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])

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])

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 Stelexis BioSciences, Inc. (Stelexis) reported results from a Phase 1 clinical trial (NCT06533761) of eganelisib, an oral, first-in-class PI3K-gamma inhibitor, in 21 patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) or higher-risk myelodysplastic syndrome (HR-MDS). The data were presented in an oral session at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting by Mendel Goldfinger, M.D., of Montefiore Einstein Comprehensive Cancer Center.

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Key Findings

The trial recruited a heavily pretreated patient population that was uniformly characterized by features that convey an unfavorable prognosis:
29% TP53-deleted or -mutated
90% abnormal cytogenetics
76% received more than two prior therapies
76% received prior venetoclax
A modified objective response rate (defined as CR + Stable Disease with neutrophil count improvement) was achieved in:
50% (6/12) of patients with high PI3K-gamma expression vs.
0% (0/8) of patients with low PI3K-gamma expression (p<0.05, Fisher’s exact test), using immunohistochemical staining of bone marrow biopsies
Responses included molecular and major cytogenetic remissions in two patients in CR
Five of six responding patients had severe or life-threatening neutropenia at baseline, and all five patients demonstrated rapid neutrophil count improvements, including a rapid normalization of neutrophil counts in four patients, consistent with induction of myeloid differentiation
Median overall survival (OS) was 27 weeks in PI3K-gamma-high patients vs. 9.9 weeks in low expressors (HR 0.22; 95% CI 0.07–0.75)
Based on historical patient data from the publicly available TCGA database, PI3K-gamma-high expression is an adverse prognostic factor for OS in patients receiving conventional therapy, thereby supporting a substantial clinical benefit observed following treatment with eganelisib in this study.

Eganelisib was well tolerated at both dose levels (45 mg and 60 mg, once daily) with no dose-limiting toxicities and no intrinsic hematologic toxicity. This is consistent with the myeloid-restricted expression of PI3K-gamma, and with the observation that PI3K-gamma is dispensable for normal hematopoiesis (Gu et al., Blood 2024).

The majority of adverse events in this study were disease-related rather than treatment-related, consistent with the underlying patient population. Treatment-related AEs were predominantly low-grade with no Grade 5 related AEs. Of note, no eganelisib-related SAEs were observed and no patient discontinued treatment due to an eganelisib-related AE.

Published outcomes for patients with relapsed/refractory disease who failed frontline venetoclax and hypomethylating agent therapy have shown a median overall survival of approximately 2.4 months (Maiti et al., Haematologica 2021), underscoring the high unmet need in this population.

"The preliminary data generated by eganelisib in patients with heavily pretreated AML and higher-risk MDS is encouraging," said Konstantinos N. Aprilakis, M.D., Board Member at Stelexis and Partner at Deerfield Management. "In addition to a favorable safety and tolerability profile, Stelexis has observed evidence of biologic and clinical activity for eganelisib in a particularly difficult-to-treat patient population. I am especially delighted that Stelexis has identified a biomarker that may be used to identify patients most likely to benefit from treatment with eganelisib. These clinical data suggest that eganelisib has the potential to be effective across multiple hematologic malignancies of high unmet need."

"For nearly 20 years now, the field has been searching for therapies that offer a better prognosis to MDS-patients than hypomethylating agents alone. For far too long, clinicians had to primarily rely on classifying and selecting patients for investigational treatment based on prognostic scores or bone marrow blast counts, alone. It is time we begin to classify patients based on disease-specific, functional, biological vulnerabilities and offer therapies that selectively target those biological vulnerabilities" said Manuel Aivado, MD, PhD, President and Chief Executive Officer of Stelexis BioSciences. "We believe that myeloid malignancies may find in PI3K-gamma an analog to HER2 in breast cancer, and we are thrilled that the ground-breaking discoveries of our co-founders have paved Stelexis’ way to this doorstep."

Based on these results, Stelexis plans to advance eganelisib into a randomized expansion cohort with hypomethylating agents in treatment-naïve, PI3K-gamma-high MDS patients with an IPSS-R category of intermediate, high, or very-high risk or with CMML-2.

About Eganelisib
Eganelisib is a first-in-class, oral, highly potent, and isoform-selective inhibitor of PI3K-gamma, the myeloid-restricted isoform of the PI3K kinase family. PI3K-gamma is dispensable in normal hematopoiesis and lymphocytes, differentiating it from delta-class PI3K inhibitors that have been associated with significant immune-mediated adverse events.

In myeloid malignancies, PI3K-gamma signaling reinforces the differentiation block characteristic of AML and higher-risk MDS through PAK1, identifying PI3K-gamma as a therapeutic target whose inhibition can re-engage myeloid differentiation without imposing intrinsic myelosuppression or lymphoid toxicity.

(Press release, Stelexis Therapeutics, JUN 2, 2026, View Source [SID1234666383])

On June 2, 2026 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a clinical-stage company developing transformative therapies for the treatment of cancer and other diseases, reported updated efficacy and safety data from the investigator-initiated Phase 2 303 Study evaluating pembrolizumab plus Plinabulin and docetaxel in patients with metastatic non-small cell lung cancer ("NSCLC") after progression on first-line immune checkpoint inhibitor ("ICI") therapy, either alone or in combination with chemotherapy. The data were presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting by Dr. Mengzhao Wang and Dr. Yan Xu, principal investigators from Peking Union Hospital.

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First-in-class small molecule agent Plinabulin is a brain-penetrant, uniquely reversible tubulin binder with immunomodulatory properties that promote dendritic cell maturation, M1 polarization and anti-tumor T-cell responses. As a GEF-H1 agonist, Plinabulin is designed to strengthen the cancer-immunity cycle, support immune activation, and help address chemotherapy-induced neutropenia, providing a potential differentiated approach in the post-ICI treatment setting.

The open-label Phase 2 study enrolled 47 patients with metastatic NSCLC who had progressed following prior ICI therapy, including 6 patients previously treated with ICI alone and 41 patients previously treated with ICI plus platinum-doublet chemotherapy. All patients had secondary resistance, defined as prior ICI treatment with progression-free survival of at least six months. Pembrolizumab (200 mg), Plinabulin (30 mg/m2) and docetaxel (75 mg/m2) were all dosed intravenously on day 1 of a 21-day cycle.

As of the February 28, 2026 data cutoff, the median follow-up was 28.8 months. Three patients remained on treatment, and 24 patients remained alive in survival follow-up. Among the 47 enrolled patients, the median age was 67 years; 80.9% were male and 19.1% were female; 72.3% were current or former smokers; and histology included 63.8% non-squamous and 36.2% squamous NSCLC. The key results at the database lock are summarized below.

Median Progression-Free Survival (PFS): 7.0 months — compared favorably with historical docetaxel data in similar post-ICI patient populations, including TROPION-Lung01 and EVOKE-01, which reported median PFS of 3.7 months and 3.9 months, respectively
Median Duration of Response (DoR): 9.3 months – indicating durable response
Disease Control Rate (DCR: PR + SD > 4 months): 79.5% — indicating clinical benefit in the majority of patients who progressed on prior PD-1/L1 inhibitor-based therapy
Confirmed Objective Response Rate (ORR): 18.2% — compared favorably with historical 5-12% ORR for docetaxel, demonstrating anti-tumor activity in metastatic NSCLC patients with secondary resistance to prior ICI
12-Month Overall Survival (OS) Rate: 78.1%; 24-Month OS Rate: 58.0%, with median OS not reached — compared favorably with historical docetaxel data in similar patient populations, including TROPION-Lung01 and EVOKE-01, which reported median OS of 11.8 months and 9.8 months, respectively
The combination demonstrated a generally manageable safety profile. 53.2% of patients experienced grade 3 or higher treatment-related adverse events, including hypertension in 17.0%, gastrointestinal disorders in 14.9%, neutrophil decrease in 17.0%, decreased white blood cell count in 6.4%, and febrile neutropenia in 2.1%
"These updates continue to support Plinabulin’s potential to address one of the most significant unmet needs in lung cancer: treatment options for patients whose disease has progressed after ICI therapy," said Dr. Mengzhao Wang, principal investigator from Peking Union Hospital in China. "With 24-month OS rate of 58%, together with 80% of disease control and encouraging immune activation and hematologic benefit, we believe Plinabulin may offer a differentiated approach to re-sensitizing tumors to immunotherapy with durable long-term benefit while improving the therapeutic profile of docetaxel-based regimens."

BeyondSpring’s ASCO (Free ASCO Whitepaper) 2026 Presentation

Title: A Phase 2 Study of Plinabulin (Plin)/Docetaxel (Doc) plus Pembrolizumab (Pemb) in Metastatic NSCLC (mNSCLC) After Acquired Resistance (AR) to Anti-PD-1/L1 Alone or in Chemotherapy Combination: Efficacy and Immunophenotyping
Presenter/Authors: Yan Xu, Minjiang Chen, Xiaoxing Gao, Huiyu Huang, Yue Chang, Xiaoyan Liu, Wei Zhong, Jing Zhao, RuiLi Pan, Taisheng Li, Mengzhao Wang
Session: Lung Cancer – Non-Small Cell Metastatic (Track)
Abstract Number: 8567

(Press release, BeyondSpring Pharmaceuticals, JUN 2, 2026, View Source [SID1234666399])