6) was observed in patients randomized to the selinexor combination versus a reduction of 10.9 points (−12.6 to −9.1) in patients randomized to ruxolitinib alone. Symptom reductions were consistent across each of the six domains measured. The adjusted mean difference of 0.97 points (95% CI [-1.07 to 3.02]; p=0.825) in Abs-TSS, a co-primary endpoint, did not meet statistical significance.
Overall Survival: A promising overall survival signal, a pre-specified secondary endpoint, was observed with the selinexor combination compared to ruxolitinib alone. As of February 20, 2026, 224 (95.3%) patients randomized to the selinexor combination and 106 (89.8%) randomized to ruxolitinib alone were alive. With a median follow-up of 11.6 and 12.6 months, respectively, overall survival favored the selinexor combination with a hazard ratio of 0.43 (95% CI [0.19 to 1.00]; nominal one-sided p=0.022) with separation of Kaplan–Meier curves occurring around month 9.
Variant Allele Frequency (VAF) Reduction: Potential disease modification from a pre-specified exploratory endpoint was observed as early as week 24 from baseline in the combination arm. VAF reduction ≥20% at week 24 occurred in 32.0% of patients receiving the selinexor combination versus 23.9% of patients receiving ruxolitinib alone and correlated with SVR35 response.
Circulating Peripheral Blast Counts: Circulating peripheral blasts are a poor prognostic factor and potential marker of disease burden. A post-hoc analysis showed that more patients who received the selinexor combination and who had no detectable circulating peripheral blasts at baseline maintained no detectable blasts through the course of treatment compared to patients who received ruxolitinib alone. For patients with circulating peripheral blasts at baseline, more patients who received the selinexor combination had no detectable blasts through the course of treatment compared to patients who received ruxolitinib alone.
Safety and Tolerability: The combination demonstrated a manageable safety and tolerability profile consistent with the known profile of selinexor and ruxolitinib individually. No new safety signals were observed. Treatment emergent adverse events (TEAEs) occurred in 99.1% of patients receiving the selinexor combination and in 97.4% of patients receiving ruxolitinib alone. The five most common all-grade TEAEs in the selinexor combination arm were thrombocytopenia (selinexor plus ruxolitinib arm: 59%; placebo plus ruxolitinib arm: 43%), anemia (57%; 58%), nausea (57%; 17%), constipation (32%; 36%) and neutropenia (27%; 9%) (n=234; n=116). The rate of grade 3+ TEAEs was 70% in the selinexor combination arm compared to 50% in the placebo plus ruxolitinib arm, and were primarily hematologic in nature. The percentage of patients treated with the combination who experienced TEAEs leading to death occurred in 0.9% of patients receiving the combination compared to 2.6% of patients receiving ruxolitinib alone. Confirmed leukemic transformation was 1.7% in each arm.
"We believe the results presented at ASCO (Free ASCO Whitepaper) today highlight selinexor’s differentiated mechanism of action and its potential to offer a complementary approach to JAK inhibition," said Reshma Rangwala, MD, PhD, Chief Medical Officer and Head of Research of Karyopharm. "Importantly, these findings reinforce the opportunity to target biological pathways beyond JAK signaling to further advance outcomes for patients with myelofibrosis."

The abstract "Selinexor plus ruxolitinib in JAK inhibitor–naïve myelofibrosis: Phase 3 SENTRY trial" (abstract number LBA6500) is available on ASCO (Free ASCO Whitepaper)’s website. A copy of the SENTRY presentation being delivered at ASCO (Free ASCO Whitepaper) will be available under Publications and Presentations in the Investors & Media section of the Company’s website at approximately 11:00 a.m. ET today. Finally, 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 [SID1234666367])

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])