On May 22, 2025 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported seven upcoming poster presentations at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress (Press release, Rigel, MAY 22, 2025, View Source [SID1234653317]). The ASCO (Free ASCO Whitepaper) Annual Meeting is being held in Chicago, Illinois and virtually from May 30 to June 3, 2025. The EHA (Free EHA Whitepaper)2025 Congress is being held in Milan, Italy and virtually from June 12 to June 15, 2025.

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Rigel’s poster presentations will include data for GAVRETO (pralsetinib) for the treatment of metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), including final data from the Phase 1/2 ARROW study, and REZLIDHIA (olutasidenib) for the treatment of relapsed or refractory (R/R) mutated isocitrate dehydrogenase-1 (mIDH1) acute myeloid leukemia (AML).

"We look forward to several posters highlighting the strength of our hematology and oncology product portfolio at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper), including the final efficacy and safety data from the Phase 1/2 ARROW study of GAVRETO. The study data continue to demonstrate GAVRETO’s clinically meaningful and durable responses in patients with RET fusion-positive NSCLC, regardless of prior therapies, with a manageable safety profile. The study also showed promising anti-tumor activity in patients with various RET fusion-positive solid tumors, suggesting the potential for GAVRETO to address these unmet needs," said Raul Rodriguez, Rigel’s president and CEO. "In addition, the collective data being presented on REZLIDHIA support its duration of response and potential clinical benefit when used in earlier lines of treatment for R/R AML patients and in primary refractory patients who are traditionally difficult to treat."

ASCO Annual Meeting abstracts may be accessed online via View Source Details of the poster presentations are as follows:

ASCO Poster Presentations

Saturday, May 31, 2025, 1:30pm to 4:30pm CT
Abstract #: 8644
Title: Efficacy and Safety of Pralsetinib in Patients with Advanced RET-fusion-positive NSCLC: Final Data from the Phase 1/2 ARROW Study
Presenter: Gilberto de Lima Lopes, M.D., MBA

Final top-line efficacy and safety in RET fusion-positive NSCLC patients produced clinically meaningful and durable responses regardless of prior therapies, with a manageable safety profile. These results support the findings in previously published results, with a longer follow up period.
Overall response rate (ORR) was 70.3% and median duration of response (DOR) was 19.1 months in the measurable disease population (n=259). In the efficacy population (n=281), median overall survival (OS) was 44.3 months with median follow up of 47.6 months. Median progression-free survival (PFS) was 13.1 months overall but was longer in the United States (25.9 months) vs. Asia (12.6 months) or Europe (12.9 months).
Sunday, June 1, 2025, 9:00am to 12:00pm CT
Abstract #: 6545
Title: A Phase 2 Study of Olutasidenib in Relapsed/Refractory AML: Outcomes by Number of Prior Treatment Regimens
Presenter: Eunice S. Wang, M.D.

A post-hoc analysis of the pivotal cohort from the Phase 1/2 study evaluated outcomes in patients with R/R mIDH1 AML who received olutasidenib after either 1-2 or ≥3 prior lines of therapy.
Patients in the 1-2 prior regimens group showed higher ORR and complete response (CR) / complete response with hematologic improvement (CRh) rates and longer median OS than those with ≥3 prior lines of therapy, providing a rationale for initiating olutasidenib earlier in the R/R treatment paradigm.
Abstract #: 6546
Title: Matching-adjusted Indirect Comparison (MAIC) of Olutasidenib and Ivosidenib in IDH1-mutated Relapsed/Refractory AML
Presenter: Justin M. Watts, M.D.

In the absence of a head-to-head trial, a matching-adjusted indirect comparison (MAIC) analysis compared relative treatment effects of olutasidenib vs. ivosidenib in mIDH1 R/R AML, leveraging registrational data for olutasidenib and ivosidenib to match patients using key baseline clinical variables.
Naïve and adjusted rates of response for olutasidenib vs. ivosidenib were comparable (adjusted point estimate favored olutasidenib for CR and ivosidenib for CR+CRh), while a longer duration of CR+CRh was observed with olutasidenib. Adjusted OS was similar between the two groups, although the hazard ratio (HR) favored olutasidenib.
Results rely on the assumption of no unmeasured confounders, which reflects a limitation of the methodology.
Monday, June 2, 2025, 1:30pm to 4:30pm CT
Abstract #: 3116
Title: Efficacy and Safety of Pralsetinib in RET Fusion-positive Solid Tumors: Final Data from the ARROW Trial
Presenter: Vivek Subbiah, M.D.

Final results from the Phase 2 portion of ARROW in patients with RET fusion-positive solid tumors other than NSCLC and thyroid cancer showed an ORR of 46.4% (13/28), including an ORR for pancreatic cancer of 100% (5/5).
Overall, 10.7% (3/28) achieved complete response (pancreatic cancer, n=2; cancer of unknown primary, n=1) and 35.7% (10/28) achieved partial response. Median PFS was 7 months and median DOR was 11.1 months. Median OS was 10.3 months.
Pralsetinib demonstrated robust and durable anti-tumor activity, with responses observed in many tumor types. These data validate RET fusions as a tissue-agnostic target with sensitivity to RET inhibition and activity beyond NSCLC and thyroid cancer, further supporting the promising potential of pralsetinib to address the unmet medical need in these patients.
EHA2025 Congress abstracts may be accessed online via the EHA (Free EHA Whitepaper) Library. Details of the poster presentations and publications are as follows:

EHA Poster Presentations

Friday, June 13, 2025, Time 18:30 to 19:30 CEST
Abstract #: PF511
Title: Efficacy and Safety of Olutasidenib Monotherapy in Primary Refractory AML: A Post Hoc Analysis of a Phase 2 Study
Presenter: Antonio Curti, M.D., Ph.D.

In the pivotal cohort of R/R AML patients, 46 were primary refractory to first line treatment or subsequent induction therapy. With olutasidenib therapy, the ORR was 50% (23/46) and 30% (14/46) achieved a CR/CRh, with a mediation duration of CR/CRh of 17.6 months.
The most commonly occurring treatment-emergent adverse events (AEs) were nausea (41%), vomiting (30%), and an increase in white blood cells (30%), with no new safety signals observed.
Olutasidenib as a single agent demonstrated clinically meaningful activity and a durable response in patients with primary refractory AML, with an acceptable tolerability profile, suggesting it may be an effective therapeutic option for this patient population with a traditionally poor prognosis.
Abstract #: PF516
Title: Effect of Mutation Type and Co-mutations on Response to Olutasidenib in Patients With R/R Mutated IDH1 AML
Presenter: Stéphane de Botton, M.D., Ph.D.

In the final five-year analysis of the registrational trial, mutational analysis showed durable responses across IDH1-R132 mutation types, particularly in the absence of RTK pathway co-mutations.
Response rates were lower in patients with ≥4 co-mutations.
Results show that it is possible for patients with deleterious co-mutations (i.e., FLT3, TP53, etc.) to respond favorably to olutasidenib, although the sample sizes are small for some co-mutations.
Abstract #: PF530
Title: Olutasidenib as Maintenance Therapy after Treatment Response in Mutated IDH1 Acute Myeloid Leukemia
Presenter: Andrew H. Wei, MBBS, Ph.D.

In a separate cohort (n=18) of the Phase 2 trial, olutasidenib was evaluated as maintenance therapy in patients who achieved minimal residual disease (MRD)-positive CR or CR with incomplete blood count recovery (CRi) with prior treatment. The 4-month relapse-free survival (RFS) was 83% with a median RFS of 18.4 months. At 12 months, RFS was 71% and OS was 89%. RFS at 2 years was 48%.
Two patients who had received prior venetoclax therapy entered with a CRi, improved to a CRh and ultimately a CR during the study.
Most common treatment-emergent AEs were fatigue (33%), headache (33%) and nausea (28%), with no new safety signals.
Olutasidenib as a single agent demonstrated clinically meaningful activity as a maintenance strategy in a subset of AML patients with CR/CRi and persistent MRD ≥0.01% after prior therapy. The analysis supports the potential benefit of switching to olutasidenib upon response to therapy.
EHA Publications

Abstract #: PB2499
Title: Comparative Effectiveness of Olutasidenib and Ivosidenib in mIDH1 Relapsed or Refractory Acute Myeloid Leukemia Patients Post-Venetoclax: Insights From 2102-HEM-101 and a Real-World External Control
Authors: Catherine Lai, M.D., MPH, Thomas Leahy, Ph.D., CStat, Alex Turner, Ph.D., Amber Thomassen, AGNP-BC, AOCNP, Lixia Wang, Ph.D., Aaron D. Sheppard, Ph.D., Jorge E. Cortes, M.D.

Abstract #: PB2492
Title: A Phase 2 Study of Olutasidenib in Relapsed/Refractory AML: Outcomes by Number of Prior Treatment Regimens
Authors: Eunice S. Wang, M.D., Jorge E. Cortes, M.D., Andrew H. Wei, M.D., Stéphane de Botton, M.D., Ph.D., Antonio Curti, M.D., Ph.D., Pau Montesinos, M.D., Ph.D., Karen W.L. Yee, M.D., Joseph G. Jurcic, M.D., William B. Donnellan, M.D., Jay Yang, M.D., Brian A. Jonas, M.D., Ph.D., Aaron D. Sheppard, Ph.D., Hua Tian, M.D., Justin M. Watts, M.D.

Abstract #: PB2528
Title: Matching-adjusted Indirect Comparison (MAIC) of Olutasidenib (OLU) and Ivosidenib (IVO) in isocitrate dehydrogenase-1 (IDH1)-mutated Relapsed/Refractory (R/R) AML
Authors: Brian A. Jonas, M.D., Ph.D., Justin M. Watts, M.D., Eunice S. Wang, M.D., Florence R. Wilson, MSc, Julie Park, MMath, Shannon Cope, MSc, Aaron D. Sheppard, Ph.D., Jorge E. Cortes, M.D., Stéphane de Botton, M.D., Ph.D.

About NSCLC
It is estimated that over 226,000 adults in the U.S. will be diagnosed with lung cancer in 2025. Lung cancer is the leading cause of cancer death in the U.S, with non-small cell lung cancer (NSCLC) being the most common type accounting for 85-90% of all lung cancer diagnoses.1 RET fusions are implicated in approximately 1-2% of patients with NSCLC.2

About AML
Acute myeloid leukemia (AML) is a rapidly progressing cancer of the blood and bone marrow that affects myeloid cells, which normally develop into various types of mature blood cells. AML occurs primarily in adults and accounts for about 1 percent of all adult cancers. The American Cancer Society estimates that there will be about 22,010 new cases in the United States, most in adults, in 2025.3

Relapsed AML affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow.4,5 Refractory AML, which affects between 10 and 40 percent of newly diagnosed patients, occurs when a patient fails to achieve remission even after intensive treatment.6 Quality of life declines for patients with each successive line of treatment for AML, and well-tolerated treatments in relapsed or refractory disease remain an unmet need.

About GAVRETO (pralsetinib)

INDICATIONS

GAVRETO (pralsetinib) is indicated for the treatment of:

Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test
Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)*
*This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, and fatal ILD/pneumonitis can occur in patients treated with GAVRETO. Pneumonitis occurred in 12% of patients who received GAVRETO, including 3.3% with Grade 3-4, and 0.2% with fatal reactions. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Withhold GAVRETO and promptly investigate for ILD in any patient who presents with acute or worsening of respiratory symptoms (e.g., dyspnea, cough, and fever). Withhold, reduce dose or permanently discontinue GAVRETO based on severity of confirmed ILD.
Hypertension: Occurred in 35% of patients, including Grade 3 hypertension in 18% of patients. Overall, 8% had their dose interrupted and 4.8% had their dose reduced for hypertension. Treatment-emergent hypertension was most commonly managed with anti-hypertension medications. Do not initiate GAVRETO in patients with uncontrolled hypertension. Optimize blood pressure prior to initiating GAVRETO. Monitor blood pressure after 1 week, at least monthly thereafter and as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. Withhold, reduce dose, or permanently discontinue GAVRETO based on the severity.
Hepatotoxicity: Serious hepatic adverse reactions occurred in 1.5% of patients treated with GAVRETO. Increased aspartate aminotransferase (AST) occurred in 49% of patients, including Grade 3 or 4 in 7% and increased alanine aminotransferase (ALT) occurred in 37% of patients, including Grade 3 or 4 in 4.8%. The median time to first onset for increased AST was 15 days (range: 5 days to 2.5 years) and increased ALT was 24 days (range: 7 days to 3.7 years). Monitor AST and ALT prior to initiating GAVRETO, every 2 weeks during the first 3 months, then monthly thereafter and as clinically indicated. Withhold, reduce dose or permanently discontinue GAVRETO based on severity.
Hemorrhagic Events: Serious, including fatal, hemorrhagic events can occur with GAVRETO. Grade ≥3 events occurred in 4.1% of patients treated with GAVRETO including one patient with a fatal hemorrhagic event. Permanently discontinue GAVRETO in patients with severe or life-threatening hemorrhage.
Tumor Lysis Syndrome (TLS): Cases of TLS have been reported in patients with medullary thyroid carcinoma receiving GAVRETO. Patients may be at risk of TLS if they have rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration. Closely monitor patients at risk, consider appropriate prophylaxis including hydration, and treat as clinically indicated.
Risk of Impaired Wound Healing: Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway. Therefore, GAVRETO has the potential to adversely affect wound healing. Withhold GAVRETO for at least 5 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of GAVRETO after resolution of wound healing complications has not been established.
Embryo-Fetal Toxicity: Based on findings from animal studies and its mechanism of action, GAVRETO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with GAVRETO and for 2 weeks after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with GAVRETO and for 1 week after the last dose.
Common adverse reactions (≥25%) were musculoskeletal pain, constipation, hypertension, diarrhea, fatigue, edema, pyrexia, and cough. Common Grade 3/4 laboratory abnormalities (≥2%) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased phosphate, decreased leukocytes, decreased sodium, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), decreased calcium (corrected), decreased platelets, increased alkaline phosphatase, increased potassium, decreased potassium, and increased bilirubin.
Avoid coadministration of GAVRETO with strong or moderate CYP3A inhibitors, P-gp inhibitors, or combined P-gp and strong or moderate CYP3A inhibitors. If coadministration cannot be avoided, reduce the GAVRETO dose. Avoid coadministration of GAVRETO with strong or moderate CYP3A inducers. If coadministration cannot be avoided, increase the GAVRETO dose.
Lactation: Advise women not to breastfeed during treatment with GAVRETO and for 1 week after the last dose.
Pediatric Use: Monitor open growth plates in adolescent patients. Consider interrupting or discontinuing GAVRETO if abnormalities occur.
Click here for Important Safety Information and Full Prescribing Information.

To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

About REZLIDHIA

INDICATION
REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME

Differentiation syndrome, which can be fatal, can occur with REZLIDHIA treatment. Symptoms may include dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension, fever, and weight gain. If differentiation syndrome is suspected, withhold REZLIDHIA and initiate treatment with corticosteroids and hemodynamic monitoring until symptom resolution.

WARNINGS AND PRECAUTIONS

Differentiation Syndrome
REZLIDHIA can cause differentiation syndrome. In the clinical trial of REZLIDHIA in patients with relapsed or refractory AML, differentiation syndrome occurred in 16% of patients, with grade 3 or 4 differentiation syndrome occurring in 8% of patients treated, and fatalities in 1% of patients. Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal. Symptoms of differentiation syndrome in patients treated with REZLIDHIA included leukocytosis, dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, fever, edema, pyrexia, and weight gain. Of the 25 patients who experienced differentiation syndrome, 19 (76%) recovered after treatment or after dose interruption of REZLIDHIA. Differentiation syndrome occurred as early as 1 day and up to 18 months after REZLIDHIA initiation and has been observed with or without concomitant leukocytosis.

If differentiation syndrome is suspected, temporarily withhold REZLIDHIA and initiate systemic corticosteroids (e.g., dexamethasone 10 mg IV every 12 hours) for a minimum of 3 days and until resolution of signs and symptoms. If concomitant leukocytosis is observed, initiate treatment with hydroxyurea, as clinically indicated. Taper corticosteroids and hydroxyurea after resolution of symptoms. Differentiation syndrome may recur with premature discontinuation of corticosteroids and/or hydroxyurea treatment. Institute supportive measures and hemodynamic monitoring until improvement; withhold dose of REZLIDHIA and consider dose reduction based on recurrence.

Hepatotoxicity
REZLIDHIA can cause hepatotoxicity, presenting as increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased blood alkaline phosphatase, and/or elevated bilirubin. Of 153 patients with relapsed or refractory AML who received REZLIDHIA, hepatotoxicity occurred in 23% of patients; 13% experienced grade 3 or 4 hepatotoxicity. One patient treated with REZLIDHIA in combination with azacitidine in the clinical trial, a combination for which REZLIDHIA is not indicated, died from complications of drug-induced liver injury. The median time to onset of hepatotoxicity in patients with relapsed or refractory AML treated with REZLIDHIA was 1.2 months (range: 1 day to 17.5 months) after REZLIDHIA initiation, and the median time to resolution was 12 days (range: 1 day to 17 months). The most common hepatotoxicities were elevations of ALT, AST, blood alkaline phosphatase, and blood bilirubin.

Monitor patients frequently for clinical symptoms of hepatic dysfunction such as fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. Obtain baseline liver function tests prior to initiation of REZLIDHIA, at least once weekly for the first two months, once every other week for the third month, once in the fourth month, and once every other month for the duration of therapy. If hepatic dysfunction occurs, withhold, reduce, or permanently discontinue REZLIDHIA based on recurrence/severity.

ADVERSE REACTIONS
The most common (≥20%) adverse reactions, including laboratory abnormalities, were aspartate aminotransferase increased, alanine aminotransferase increased, potassium decreased, sodium decreased, alkaline phosphatase increased, nausea, creatinine increased, fatigue/malaise, arthralgia, constipation, lymphocytes increased, bilirubin increased, leukocytosis, uric acid increased, dyspnea, pyrexia, rash, lipase increased, mucositis, diarrhea and transaminitis.

DRUG INTERACTIONS

Avoid concomitant use of REZLIDHIA with strong or moderate CYP3A inducers.
Avoid concomitant use of REZLIDHIA with sensitive CYP3A substrates unless otherwise instructed in the substrates prescribing information. If concomitant use is unavoidable, monitor patients for loss of therapeutic effect of these drugs.
LACTATION
Advise women not to breastfeed during treatment with REZLIDHIA and for 2 weeks after the last dose.

GERIATRIC USE
No overall differences in effectiveness were observed between patients 65 years and older and younger patients. Compared to patients younger than 65 years of age, an increase in incidence of hepatotoxicity and hypertension was observed in patients ≥65 years of age.

HEPATIC IMPAIRMENT
In patients with mild or moderate hepatic impairment, closely monitor for increased probability of differentiation syndrome.

Click here for Important Safety Information and Full Prescribing Information, including Boxed WARNING.

To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

GAVRETO and REZLIDHIA are registered trademarks of Rigel Pharmaceuticals, Inc.

On May 22, 2025 Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported financial results for the fiscal fourth quarter and year ended March 31, 2025 and provided a business update (Press release, Replimune, MAY 22, 2025, View Source [SID1234653316]).

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"As we near our PDUFA date, our commercial organization is now fully hired and ready to execute our first launch in advanced melanoma," said Sushil Patel, Ph.D., CEO of Replimune. "We have a deep understanding of the market landscape, prescriber adoption and referral patterns, and a launch plan optimized for intra-tumoral delivery across all customer segments. We believe the opportunity for RP1 to help improve the lives of patients with advanced melanoma is significant. We estimate approximately 13,000 patients progress on or after PD-1 treatment annually in the U.S. with approximately 80% of these patients eligible for treatment with RP1. Importantly, these treatments will take place in the outpatient setting and not require hospitalization. We look forward to further discussing our commercial plans for RP1 and pipeline development for RP1 and RP2 at an investor day on June 24th."

Program Highlights & Milestones

RP1 (vusolimogene oderparepvec)

RP1 combined with Opdivo (nivolumab) in anti-PD1 failed melanoma
The FDA recently completed their late-cycle review and manufacturing inspections for the biologics license application, which remains on schedule ahead of a July 22, 2025 PDUFA date.
The FDA has indicated no advisory committee is planned.
The Company completed the build out of its commercial infrastructure, including the hiring and training of customer-facing teams. Distribution channels have been established and are ready to receive product, pending approval, and key state licensing is in place.
Enrollment is ongoing in the confirmatory Phase 3 trial, IGNYTE-3, with over 100 sites planned globally. This trial is expected to enroll 400 patients and is assessing RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment. The primary endpoint of this trial is overall survival and key secondary endpoints are progression free survival and overall response rate.
RP2

RP2 in uveal melanoma
The registration-directed REVEAL trial of RP2 in metastatic uveal melanoma is currently enrolling. The clinical trial is expected to enroll approximately 280 patients with metastatic uveal melanoma who are immune checkpoint inhibitor-naïve and evaluate RP2 in combination with nivolumab versus ipilimumab in combination with nivolumab. The primary endpoints of the trial are overall survival and progression free survival, and key secondary endpoints are overall response rate and disease control rate.
RP2 in hepatocellular carcinoma (HCC)
The Phase 2 clinical trial of RP2 combined with atezolizumab and bevacizumab in anti-PD1/PD-L1 progressed HCC is currently enrolling. The clinical trial will evaluate RP2 combined with the second-line therapy of atezolizumab and bevacizumab and is expected to enroll 30 patients. The trial is being conducted under a collaboration and supply agreement with Roche.
Upcoming Events

American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting being held May 30-June 3, 2025:
Poster: Response analysis for injected and non-injected lesions and the safety and efficacy of superficial and deep/visceral RP1 injection in the registrational cohort of anti-PD-1 failed melanoma patients of the IGNYTE trial
Poster: Biosafety analysis from the skin cancer cohorts in the IGNYTE clinical trial of RP1
Poster: A randomized, controlled, multicenter, phase 3 study of vusolimogene oderparepvec combined with nivolumab vs. treatment of physician’s choice in patients with advanced melanoma that has progressed on anti-PD-1 and anti-CTLA-4 therapy (IGNYTE-3)
Poster: A randomized, phase 2/3 clinical trial investigating RP2 plus nivolumab vs. ipilimumab plus nivolumab in immune checkpoint inhibitor-naïve patients with metastatic uveal melanoma
Additional poster from an investigator sponsored trial: A phase 1/2 study of vusolimogene oderparepvec (RP1) in primary melanoma (mel) to reduce the risk of sentinel lymph node (SLN) metastasis.
Fireside chat at the Jefferies Global Healthcare Conference on Thursday, June 5, 2025 at 4:20 PM ET
Replimune to host an Investor Day on Tuesday, June 24, 2025 at 10:00 AM ET
Financial Highlights

Cash Position: As of March 31, 2025, cash, cash equivalents and short-term investments were $483.8 million, as compared to $420.7 million as of fiscal year ended March 31, 2024. The increase in cash balance was a result of the public offering in November 2024, somewhat offset by cash utilized in operating activities in advancing the Company’s clinical development plans.

Based on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments, as of March 31, 2025 will enable the Company to fund operations into the fourth quarter of 2026 which includes scale up for the potential commercialization of RP1 in skin cancers and for working capital and general corporate purposes and excludes any potential revenue.
R&D Expenses: Research and development expenses were $54.0 million for the fiscal fourth quarter and $189.4 million for the fiscal year ended March 31, 2025, as compared to $42.6 million for the fiscal fourth quarter and $175.0 million for the fiscal year ended March 31, 2024. This increase was primarily due to an increase in personnel-related costs as we scaled operations in preparation for commercial launch of RP1, as well as consulting and facility-related costs. Research and development expenses included $4.5 million in stock-based compensation expenses for the fiscal fourth quarter and $18.4 million for the fiscal year ended March 31, 2025.
S,G&A Expenses: Selling, general and administrative expenses were $25.4 million for the fiscal fourth quarter and $72.2 million for the fiscal year ended March 31, 2025, as compared to $16.2 million for the fiscal fourth quarter and $59.8 million for the fiscal year ended March 31, 2024. Selling, general and administrative expenses included $3.8 million in stock-based compensation expenses for the fiscal fourth quarter and $16.6 million for the fiscal year ended March 31, 2025.
Net Loss: Net loss was $74.1 million for the fiscal fourth quarter and $247.3 million for the fiscal year ended March 31, 2025, as compared to a net loss of $55.1 million for the fiscal fourth quarter and $215.8 million for the fiscal ended March 31, 2024.

Conference Call

In connection with this announcement, Replimune will host a conference call and webcast at 8:00 AM ET today. Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should use this link. A replay of the webcast will be available via the Company’s investor website approximately two hours after the call’s conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time.

About RP1

RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About RP2

RP2 is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity.

On May 22, 2025 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported initial results from two cohorts of the Phase 1b LINKER-MM2 trial evaluating linvoseltamab in combination with two different proteasome inhibitors (PI) – carfilzomib or bortezomib – in patients with relapsed/refractory (R/R) multiple myeloma (MM) (Press release, Regeneron, MAY 22, 2025, View Source [SID1234653315]). The trial included patients who had progressed after at least two lines of therapy and were either double-class refractory (immunomodulatory drug [IMiD] and PI) or triple-class exposed (IMiD, PI and anti-CD38 monoclonal antibody). The data will be featured in two oral presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting on Monday, June 2 at 8:00 AM CDT.

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"In clinical trials, treatment with linvoseltamab monotherapy in later-line settings generated impressive response rates, warranting investigation in earlier lines as well as in combination with other cancer therapies," said Salomon Manier, M.D., Ph.D., Professor of Hematology at Lille University Hospital in France. "While early, these compelling results for linvoseltamab combination therapy demonstrated high rates of clinical activity, even amongst those with previous exposure to the proteasome inhibitors evaluated in the cohorts. We look forward to seeing these results mature to see if these benefits can be maintained."

Linvoseltamab combined with carfilzomib showed strong responses in R/R MM
All treated patients (n=23) had previous exposure to PIs and more than half (n=12) were refractory to at least one PI. Moreover, 48% had baseline soft tissue plasmacytomas, and 39% were over 75 years old, representing a patient population with high-risk features. Of the 21 patients evaluable for efficacy, 11 patients received linvoseltamab 100 mg, and five patients each received linvoseltamab 150 mg or 200 mg prior to initiation of carfilzomib.

With a median follow-up of 15 months, efficacy results across all dose levels showed a 90% objective response rate (ORR; 19 of 21 patients), with 76% (16 of 21 patients) achieving a complete response (CR). At 12 months, the estimated probability of maintaining a response was 87% (n=19; 95% confidence interval [CI]: 56% to 97%) and being progression-free was 83% (n=21; 95% CI: 55% to 94%). A registrational, randomized Phase 3 trial investigating this combination against standard-of-care in the same setting is planned.

Among the 23 patients evaluable for safety, the most common treatment emergent adverse events (TEAEs; >50%) of any grade and Grade ≥3 were neutropenia (65% and 56.5%), cytokine release syndrome (CRS; 61% and 0%), diarrhea (52% and 4%) and thrombocytopenia (52% and 30%). Infections occurred in 91% of patients (Grade ≥3: 43.5%, including one fatality). Serious adverse events (SAEs) occurred in 83% of patients. One dose-limiting toxicity (DLT) of Grade 4 thrombocytopenia during tumor lysis syndrome was observed in the 100 mg dose level, and one Grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS) was observed in the 150 mg dose level.

Additional linvoseltamab combination with bortezomib showed promising clinical activity in R/R MM
Among enrolled patients (n=24), 6 received linvoseltamab at 100 mg and 18 at 200 mg before initiating bortezomib. More than half were refractory to PIs, including 58% to carfilzomib and 13% to bortezomib. Of the 20 patients evaluable for efficacy and with a median duration of follow-up of 9 months, results across dose levels showed an 85% ORR (17 of 20 patients), with 50% (10 of 20 patients) achieving a CR.

The most common TEAEs (>50%) of any grade and Grade ≥3 were CRS (58% and 0%), neutropenia (54% and 50%) and thrombocytopenia (54% and 37.5%). Four patients experienced ICANS (one Grade 1 and three Grade 2). Infections occurred in 75% of patients (Grade ≥3: 38%). SAEs occurred in 83% of patients. Two patients died due to adverse events: one due to pneumonia deemed related to treatment and occurring prior to initiation of bortezomib, and another due to COVID-19 deemed unrelated to treatment. One DLT of Grade 3 cytomegalovirus reactivation was observed in the 200 mg dose level.

The uses of linvoseltamab in combination with either carfilzomib or bortezomib in patients with R/R MM are investigational and have not been approved by any regulatory authority.

Linvoseltamab is approved in the European Union as Lynozyfic for adults to treat R/R MM that has progressed after at least three prior therapies (including a PI, an IMiD and an anti-CD38 monoclonal antibody) and that has demonstrated progression on the last therapy. For complete product information, please see the Summary of Product Characteristics that can be found on www.ema.europa.eu. In the U.S., the FDA accepted for review the Biologics License Application for linvoseltamab in adults with R/R MM with a target action date of July 10, 2025.

About Multiple Myeloma
As the second most common blood cancer, there are over 187,000 new cases of MM diagnosed globally every year, with more than 36,000 diagnosed and 12,000 deaths anticipated in the U.S. in 2025. In the U.S., there are approximately 8,000 people who have MM that has progressed after three lines of therapy. The disease is characterized by the proliferation of cancerous plasma cells (MM cells) that crowd out healthy blood cells in the bone marrow, infiltrate other tissues and cause potentially life-threatening organ injury. Despite treatment advances, MM is not curable and while current treatments are able to slow progression of the cancer, most patients will ultimately experience cancer progression and require additional therapies.

About LINKER-MM2
LINKER-MM2 is a Phase 1b, open-label clinical trial evaluating linvoseltamab in combination with other cancer treatments in patients with R/R MM. Combination treatments include standard-of-care and novel therapies such as IMiD, PIs, anti-CD38 antibodies, checkpoint inhibitors, and a gamma secretase inhibitor. The primary endpoints are incidence of DLTs (dose-finding portion only) and incidence and severity of TEAEs. Secondary endpoints include ORR, DoR and progression-free survival.

In the carfilzomib cohort, linvoseltamab is administered first with an initial step-up dosing regimen followed by at least two full doses (100, 150 or 200 mg) before initiation of carfilzomib (56 mg/m²). In the bortezomib cohort, the same initial step-up process is followed but linvoseltamab is administered with at least one full dose (100 or 200 mg) before initiation of bortezomib (1.3 mg/m²).

About the Linvoseltamab Clinical Development Program
Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.

Linvoseltamab is being investigated in a broad clinical development program exploring its use as a monotherapy as well as in combination regimens across different lines of therapy in MM, including earlier lines of treatment, as well as plasma cell precursor disorders.

In addition to LINKER-MM2, trials include:

LINKER-MM1: Phase 1/2 dose-escalation and dose-expansion trial evaluating the safety, tolerability, dose-limiting toxicities and anti-tumor activity of linvoseltamab monotherapy in R/R MM
LINKER-MM3: Phase 3 confirmatory trial evaluating linvoseltamab monotherapy compared to the combination of elotuzumab, pomalidomide and dexamethasone in R/R MM
Phase 1 trial evaluating linvoseltamab in combination with a Regeneron CD38xCD28 costimulatory bispecific in R/R MM
LINKER-MM4: Phase 1/2 trial evaluating linvoseltamab monotherapy in newly diagnosed MM
LINKER-SMM1: Phase 2 trial evaluating linvoseltamab monotherapy in high-risk smoldering MM
LINKER-MGUS1: Phase 2 dose-ranging trial evaluating linvoseltamab monotherapy in high-risk monoclonal gammopathy of unknown significance and non-high-risk SMM
LINKER-AL2: Phase 1/2 trial evaluating linvoseltamab monotherapy in R/R systemic light chain amyloidosis
For more information on Regeneron’s clinical trials in blood cancer, visit the clinical trials website, or contact via [email protected] or 844-734-6643.

About Regeneron in Hematology
At Regeneron, we’re applying more than three decades of biology expertise with our proprietary VelociSuite technologies to develop medicines for patients with diverse blood cancers and rare blood disorders.

Our blood cancer research is focused on bispecific antibodies that are being investigated both as monotherapies and in various combinations and emerging therapeutic modalities. Together, they provide us with unique combinatorial flexibility to develop customized and potentially synergistic cancer treatments.

Our research and collaborations to develop potential treatments for rare blood disorders include explorations in antibody medicine, gene editing and gene-knockout technologies, and investigational RNA-approaches focused on depleting abnormal proteins or blocking disease-causing cellular signaling.

On May 22, 2025 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported initial results from two cohorts of the Phase 1b LINKER-MM2 trial evaluating linvoseltamab in combination with two different proteasome inhibitors (PI) – carfilzomib or bortezomib – in patients with relapsed/refractory (R/R) multiple myeloma (MM) (Press release, Regeneron, MAY 22, 2025, View Source [SID1234653315]). The trial included patients who had progressed after at least two lines of therapy and were either double-class refractory (immunomodulatory drug [IMiD] and PI) or triple-class exposed (IMiD, PI and anti-CD38 monoclonal antibody). The data will be featured in two oral presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting on Monday, June 2 at 8:00 AM CDT.

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"In clinical trials, treatment with linvoseltamab monotherapy in later-line settings generated impressive response rates, warranting investigation in earlier lines as well as in combination with other cancer therapies," said Salomon Manier, M.D., Ph.D., Professor of Hematology at Lille University Hospital in France. "While early, these compelling results for linvoseltamab combination therapy demonstrated high rates of clinical activity, even amongst those with previous exposure to the proteasome inhibitors evaluated in the cohorts. We look forward to seeing these results mature to see if these benefits can be maintained."

Linvoseltamab combined with carfilzomib showed strong responses in R/R MM
All treated patients (n=23) had previous exposure to PIs and more than half (n=12) were refractory to at least one PI. Moreover, 48% had baseline soft tissue plasmacytomas, and 39% were over 75 years old, representing a patient population with high-risk features. Of the 21 patients evaluable for efficacy, 11 patients received linvoseltamab 100 mg, and five patients each received linvoseltamab 150 mg or 200 mg prior to initiation of carfilzomib.

With a median follow-up of 15 months, efficacy results across all dose levels showed a 90% objective response rate (ORR; 19 of 21 patients), with 76% (16 of 21 patients) achieving a complete response (CR). At 12 months, the estimated probability of maintaining a response was 87% (n=19; 95% confidence interval [CI]: 56% to 97%) and being progression-free was 83% (n=21; 95% CI: 55% to 94%). A registrational, randomized Phase 3 trial investigating this combination against standard-of-care in the same setting is planned.

Among the 23 patients evaluable for safety, the most common treatment emergent adverse events (TEAEs; >50%) of any grade and Grade ≥3 were neutropenia (65% and 56.5%), cytokine release syndrome (CRS; 61% and 0%), diarrhea (52% and 4%) and thrombocytopenia (52% and 30%). Infections occurred in 91% of patients (Grade ≥3: 43.5%, including one fatality). Serious adverse events (SAEs) occurred in 83% of patients. One dose-limiting toxicity (DLT) of Grade 4 thrombocytopenia during tumor lysis syndrome was observed in the 100 mg dose level, and one Grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS) was observed in the 150 mg dose level.

Additional linvoseltamab combination with bortezomib showed promising clinical activity in R/R MM
Among enrolled patients (n=24), 6 received linvoseltamab at 100 mg and 18 at 200 mg before initiating bortezomib. More than half were refractory to PIs, including 58% to carfilzomib and 13% to bortezomib. Of the 20 patients evaluable for efficacy and with a median duration of follow-up of 9 months, results across dose levels showed an 85% ORR (17 of 20 patients), with 50% (10 of 20 patients) achieving a CR.

The most common TEAEs (>50%) of any grade and Grade ≥3 were CRS (58% and 0%), neutropenia (54% and 50%) and thrombocytopenia (54% and 37.5%). Four patients experienced ICANS (one Grade 1 and three Grade 2). Infections occurred in 75% of patients (Grade ≥3: 38%). SAEs occurred in 83% of patients. Two patients died due to adverse events: one due to pneumonia deemed related to treatment and occurring prior to initiation of bortezomib, and another due to COVID-19 deemed unrelated to treatment. One DLT of Grade 3 cytomegalovirus reactivation was observed in the 200 mg dose level.

The uses of linvoseltamab in combination with either carfilzomib or bortezomib in patients with R/R MM are investigational and have not been approved by any regulatory authority.

Linvoseltamab is approved in the European Union as Lynozyfic for adults to treat R/R MM that has progressed after at least three prior therapies (including a PI, an IMiD and an anti-CD38 monoclonal antibody) and that has demonstrated progression on the last therapy. For complete product information, please see the Summary of Product Characteristics that can be found on www.ema.europa.eu. In the U.S., the FDA accepted for review the Biologics License Application for linvoseltamab in adults with R/R MM with a target action date of July 10, 2025.

About Multiple Myeloma
As the second most common blood cancer, there are over 187,000 new cases of MM diagnosed globally every year, with more than 36,000 diagnosed and 12,000 deaths anticipated in the U.S. in 2025. In the U.S., there are approximately 8,000 people who have MM that has progressed after three lines of therapy. The disease is characterized by the proliferation of cancerous plasma cells (MM cells) that crowd out healthy blood cells in the bone marrow, infiltrate other tissues and cause potentially life-threatening organ injury. Despite treatment advances, MM is not curable and while current treatments are able to slow progression of the cancer, most patients will ultimately experience cancer progression and require additional therapies.

About LINKER-MM2
LINKER-MM2 is a Phase 1b, open-label clinical trial evaluating linvoseltamab in combination with other cancer treatments in patients with R/R MM. Combination treatments include standard-of-care and novel therapies such as IMiD, PIs, anti-CD38 antibodies, checkpoint inhibitors, and a gamma secretase inhibitor. The primary endpoints are incidence of DLTs (dose-finding portion only) and incidence and severity of TEAEs. Secondary endpoints include ORR, DoR and progression-free survival.

In the carfilzomib cohort, linvoseltamab is administered first with an initial step-up dosing regimen followed by at least two full doses (100, 150 or 200 mg) before initiation of carfilzomib (56 mg/m²). In the bortezomib cohort, the same initial step-up process is followed but linvoseltamab is administered with at least one full dose (100 or 200 mg) before initiation of bortezomib (1.3 mg/m²).

About the Linvoseltamab Clinical Development Program
Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.

Linvoseltamab is being investigated in a broad clinical development program exploring its use as a monotherapy as well as in combination regimens across different lines of therapy in MM, including earlier lines of treatment, as well as plasma cell precursor disorders.

In addition to LINKER-MM2, trials include:

LINKER-MM1: Phase 1/2 dose-escalation and dose-expansion trial evaluating the safety, tolerability, dose-limiting toxicities and anti-tumor activity of linvoseltamab monotherapy in R/R MM
LINKER-MM3: Phase 3 confirmatory trial evaluating linvoseltamab monotherapy compared to the combination of elotuzumab, pomalidomide and dexamethasone in R/R MM
Phase 1 trial evaluating linvoseltamab in combination with a Regeneron CD38xCD28 costimulatory bispecific in R/R MM
LINKER-MM4: Phase 1/2 trial evaluating linvoseltamab monotherapy in newly diagnosed MM
LINKER-SMM1: Phase 2 trial evaluating linvoseltamab monotherapy in high-risk smoldering MM
LINKER-MGUS1: Phase 2 dose-ranging trial evaluating linvoseltamab monotherapy in high-risk monoclonal gammopathy of unknown significance and non-high-risk SMM
LINKER-AL2: Phase 1/2 trial evaluating linvoseltamab monotherapy in R/R systemic light chain amyloidosis
For more information on Regeneron’s clinical trials in blood cancer, visit the clinical trials website, or contact via [email protected] or 844-734-6643.

About Regeneron in Hematology
At Regeneron, we’re applying more than three decades of biology expertise with our proprietary VelociSuite technologies to develop medicines for patients with diverse blood cancers and rare blood disorders.

Our blood cancer research is focused on bispecific antibodies that are being investigated both as monotherapies and in various combinations and emerging therapeutic modalities. Together, they provide us with unique combinatorial flexibility to develop customized and potentially synergistic cancer treatments.

Our research and collaborations to develop potential treatments for rare blood disorders include explorations in antibody medicine, gene editing and gene-knockout technologies, and investigational RNA-approaches focused on depleting abnormal proteins or blocking disease-causing cellular signaling.

On May 22, 2025 QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported a new commercial partnership and co-marketing agreement with ID Solutions, a French provider of high-quality digital PCR (dPCR) assays and customized molecular testing solutions for oncology and other disease areas, to expand the availability of dPCR assays for oncology research applications (Press release, Qiagen, MAY 22, 2025, View Source [SID1234653314]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The combination of QIAGEN’s global reach and automation expertise with the assay development and manufacturing capabilities of ID Solutions will strengthen QIAGEN’s position in oncology research.

Under the agreement, ID Solutions will manufacture and supply dPCR assays for non-clinical research use on QIAGEN’s QIAcuity platforms. These assays are optimized to simultaneously detect multiple mutations in cell-free DNA (cfDNA) from plasma and genomic DNA (gDNA) from formalin-fixed, paraffin-embedded (FFPE) tissue. QIAGEN will commercialize these kits starting in Europe as the first region, with the potential for future expansion into other regions.

This agreement supports QIAGEN’s strategic focus on accelerating the adoption of the QIAcuity dPCR platform in oncology research. The new assays expand QIAGEN’s portfolio, complementing the existing PanCancer Kits for detecting multiple hallmark mutations in DNA from diverse sample types and over 200 LNA (locked nucleic acid) Mutation Assays available via its GeneGlobe platform. This unique platform integrates pre-designed assays with a database of more than 10,000 biological entities, including genes, miRNAs, pathogens and pathways.

"Through our collaboration with ID Solutions, we are reinforcing our commitment at QIAGEN to providing comprehensive dPCR solutions on QIAcuity that address critical needs in oncology research," said Simona Grandits, Vice President, Head of Commercial Operations for the Europe, Middle East and Africa (EMEA) Region at QIAGEN. "This agreement expands our assay portfolio, strengthens our position in oncology research, and supports faster, more reproducible results on the QIAcuity platform for our customers."

The partnership aligns with ID Solutions mission to develop its assays for research use only on fully integrated platforms. "Partnering with QIAGEN enables us to extend the reach of our high-quality dPCR assays to more laboratories," said Lise Grewis, CEO, ID Solutions. "Together, we’re enabling faster adoption of dPCR in oncology research with robust, reliable results."

For customers, this partnership translates into streamlined access to ready-to-use assays optimized for QIAcuity in non-clinical oncology research, expanding beyond the current menu, enabling results in less than a day and meeting the growing demand for deeper molecular insights.

To learn more about QIAGEN’s dPCR solutions and the new assays available through this partnership, visit View Source