Karyopharm’s Phase 3 SENTRY Trial of Selinexor Plus Ruxolitinib in Myelofibrosis Selected for Late-Breaking Oral Presentation at EHA 2026

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])

Evogene Announces Successful Completion of Phase 1 Clinical Study of BMC128, a Rationally Designed Live Bacterial Product, in Combination with Nivolumab by its Subsidiary Biomica

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])

Disc Medicine Presents Updated Positive Data from RALLY-MF Phase 2 Trial in Patients with Myelofibrosis (MF) and Anemia at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting

On June 2, 2026 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported updated data from the RALLY-MF Phase 2 trial of DISC-0974 in anemia of MF at the ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago, IL. In this updated data set, treatment with DISC-0974 shows substantial reductions in hepcidin and increases in iron levels translating to positive impact on clinically meaningful measures of anemia across a broad range of patient types.

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"We are excited to have solidified and strengthened the magnitude, durability, and consistency of responses as we have enrolled more patients and extended follow-up," said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc Medicine. "The activity observed both with and without background JAK inhibitor therapy, together with improvements in transfusion burden and fatigue, continues to support the potential for DISC-0974 to serve a broad population of patients living with MF-associated anemia, an area where substantial unmet need remains."

This ongoing Phase 2 open-label study had enrolled 61 adult patients with MF and anemia as of the data cutoff date of April 27, including 50 patients with sufficient follow up to be included in the responder analysis (non-transfusion dependent receiving no transfusions (nTD, n=31), transfusion dependent with low transfusion burden (TD Low, n=11) and transfusion dependent with high transfusion burden (TD High, n=8)). The trial was comprised of both patients receiving concomitant JAK inhibitor therapy (n=25) and not receiving JAK inhibitor therapy (n=25). DISC-0974 was administered subcutaneously at 50 mg every 4 weeks for up to 6 treatments. The updated results demonstrated:

Consistent, substantial decreases in hepcidin reaching >75% reduction from baseline and corresponding increases in serum iron
55% (N=17 of 31) of baseline nTD patients achieved a hemoglobin increase of ≥1.5 g/dL for ≥12 weeks (major response) and 68% had an increase of ≥1 g/dL for ≥12 weeks (overall response)
64% (N=7 of 11) of TD Low patients achieved transfusion independence (TI, major response) over a 16-week period and 73% achieved a ≥50% reduction in transfusions (overall response)
50% (N=4 of 8) of TD High patients achieved transfusion independence (TI, major response) over a 12-week period and 88% achieved a ≥50% reduction in transfusion requirement (overall response)
56% of patients receiving concomitant JAK inhibitor therapy achieved a major hematologic response across transfusion groups and 72% achieved an overall response, with similar response rates regardless of which specific JAK inhibitor the patient received
Dosing with DISC-0974 was associated with improvements in patient-reported outcomes:
Clinically significant improvements in FACIT-Fatigue scores in nTD and TD Low participants that were correlated with hemoglobin change
MPN-SAF TSS50 at EOS was achieved by 50% of nTD and TD low major responders
DISC-0974 was generally well-tolerated. Diarrhea, not considered serious, was the only adverse event (AE) that was reported as related to DISC-0974 and reported in two or more subjects. The majority of AEs were not considered related to DISC-0974.

Additional data from the RALLY-MF study is to be shared in Q4 2026, with an end of Phase 2 meeting with the FDA expected to occur by end of year.

DISC-0974 is an investigational agent and is not approved for use as a therapy in any jurisdiction worldwide

(Press release, Disc Medicine, JUN 2, 2026, View Source [SID1234666398])

Cellectar Biosciences to Highlight Compelling New Efficacy Data from Phase 2b CLOVER WaM Study of Iopofosine I 131 in r/r Waldenström Macroglobulinemia at the American Society of Clinical Oncology Annual Meeting

On June 1, 2026 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported that efficacy results from a subset of patients treated with iopofosine I 131 immediately post-Bruton Tyrosine Kinase inhibitor (BTKi) therapy in the Company’s Phase 2 CLOVER WaM clinical trial of iopofosine I 131 to treat relapsed or refractory (r/r) Waldenström macroglobulinemia (WM) will be highlighted today in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper) taking place May 29-June 2, 2026 in Chicago, Illinois.

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"We are highly encouraged by these results from the CLOVER WaM study, which demonstrate compelling efficacy and durable responses with iopofosine I 131 in the particularly challenging patient population that has progressed following BTKi therapy. I look forward to highlighting these positive outcomes at this year’s ASCO (Free ASCO Whitepaper)," said Jarrod Longcor, chief operating officer of Cellectar Biosciences. "Patients with immediate post-BTKi disease represent a distinct clinical population within WM that is characterized by limited responses and rapid disease progression after BTKi discontinuation. In addition, there is no FDA-approved treatment that reliably provides durable disease control in this setting. These outcomes give us even greater confidence in the potential of iopofosine to be effective in an earlier line setting as will be evaluated in the planned Phase 3 confirmatory study."

In the CLOVER WaM Phase 2 clinical trial, eligible WM patients received greater than two prior therapies and had symptomatic disease requiring therapy. Treatment consisted of two cycles of iopofosine I 131 administered at 15 mCi/m2 on days 1 and 15 of each 57-day cycle. The primary efficacy endpoint was major response rate (MRR). This subset analysis assessed a modified intent-to-treat (mITT) population (all patients who received ≥60 mCi total administered dose of iopofosine I 131), and whose immediately prior treatment was a BTKi. Data cut off for this analysis was January 16, 2026.

Highlights of the Data:

Iopofosine I 131 demonstrated significant efficacy (n=24):
100% clinical benefit rate
87.5% overall response rate
79.2% major response rate, partial response or better
Median duration of response (DOR) of 16 months (range: 7.3 – 25.4 months)
20% of patients exceeded 30 months DOR
The treatment was well-tolerated with a manageable toxicity profile with cytopenias as the only Grade 3 or greater adverse event.
"These new data further reinforce the compelling clinical profile of iopofosine I 131, demonstrating meaningful efficacy in a subset of WM patients following BTKi treatment," said James Caruso, president and chief executive officer. "The strength and consistency of response observed in this post-BTKi population underscore iopofosine’s potential to address a critical unmet need in the second line setting and beyond. Based on these findings, we plan to pursue accelerated approval in the U.S. and initiate a confirmatory Phase 3 study in the fourth quarter of 2026. We remain committed to bringing iopofosine to the thousands of patients who may benefit from this therapy."

Details of the poster presentation are as follows:

Title: "Iopofosine I-131 after BTK inhibitors in Waldenström macroglobulinemia: CLOVER-WaM subgroup efficacy and safety"
Poster: 592
Date/Time: June 1, 2026, 9:00am – 12:00pm CDT
Presenter: Jarrod Longcor

(Press release, Cellectar Biosciences, JUN 1, 2026, https://www.cellectar.com/investors/news-events/press-releases/detail/393/cellectar-biosciences-to-highlight-compelling-new-efficacy-data-from-phase-2b-clover-wam-study-of-iopofosine-i-131-in-rr-waldenstrm-macroglobulinemia-at-the-american-society-of-clinical-oncology-annual-meeting [SID1234666301])

The European Commission approves PharmaMar’s Zepzelca® (lurbinectedin) for the treatment of extensive-stage small cell lung cancer in combination with atezolizumab

On June 1, 2026 PharmaMar (MSE: PHM), reported that the European Commission (EC) has approved the combination of Zepzelca (lurbinectedin) with atezolizumab (Tecentriq) as a first-line maintenance treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC), whose disease has not progressed following standard induction therapy. This approval follows the positive opinion issued on March 27th by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) concerning this treatment.

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Luis Mora, Managing Director of PharmaMar, points out that "it is great news that European patients and doctors now have access to a new treatment for this type of cancer. We believe it has the potential to change the paradigm of treatment for this disease, so we are looking forward to it being available soon in hospitals across Europe."

The approval is based on data from the Phase 3 IMforte trial, sponsored by Roche in collaboration with Jazz Pharmaceuticals, in which the combination of lurbinectedin and atezolizumab as maintenance treatment in first-line ES-SCLC was associated with a 46% reduction in the risk of disease progression or death and a 27% reduction in the risk of death compared with atezolizumab monotherapy.

In addition, lurbinectedin has been approved as an orphan drug, a designation granted by the EMA to medicines intended for the treatment of rare or uncommon diseases affecting fewer than 5 people per 10,000 inhabitants in the European Union.

Each year, around 62,000 new cases of SCLC are diagnosed in Europe, with most patients presenting advanced disease at the time of diagnosis .

Lurbinectedin in combination with atezolizumab has already been approved in 13 other countries, including the United States, for first-line maintenance treatment of this disease.

(Press release, PharmaMar, JUN 1, 2026, View Source [SID1234666317])