On May 21, 2026 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported the final data from the Phase 3 AcceleRET-Lung clinical trial of GAVRETO (pralsetinib) as first-line treatment of rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) will be presented in an oral session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Friday, May 29, 2026.

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In addition, the ASCO (Free ASCO Whitepaper) Annual Meeting and European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress will feature poster presentations that include additional data for pralsetinib and data for REZLIDHIA (olutasidenib) for the treatment of relapsed or refractory (R/R) isocitrate dehydrogenase-1 (mIDH1)-mutated acute myeloid leukemia (AML). The ASCO (Free ASCO Whitepaper) Annual Meeting is being held in Chicago, Illinois and virtually from May 29 to June 2, 2026 and the EHA (Free EHA Whitepaper)2026 Congress is being held in Stockholm, Sweden and virtually from June 11 to June 14, 2026.

"Having an oral presentation at ASCO (Free ASCO Whitepaper) as well as multiple additional data presentations at both upcoming medical conferences underscores the continued clinical relevance of our oncology portfolio. We’re pleased that data from the AcceleRET-Lung clinical study will be presented for the first time and the real-world outcome data for olutasidenib will be presented for patients with relapsed/refractory mIDH1 AML previously treated with venetoclax, further validating its role as a treatment option for these patients," said Raul Rodriguez, Rigel’s president and CEO. "Together, these data reinforce our ability to deliver targeted therapies that significantly improve the lives of patients with difficult-to-treat cancers. We look forward to sharing these data with the medical community."

Key highlights from the presentations at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) include:

In the Phase 3 AcceleRET clinical trial, pralsetinib met the primary progression-free survival (PFS) endpoint and had a significantly greater overall response rate and more durable response vs. standard of care, demonstrating the clinical utility of pralsetinib in RET fusion-positive NSCLC. In terms of safety, there were 32 (30.0%) and 26 (25.0%) deaths in the pralsetinib and standard of care groups, respectively, with 8 (7.4%) and 0 due to infection. Increased monitoring suggests severe infection risk can be effectively managed.
In the Phase 1/2 ARROW clinical study of pralsetinib in patients with RET altered thyroid cancer and medullary thyroid cancer, pralsetinib yielded clinically meaningful and durable responses with a manageable safety profile, consistent with prior reports.
In an analysis of the patient, disease and molecular characteristics of long-term (LT) complete remission (CR)/CR with partial hematologic recovery (CRh) (>12 months duration of response) in the registrational Phase 2 clinical trial evaluating olutasidenib in patients with R/R mIDH1 AML, olutasidenib enabled LT CR/CRh in half of patients with CR/CRh without transplant (longest response >54 months). Estimated 48-month overall survival was 74% (95% CI: 51%, 88%).
In a separate real-world assessment evaluating treatment patterns, safety and effectiveness of adults with R/R mIDH1 AML receiving olutasidenib following a venetoclax-based therapy in routine practice (73% of patients received olutasidenib as second-line therapy), a subgroup of patients that historically has very poor outcomes, 51 charts were collected from 18 physicians. Olutasidenib demonstrated robust real-world effectiveness with a CR/CRh rate of 60.8% and CR rate of 57% and a median response duration of 30.3 months. Substantial reductions in transfusion dependence further support olutasidenib as a viable post-venetoclax therapeutic option. These findings suggest that earlier sequencing of olutasidenib in the treatment paradigm may optimize patient outcomes.
ASCO Annual Meeting abstracts may be accessed online via View Source EHA (Free EHA Whitepaper)2026 Congress abstracts may be accessed online via the EHA (Free EHA Whitepaper) Library.

ASCO Presentations

Abstract Title

Lead Author / Presenter

Presentation Type / Abstract #

Session Title

Session Date / Time (CT)

GAVRETO (pralsetinib)

Efficacy and safety of pralsetinib as first-line treatment of RET fusion-positive advanced or metastatic non-small cell lung cancer (NSCLC): The phase 3 AcceleRET-Lung study

Sanjay Popat, MBBS, FRCP, PhD

Oral presentation #8504

Lung Cancer—Non-Small Cell Metastatic

Friday, May 29, 2026 1:00pm – 4:00pm

Efficacy and safety of pralsetinib in advanced or metastatic RET-altered thyroid cancer (TC): Final analysis of the phase 1/2 ARROW study

Vivek Subbiah, MD

Poster presentation #6028

Head and Neck Cancer

Saturday, May 30, 2026

1:30pm – 4:30pm

Efficacy and Safety of Pralsetinib in RET Fusion-Positive Solid Tumors: Data From the TAPISTRY Trial

Chia-Chi Lin, MD, PhD

Poster presentation #3144

Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

Saturday, May 30, 2026

1:30pm – 4:30pm

Clinical factors driving use of RET inhibitor pralsetinib and associated real-world outcomes in RET fusion–positive NSCLC: A retrospective chart review

Makenzi Evangelist, MD

Publication #e20731

Lung Cancer—Non-Small Cell Metastatic

REZLIDHIA (olutasidenib)

Acute myeloid leukemia (AML) patient, disease, and molecular characteristics associated with a long-term (LT) response to olutasidenib

Justin M. Watts, MD

Poster presentation #6523

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Monday, June 1, 2026

9:00am – 12:00pm

Real-World Treatment Patterns and Outcomes with Olutasidenib After Venetoclax in IDH1-Mutated AML Using EHR Data

Yasmin Abaza, MD

Publication #e18514

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Treatment Patterns and Outcomes with Olutasidenib After Venetoclax in IDH1-Mutated AML Using Real-World Data from Chart Review

Pinkal Desai, MD, MPH

Publication #e18527

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Evaluating the cost per month of response for olutasidenib (OLU) versus ivosidenib (IVO) for patients with relapsed/refractory (R/R) mutant IDH1 (mIDH1) acute myeloid leukaemia (AML)

Yasmin Abaza, MD

Publication #e18504

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

EHA Presentations

Abstract Title

Lead Author / Presenter

Presentation Type / Abstract #

Session Date / Time (CEST)

REZLIDHIA (olutasidenib)

Treatment Patterns and Outcomes with Olutasidenib After Venetoclax in IDH1-Mutated AML Using Real-World Data from Chart Review

Pinkal Desai, MD, MPH

Poster presentation #PS1502

Saturday, June 13, 2026 (18:45 – 19:45 CEST)

Acute myeloid leukemia (AML) patient, disease, and molecular characteristics associated with a long-term (LT) response to olutasidenib

Stéphane de Botton, MD, PhD

Poster presentation #PS1625

Saturday, June 13, 2026 (18:45 – 19:45 CEST)

Delphi Consensus on Optimal Treatment Strategies Using IDH1 Inhibitors in Patients with R/R mIDH1 AML

Justin M. Watts, MD

Publication #PB2795

Real-World Treatment Patterns and Outcomes with Olutasidenib After Venetoclax in IDH1-Mutated AML Using EHR Data

Yasmin Abaza, MD

Publication #PB2610

TAVALISSE (fostamatinib disodium hexahydrate)

Health-Related Quality of Life (HRQoL) Among Patients With Immune Thrombocytopenia (ITP) Treated With Fostamatinib in the FORTE Study

Amber Afzal, MD, MSCI

Publication #PB4295

About NSCLC
It is estimated that over 229,000 adults in the U.S. will be diagnosed with lung cancer in 2026. 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 77% 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 22,720 new cases in the United States, most in adults, in 2026.3

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 ITP
In patients with immune thrombocytopenia (ITP), the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. Patients suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

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

WARNING: SERIOUS INFECTIONS, INCLUDING OPPPORTUNISTIC INFECTIONS

GAVRETO may increase the risk for serious infections, including bacterial, fungal, viral and opportunistic infections, which can lead to hospitalization or death. Withhold, reduce the dose or permanently discontinue GAVRETO based on severity.

WARNINGS AND PRECAUTIONS

Serious Infections, Including Opportunistic Infections: GAVRETO may increase the risk for serious infections, including fatal and opportunistic infections. In the AcceleRET-Lung trial, infections occurred in 72% of patients who received GAVRETO, including 18% with Grade 3 and 3.7% with Grade 4 and 7% with fatal outcomes. Among the patients who received chemotherapy/immunotherapy, infections occurred in 52%, including 10% with Grade 3. Infections in the GAVRETO arm included pneumonia, urinary tract infection, opportunistic infections (such as pneumocystis jirovecii pneumonia and fungal infections) and others. Monitor patients for signs and symptoms of infection and treat appropriately. Withhold, reduce the dose, or permanently discontinue GAVRETO based on severity.
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.
ADVERSE REACTIONS

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.
DRUG INTERACTIONS

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, including Boxed WARNING.

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.

About TAVALISSE
Indication
TAVALISSE (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Important Safety Information

Warnings and Precautions

Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to ≥3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.
Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.
Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.
TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.
Drug Interactions

Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.
It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.
Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.
Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.
Adverse Reactions

Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).
Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.
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).

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

(Press release, Rigel, MAY 21, 2026, View Source [SID1234665937])

On May 21, 2026 Mabwell (688062.SH, 02493.HK), an innovation-driven biopharmaceutical company with a fully integrated industry chain, reported it will present multiple clinical study results of its novel Nectin-4-targeting ADC 9MW2821 (Bulumtatug Fuvedotin, BFv) at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, including the Phase Ib/II clinical study data of 9MW2821 in combination with toripalimab for locally advanced or metastatic urothelial carcinoma (la/mUC) in the form of oral presentation, and the Phase II clinical study data of 9MW2821 in combination with toripalimab for perioperative muscle-invasive bladder cancer (MIBC) in the form of poster presentation.

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The Phase Ib/II clinical study of 9MW2821 in combination with toripalimab for the treatment of patients with la/mUC enrolled a total of 52 patients with advanced urothelial carcinoma. Follow-up results showed that as of December 1, 2025, 47 subjects were included in the efficacy analysis. The overall objective response rate (ORR) was 83.0%, confirmed ORR was 74.5%, complete response (CR) rate was 12.8%, and disease control rate (DCR) was 89.4%; and for the previously untreated populations, ORR was 87.5%, confirmed ORR was 80.0%, CR rate was 12.5% and DCR was 92.5%. The median progression-free survival (PFS) was 12.9 months, median duration of response (DoR) and median overall survival (OS) was not yet reached. No new safety signals related to 9MW2821 or toripalimab were observed in this study.

The Phase II clinical study on 9MW2821 in combination with toripalimab for patients with perioperative MIBC enrolled a total of 32 subjects. As of January 4, 2026, 7 subjects completed neoadjuvant therapy (9MW2821 in combination with toripalimab). Among these subjects, 6 subjects completed radical cystectomy and regional lymph node dissection, and 1 subject refused radical surgery due to achieving clinical CR following neoadjuvant therapy. Pathological complete response (pCR) was 66.7% (4/6), and pathological downstaging (pDS) rate was 83.3% (5/6). No new safety signals related to 9MW2821 or toripalimab were observed in this study.

About 9MW2821

9MW2821 is a novel Nectin-4-targeting ADC independently developed by Mabwell based on its ADC development platform. Mabwell is currently conducting multiple clinical studies for several indications including urothelial carcinoma, cervical cancer, esophageal cancer and breast cancer. It is the world’s first Nectin-4 ADC to enter Phase III clinical trials for cervical cancer (CC) and triple-negative breast cancer (TNBC). Four pivotal Phase III clinical studies are underway. 9MW2821 has obtained FDA Fast Track Designation for three indications, Orphan Drug Designation for one indication, and Breakthrough Therapy Designation from the CDE of NMPA for two indications.

Interim analysis for the Phase III clinical trials of urothelial carcinoma (UC) monotherapy, UC combination therapy and CC monotherapy are planned to be conducted in 2026, and Applications for pre-NDA meetings are expected to be submitted to the Center for Drug Evaluation under the National Medical Products Administration based on the data of interim analysis. Phase Ib/II clinical trial of CC combination therapy is planned to be completed in the second half of 2026, followed by a Phase III clinical trial to be initiated.

(Press release, Mabwell Biotech, MAY 21, 2026, View Source [SID1234665953])

On May 21, 2026 Gilead Sciences, Inc. (Nasdaq: GILD) reported that together with Kite, a Gilead company, it will present more than 25 abstracts, including six oral presentations, at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting (May 29 – June 2) and the 2026 EHA (Free EHA Whitepaper) Congress (June 11 – 14). These presentations underscore the increasing diversity of Gilead’s oncology portfolio and pipeline reflecting a growing body of evidence across both solid tumors and hematologic malignancies. Collectively, the data demonstrate Gilead and Kite’s leadership in antibody-drug conjugates (ADCs) and CAR T-cell therapy.

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Key presentations support continued momentum ahead of near-term potential launch opportunities, including new data analyses for Trodelvy (sacituzumab govitecan-hziy) in first-line metastatic triple-negative breast cancer (mTNBC) and anitocabtagene autoleucel (anito-cel), an investigational agent for relapsed or refractory multiple myeloma (RRMM). Together with abstracts addressing earlier-stage innovation, manufacturing experience and real-world evidence, these data highlight a portfolio that is increasingly positioned to deliver durable impact at scale.

"We are at a pivotal inflection point in the evolution of our oncology portfolio, with late-stage programs advancing alongside a rapidly maturing pipeline," said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. "The data we are presenting at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) highlight the trajectory we are building across antibody-drug conjugates and cell therapy, while reinforcing the clinical, manufacturing and operational foundation to sustain long-term leadership in oncology and deliver meaningful advances for people living with cancer."

Key presentations at ASCO (Free ASCO Whitepaper) include:

ASCENT-04 and ASCENT-03 Analyses: Gilead will present new analyses during oral sessions from the Phase 3 ASCENT-04 and ASCENT-03 studies that further define the clinical profile of Trodelvy with or without Keytruda (pembrolizumab) in first-line mTNBC, including evaluation of progression-free survival after next-line treatment (PFS2) in each study (Abstract #s LBA1000 and 1001). PFS2 is a measure that provides important context around durable, long-term clinical effect beyond the first progression. The ASCENT-04 PFS2 data for Trodelvy plus Keytruda will be shared as part of ASCO (Free ASCO Whitepaper)’s press program.
Anito-cel Clinical Trial Manufacturing: Kite will present for the first time data on the anito-cel clinical trial manufacturing experience in patients with RRMM with at least one prior therapy or newly diagnosed MM from the Phase 3 iMMagine-3 and the Phase 2 GEM-AnitoFIRST study in collaboration with the GEM/PETHEMA Foundation, respectively. These findings highlight manufacturing consistency and operational execution supporting broader clinical development (Abstract #2550).
CAR T for the Treatment of Recurrent Glioblastoma: Research collaborators at the University of Pennsylvania Perelman School of Medicine will deliver an oral presentation featuring updated Phase 1 data exploring CAR T-cell therapy in recurrent glioblastoma, reflecting continued progress in advancing cell therapy approaches in solid tumors (Abstract #2013).
Key presentations at EHA (Free EHA Whitepaper) include:

KITE-753 Phase 1 Study: Updated Phase 1 results for KITE-753, Kite’s enhanced DuoCore CAR T-cell therapy for relapsed/refractory B-cell lymphoma, showing encouraging safety and durability of efficacy results that support its continued development (Abstract #4208619).
Summary of Presentations

Accepted abstracts at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting can be found at www.ASCO.org and include:

Title

Abstract Details

Breast Cancer

Progression-free survival after next line of treatment (PFS2) and subsequent therapies (subs tx) in the ASCENT-04 study of participants (pts) with previously untreated PD-L1+ metastatic triple-negative breast cancer (mTNBC) treated with sacituzumab govitecan (SG) plus pembrolizumab (pembro) vs chemotherapy (chemo) plus pembro

Abstract #LBA1000

Oral Presentation

June 2, 2026

9:45 – 9:57 AM CDT

Progression-free survival after next line of treatment (PFS2) and subsequent therapies (subs tx) in the ASCENT-03 study of participants (pts) with previously untreated metastatic triple-negative breast cancer (mTNBC) treated with sacituzumab govitecan (SG) vs chemotherapy (chemo)

Abstract #1001

Oral Presentation

June 2, 2026

9:57 – 10:09 AM CDT

ASCENT-04: Analysis of efficacy by biomarker subgroups with sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in participants (pts) with previously untreated PD-L1+ metastatic triple-negative breast cancer (mTNBC)

Abstract #1013

Rapid Oral Presentation

May 31, 2026

11:30 – 11:36 AM CDT

ASCENT-03: Efficacy by biomarker subgroup with sacituzumab govitecan (SG) vs chemotherapy (chemo) in participants (pts) with previously untreated advanced triple-negative breast cancer (TNBC) who are not candidates for PD-(L)1 inhibitors (PD-[L]1i)

Abstract #1014

Rapid Oral Presentation

May 31, 2026

11:36 – 11:42 AM CDT

Using ML to predict rapid progression for patients (pts) with HR+/HER2- metastatic breast cancer (mBC) treated with frontline (1L) CDK 4/6 inhibitors (CDK 4/6i)

Abstract #1025

Poster Presentation

June 1, 2026

1:30 – 4:30 PM CDT

Subgroup analysis of participants (pts) with HER2 IHC0 in the ASCENT-07 study of sacituzumab govitecan (SG) vs chemotherapy in HR+/HER2- metastatic breast cancer (mBC)

Abstract #1065

Poster Presentation

June 1, 2026

1:30 – 4:30 PM CDT

Early deviations from guideline-concordant care in triple-negative breast cancer: A patient-reported analysis

Abstract #e13528

Online Publication Only

May 21, 2026

4:00 PM CDT

Real-world utilization of a patient-centric symptom management guide for metastatic breast cancer

Abstract #e23403

Online Publication Only

May 21, 2026

4:00 PM CDT

Ovarian Cancer

NAPISTAR 1-01: Results of phase 1 dose escalation of monotherapy with TUB-040, a novel NaPi2b-targeting exatecan ADC, in patients (pts) with platinum-resistant ovarian cancer (PROC)

Abstract #5513

Rapid Oral Presentation

May 30, 2026

8:36 – 8:42 AM CDT

Multiple Myeloma

Anitocabtagene autoleucel (anito-cel) clinical trial manufacturing experience in patients with relapsed/refractory (RR) or newly diagnosed (ND) multiple myeloma (MM)**

Abstract #2550

Poster Presentation

May 30, 2026

1:30 – 4:30 PM CDT

Glioblastoma

Updated overall survival, safety, and neurologic function outcomes from a phase 1 trial of bivalent chimeric antigen receptor (CAR) T-cell therapy in recurrent glioblastoma (GBM)***

Abstract #2013

Rapid Oral Presentation

May 31, 2026

5:06 – 5:12 PM CDT

Large B-cell Lymphoma

KITE-753: A phase 2 study of an autologous anti-CD19/CD20 CAR T-cell therapy in CAR-naive patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL)

Abstract #TPS7098

Poster Presentation

June 1, 2026

9:00 AM – 12:00 PM CDT

Long-term real-world outcomes of axicabtagene ciloleucel (axi-cel) in relapsed/refractory (R/R) large B-cell lymphoma (LBCL)

Abstract #7028

Poster Presentation

June 1, 2026

9:00 AM – 12:00 PM CDT

CAR T-cell Therapy Resource Utilization

Real-world healthcare resource utilization (HCRU) following chimeric antigen receptor (CAR) T-cell therapy in U.S. patients treated in new authorized treatment centers (ATCs) without FACT accreditation

Abstract #e19515

Online Publication Only

May 21, 2026

4:00 PM CDT

*In collaboration with Viver Health

**In collaboration with the GEM/PETHEMA Foundation

***Collaborative study with the University of Pennsylvania Perelman School of Medicine

Accepted abstracts at the 2026 EHA (Free EHA Whitepaper) Congress highlight Kite’s expertise in CAR T-cell therapy and include:

Title

Abstract Details

Large B-cell Lymphoma

A Phase 1 Study of KITE-753 in Patients (Pts) With Relapsed/Refractory (R/R) B-Cell Lymphoma: Updated Safety and Efficacy Results

Abstract #4208619

Poster Presentation

June 13, 2026

6:45 – 7:45 PM CEST

Axicabtagene Ciloleucel as Second-Line Treatment in Patients With Late-Relapsed Large B-Cell Lymphoma: Interim Analysis of the LATE-R Clinical Trial From the Spanish Lymphoma Group GELTAMO*

Abstract #4207969

Poster Presentation

June 12, 2026

6:45 – 7:45 PM CEST

Clinical and Economic Outcomes by Risk Group Among First-Line Patients With Large B-Cell Lymphoma in the United States—SEER-Medicare Data Analysis

Abstract #4210325

Publication Only

May 12, 2026

Real-World (RW) Treatment Patterns and Survival Outcomes in Patients (Pts) With Newly Diagnosed High-Risk (HR) Large B-Cell Lymphoma (LBCL)

Abstract #4206903

Poster Presentation

June 12, 2026

6:45 – 7:45 PM CEST

International Expert Consensus on Real-World CAR T-Cell Eligibility in Large B-Cell Lymphomas: An E-Delphi Study

Abstract #4206912

Poster Presentation

June 12, 2026

6:45 – 7:45 PM CEST

Global Variation in CAR T-Cell Therapy Practice Patterns for LBCL: Quantitative Research Findings

Abstract #4210262

Publication Only

May 12, 2026

Axicabtagene Ciloleucel for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma in Brazil: The Impact of CAR T-Cell Therapy Wait Time and Treatment Sequencing

Abstract #4210270

Publication Only

May 12, 2026

Cost-Effectiveness of Axicabtagene Ciloleucel for Treating Taiwanese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma and High-Grade B-Cell Lymphoma After First-Line Treatment

Abstract #4209065

Poster Presentation

June 13, 2026

6:45 – 7:45 PM CEST

Cost-Effectiveness of Axicabtagene Ciloleucel in Taiwanese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma and Primary Mediastinal B-Cell Lymphoma After Two Lines of Systemic Therapy

Abstract #4207302

Poster Presentation

June 12, 2026

6:45 – 7:45 PM CEST

Mantle Cell Lymphoma

Biologic Correlates of Long-Term Response After Brexucabtagene Autoleucel Therapy in Mantle Cell Lymphoma: Product Phenotype, PK, and Baseline Features

Abstract #4208752

Poster Presentation

June 13, 2026

6:45 – 7:45 PM CEST

Acute Lymphoblastic Leukemia

Cost-Effectiveness Analysis of Brexucabtagene Autoleucel in Adults With Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukaemia in Singapore

Abstract #4209064

Poster Presentation

June 13, 2026

6:45 – 7:45 PM CEST

Non-Hodgkin Lymphoma

Follow-Up-Time-Adjusted Non-Relapse Mortality (NRM) in Patients With Non-Hodgkin Lymphoma Following Chimeric Antigen Receptor (CAR) T-Cell Therapy Within Clinical Trials

Abstract #4208663

Poster Presentation

June 13, 2026

6:45 – 7:45 PM CEST

Multiple Myeloma

Anitocabtagene Autoleucel Clinical Trial Manufacturing Experience in Patients With Relapsed/Refractory or Newly Diagnosed Multiple Myeloma**

Abstract #4209802

Publication Only

Cell Therapy Healthcare Resource Utilization

CAR T Cell Therapy in Clinical Routine: Quantification of Real-World Hospital Resource Use Across CAR T Care Pathway in Germany

Abstract #4207303

Poster Presentation

June 12, 2026

6:45 – 7:45 PM CEST

*Collaborative study with the Spanish Lymphoma Group GELTAMO

**In collaboration with the GEM/PETHEMA Foundation

The use of Trodelvy plus Keytruda in patients with first-line PD-L1+ metastatic TNBC and Trodelvy as monotherapy in patients with first-line metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitors are investigational, and the safety and efficacy of these uses have not been established.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About Trodelvy

Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect.

Trodelvy is currently approved in more than 60 countries for second-line or later metastatic triple-negative breast cancer (TNBC) and in more than 50 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer (mBC). Outside of Europe, Gilead has submitted supplemental applications to the U.S. Food and Drug Administration (FDA) for approval of Trodelvy based on the ASCENT-03 and ASCENT-04 studies.

Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression. These studies with Trodelvy, both in monotherapy and in combination with pembrolizumab, involve earlier lines of treatment for TNBC and HR+/HER2- breast cancer—including in curative settings—as well as in lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity.

About Anito-cel

Anitocabtagene autoleucel (anito-cel, previously ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in relapsed or refractory multiple myeloma that utilizes Arcellx’s novel and compact binder known as the D-Domain. The small, D-Domain binder potentially enables high CAR expression without tonic signaling and is designed to quickly release from the BCMA target. This combination may allow for the potential elimination of multiple myeloma cells without severe immunotoxicity. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration.

About KITE-753

KITE-753 is an investigational, bicistronic autologous CAR T-cell therapy engineered to potentially overcome tumor antigen heterogeneity and may prevent relapse. The KITE DuoCore construct uniquely combines anti-CD19 and anti-CD20 targeting with dual co-stimulation (CD28 and 4-1BB). KITE-753 utilizes a novel manufacturing process, aiming to preserve T-cell fitness.

U.S. INDICATIONS FOR TRODELVY

TRODELVY (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:

Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
U.S. IMPORTANT SAFETY INFORMATION FOR TRODELVY

BOXED WARNING: NEUTROPENIA AND DIARRHEA

TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses.
CONTRAINDICATIONS

Severe hypersensitivity reaction to TRODELVY.
WARNINGS AND PRECAUTIONS

Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI.

Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤ Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.

Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.

Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤ 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.

Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.

Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.

ADVERSE REACTIONS

In the pooled safety population, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%).

In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.

In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes.

DRUG INTERACTIONS

UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY.

UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY.

Please see full Prescribing Information, including BOXED WARNING.

(Press release, Gilead Sciences, MAY 21, 2026, View Source [SID1234665969])

On May 21, 2026 Eikon Therapeutics, Inc. (Nasdaq: EIKN) ("Eikon"), a late-stage clinical biopharmaceutical company dedicated to developing innovative medicines to address serious unmet medical needs, reported the publication of full-text abstracts from its lead programs to be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago beginning on 29 May 2026. The six accepted presentations highlight clinical progress across Eikon’s pipeline, including the TLR7 and TLR8 dual-agonist EIK1001 trials in NSCLC and advanced melanoma, updated data for its highly selective PARP1 inhibitor EIK1003, and early development progress for the WRN inhibitor candidate EIK1005.

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"We look forward to presenting these data at the ASCO (Free ASCO Whitepaper) Annual Meeting, which reflect the breadth of our oncology pipeline and our focus on advancing novel therapeutic approaches across multiple mechanisms and treatment settings," said Roger M. Perlmutter, M.D., Ph.D., Chief Executive Officer and Board Chair of Eikon. "Our programs are evaluating both monotherapy and combination strategies in patients with advanced disease, with the goal of generating insights that can inform patient selection, optimize treatment approaches, and ultimately support future registration of these novel therapeutics."

2026 ASCO (Free ASCO Whitepaper) Abstract Titles and Presentation Details:

EIK1001

Title: Efficacy, safety and cytokine profiling with addition of the toll-like receptor (TLR) 7/8 dual agonist EIK1001 to Standard of Care First-Line Therapy: the Phase 2 TeLuRide-005 trial in Stage 4 Non-Small Cell Lung Cancer

Title: Adaptive Phase 2/3 Study of EIK1001, a TLR7/8 Dual Agonist, in Combination with Pembrolizumab, as First-Line Therapy in Participants with Advanced Melanoma (TeLuRide-006)

Title: A Phase 2/3 Study of EIK1001 in Combination with Pembrolizumab and Chemotherapy in Participants with Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008)

EIK1003

Title: EIK1003, a PARP1-selective inhibitor, in combination with paclitaxel (PTX): Initial combination and updated monotherapy results from a Phase 1/2 study EIK1003-001 in advanced solid tumors

EIK1005

Title: First-in-Human Study to Evaluate the Safety, Tolerability, and PK of EIK1005, a Novel WRN Inhibitor in Healthy Participants

Title: Phase 1/2 Study of the novel Werner helicase inhibitor EIK1005 as Monotherapy and in Combination with Pembrolizumab in Patients with Advanced Solid Tumors, including MSI-H or dMMR Tumors

(Press release, Eikon Therapeutics, MAY 21, 2026, View Source [SID1234665985])

On May 21, 2026 Convergent Therapeutics Inc., a clinical-stage biotechnology company developing next-generation alpha radiopharmaceuticals for cancer, reported the abstract release for its oral presentation on June 1, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting. The abstract describes interim results from Part 3 of the CONVERGE-01 Phase 2 trial of Ac-225 rosopatamab tetraxetan (CONV01-α) in patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously received Lu-177-PSMA radioligand therapy (Lu-PSMA).

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The CONVERGE-01 Part 3 dataset represents the largest prospective Phase 2 evidence for an alpha-emitting radiopharmaceutical in Lu-PSMA exposed patients. This population has grown substantially with the establishment of Lu-PSMA therapy in mCRPC care, for which no subsequent standard of care exists.

The full data, including antitumor activity, emerging durability, and tolerability — notably clinically- manageable hematopoietic toxicity without renal toxicity or high-grade xerostomia — will be presented by Michael J. Morris, MD, Prostate Cancer Section Head at Memorial Sloan Kettering Cancer Center.

"What will be presented at ASCO (Free ASCO Whitepaper) represents a meaningful step forward for patients navigating prostate cancer after Lu-PSMA therapy," said Phil Kantoff, MD, co-founder and CEO of Convergent Therapeutics. "CONVERGE-01 is a rigorous, prospective Phase 2 study evaluating CONV01-α in this growing Lu-PSMA-exposed population. We believe these data establish important benchmarks in this setting, and we look forward to its presentation at ASCO (Free ASCO Whitepaper)."

Based on the totality of the CONVERGE-01 data, Convergent is planning a pivotal Phase 3 study of CONV01-α in Lu-PSMA-exposed mCRPC patients beginning in mid 2027.

Demonstrated Tolerability Profile in a Heavily Pretreated Population

Patients enrolled in CONVERGE-01 Part 3 following extensive prior treatment exposure: all had received prior androgen deprivation therapy, androgen receptor pathway inhibitor therapy, and multiple cycles of Lu-PSMA therapy. Eighty percent of patients had also received prior taxane chemotherapy for mCRPC. Following treatment with CONV01-α, patients experienced a favorable safety and tolerability profile with clinically manageable hematopoietic toxicity, no renal toxicity, and no high-grade xerostomia.

Supply of Reliable, High-Quality Actinium-225

Actinium-225 supply has been a recognized constraint in the development of alpha radiopharmaceuticals, and reliable access to these radioisotopes is a prerequisite for late-stage development. Convergent has established a flexible, networked CMC process that allows for integration of multiple sources of Ac-225 from redundant suppliers and has secured Phase 3 supply via a recently expanded agreement with NorthStar Medical Radioisotopes for domestically supplied Ac-225 and co-located drug product manufacturing.

ASCO Presentation: Abstract Title: CONVERGE-01 Part 3: Ac-225 Rosopatamab Tetraxetan (CONV01-α) In Lu-PSMA Pretreated Metastatic Castration-Resistant Prostate Cancer (mCRPC).
Abstract Number: 5011
Format: Oral Presentation
Session Type/Title: Clinical Science Symposium – Radiation Re-Imagined: Radioligand Innovation in Prostate Cancer
Date and Time: June 1, 3:00 PM-4:30 PM CDT
Presenter: Michael J. Morris, MD, Prostate Cancer Section Head, Memorial Sloan Kettering Cancer Center

About the CONVERGE-01 Trial
The CONVERGE-01 trial is a Phase 2, randomized, open-label, multicenter three-part study designed to assess the safety and efficacy of CONV01-α in patients with mCRPC. In Part 1, patients received radiolabelled rosopatamab tetraxetan to characterize the biodistribution of the radioantibody to target organs and prostate cancer lesions. Participants were then enrolled in either Part 2 (dose optimization) or Part 3 (dose escalation) depending on their prior treatment history. Part 2 enrolled participants naïve to Lu-PSMA and Part 3 enrolled participants who were previously exposed to Lu-PSMA-radioligand therapy. Participants received CONV01-α in a two-dose regimen administered on Days 1 and 15. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT06549465.

About CONV01-α
CONV01-α is a PSMA-targeted Ac-225 radioantibody that pairs antibody precision with the localized potency of alpha radiation. CONV01-α, which is being developed to improve the treatment of mCRPC, uses a humanized monoclonal antibody directed against prostate-specific membrane antigen (PSMA), a well-established and highly expressed antigen in prostate cancer. CONV01-α is differentiated by its ability to precisely deliver actinium-225 (Ac-225) through this PSMA-targeting antibody, enabling short-range, high-energy alpha particle radiation that creates focused DNA damage within tumor cells while limiting exposure to surrounding tissues. Initial studies in more than 120 patients have established clinical proof-of-concept for CONV01-α, showing consistent antitumor activity and a differentiated safety profile. This selectivity, combined with strong tumor retention and minimal salivary and renal uptake, supports the potential of CONV01-α to be a clinically impactful therapy for PSMA-positive cancers.

(Press release, Convergent Therapeutics, MAY 21, 2026, View Source [SID1234665922])