On May 21, 2026 Bristol Myers Squibb (NYSE: BMY) reported the presentation of data from its oncology portfolio and pipeline at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held May 29 – June 2 in Chicago, Illinois. Across more than 60 disclosures and 19 oral presentations, the Company will highlight progress from its differentiated oncology pipeline in solid tumors and hematologic malignancies.

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"This ASCO (Free ASCO Whitepaper) features the breadth of our oncology pipeline across multiple tumor types and different approaches such as bispecifics, ADCs and targeted therapies, and showcases the potential of our industry-leading CELMoD modality," said Cristian Massacesi, MD, executive vice president, chief medical officer and head of Development, Bristol Myers Squibb. "Throughout the meeting, we will also highlight novel combinations that we believe could offer innovative and meaningful options to people with cancer."

Key data to be presented by Bristol Myers Squibb and its collaborators include:

Delivering on the potential of targeted protein degradation with CELMoD (cereblon E3 ligase modulation) presentations in multiple myeloma and lymphoma

Late-breaking full results from the Phase 3 SUCCESSOR-2 trial of mezigdomide, an investigational, oral CELMoD, in combination with carfilzomib and dexamethasone (MeziKd) versus carfilzomib and dexamethasone in relapsed or refractory multiple myeloma will be shared in an oral presentation
Safety and 12-month efficacy results for golcadomide, a potential first-in-class investigational lymphoma CELMoD, in combination with pola-RCHP in patients with newly diagnosed aggressive B-cell lymphoma
Efficacy and safety of iberdomide, an investigational, oral CELMoD, in combination with daratumumab, bortezomib and dexamethasone in patients with newly diagnosed multiple myeloma
Exploring novel approaches across breast, gastric and lung cancers

Two Phase 3 studies sponsored by SystImmune’s parent company, Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin) in Mainland China:
Late-breaking Phase 3 data for izalontamab brengitecan (iza-bren), a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC), versus physician’s choice chemotherapy in patients with unresectable locally advanced, recurrent, or metastatic triple-negative breast cancer
Phase 3 results for iza-bren versus chemotherapy in patients with recurrent or metastatic esophageal squamous cell carcinoma
Outside of China, iza-bren is jointly developed by SystImmune and Bristol Myers Squibb
In partnership with BioNTech, the first global data for a PD-1 or PD-(L)1 x VEGF bispecific immunomodulator in previously untreated non-small cell lung cancer (NSCLC): Phase 2 data for pumitamig (PD-L1 x VEGF-A bispecific antibody) in combination with chemotherapy in first-line NSCLC
Expanding the evidence base for cell therapy and elevating real-world impact

Real-world patient characteristics, outcomes, and resource utilization of chimeric antigen receptor (CAR) T cell therapy across Foundation for the Accreditation of Cellular Therapy (FACT) and non-FACT treatment centers in large B-cell lymphoma
First results from the Center for International Blood and Marrow Transplant Research (CIBMTR) showing real-world outcomes of Breyanzi(lisocabtagene maraleucel) in patients with relapsed or refractory chronic lymphocytic leukemia and relapsed or refractory mantle cell lymphoma
More details on these select studies to be presented at the 2026 Annual Meeting by the Company and its collaborators:

Abstract Title

Author

Presentation

Type /

Abstract #

Session Title

Session

Date/Time

(CDT)

Breast Cancer

PANKU-Breast02: izalontamab brengitecan vs physician’s choice chemotherapy in patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC): A randomized, Phase 3 study (BL-B01D1-307)(LBA)

Wu, J

Oral

#LBA1003

Breast Cancer – Metastatic

June 2,

2026

9:45 AM –

12:45 PM

Gastrointestinal Cancer

PANKU-Esophagus01: izalontamab brengitecan vs chemotherapy in patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC), A multicenter, randomized, open-label, Phase 3 study (BL-B01D1-305)

Lu, Z

Oral

#4008

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

June 1,

2026

9:45 AM –

12:45 PM

Lymphoma

Golcadomide, a potential, first-in-class, oral CELMoD, + pola-RCHP in patients with newly diagnosed aggressive B-cell lymphoma: Safety and 12-month efficacy results

Hoffman, M

Oral

#7011

Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

May 29,

2026

1:00 PM –

2:30 PM

Real-world patient characteristics, outcomes, and resource utilization of chimeric antigen receptor (CAR) T cell therapy across Foundation for the Accreditation of Cellular Therapy (FACT) and non-FACT treatment centers in large B-cell lymphoma

Raj, R

Poster

#7023

Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

June 1,

2026

9:00 AM –

12:00 PM

Real-world outcomes of lisocabtagene maraleucel in patients with relapsed or refractory chronic lymphocytic leukemia: First results from CIBMTR

Tomasulo, E

Poster

#7024

Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

June 1,

2026

9:00 AM –

12:00 PM

Outcomes of lisocabtagene maraleucel in patients with relapsed or refractory mantle cell lymphoma: First real-world data from the CIBMTR

Huang, J

Poster

#7026

Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

June 1,

2026

9:00 AM –

12:00 PM

Multiple Myeloma

Efficacy and safety of iberdomide, daratumumab, bortezomib and dexamethasone in patients with newly diagnosed multiple myeloma

Kapoor, P

Oral

#7514

Hematologic Malignancies – Plasma Cell Dyscrasia

May 31,

2026

9:45 AM –

11:15 AM

Mezigdomide, carfilzomib, and dexamethasone vs carfilzomib and dexamethasone in relapsed or refractory multiple myeloma: Result from the Phase 3 SUCCESSOR-2 trial (LBA)

Richardson, P

Oral

#LBA7506

Hematologic Malignancies – Plasma Cell Dyscrasia

May 29,

2026

2:45 PM –

5:45 PM

Thoracic Cancer

Phase 2 data from ROSETTA Lung-02, a global randomized Phase 2/3 trial of pumitamig (PD-L1 x VEGF-A bsAB) + chemotherapy in 1L NSCLC

Peters, S

Rapid Oral

#8513

Lung Cancer – Non-Small Cell Metastatic

May 30,

2026

1:15 PM –

2:45 PM

BREYANZI

INDICATIONS

BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:
refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or
refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or
relapsed or refractory disease after two or more lines of systemic therapy.
Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.

adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. This indication is approved under accelerated approval based on 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).
adult patients with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy.
adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.
adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least 2 prior lines of systemic therapy.
IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids.
Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed.
T cell malignancies have occurred following treatment of hematologic malignancies with BCMA-and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI.
Cytokine Release Syndrome

Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. In clinical trials of BREYANZI, which enrolled a total of 769 patients with non-Hodgkin lymphoma (NHL), CRS occurred in 56% of patients, including ≥ Grade 3 CRS in 3.4% of patients. The median time to onset was 5 days (range: 1 to 63 days). CRS resolved in 99% of patients with a median duration of 5 days (range: 1 to 37 days). One patient had fatal CRS and 5 patients had ongoing CRS at the time of death. The most common manifestations of CRS (≥10%) were fever, hypotension, chills, tachycardia, hypoxia, and headache.

Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, diffuse alveolar damage, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).

Ensure that 2 doses of tocilizumab are available prior to infusion of BREYANZI.

Neurologic Toxicities

Neurologic toxicities that were fatal or life-threatening, including immune effector cell-associated neurotoxicity syndrome (ICANS), occurred following treatment with BREYANZI. Serious events including cerebral edema and seizures occurred with BREYANZI. Fatal and serious cases of leukoencephalopathy, some attributable to fludarabine, also occurred.

In clinical trials of BREYANZI, CAR T cell-associated neurologic toxicities occurred in 32% of patients, including ≥ Grade 3 cases in 10% of patients. The median time to onset of neurotoxicity was 8 days (range: 1 to 63 days). Neurologic toxicities resolved in 88% of patients with a median duration of 7.5 days (range: 1 to 119 days). Of patients developing neurotoxicity, 83% also developed CRS.

The most common neurologic toxicities (≥5%) included encephalopathy, tremor, aphasia, delirium, and headache.

CRS and Neurologic Toxicities Monitoring

Monitor patients daily for at least 7 days following BREYANZI infusion for signs and symptoms of CRS and neurologic toxicities and assess for other causes of neurological symptoms. Continue to monitor patients for signs and symptoms of CRS and neurologic toxicities for at least 2 weeks after infusion and treat promptly. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. Manage neurologic toxicity with supportive care and/or corticosteroid as needed. Advise patients to avoid driving for at least 2 weeks following infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic toxicity occur at any time.

Hypersensitivity Reactions

Allergic reactions may occur with the infusion of BREYANZI. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO).

Serious Infections

Severe infections, including life-threatening or fatal infections, have occurred in patients after BREYANZI infusion. In clinical trials of BREYANZI, infections of any grade occurred in 33% of patients, with Grade 3 or higher infections occurring in 12% of all patients. Grade 3 or higher infections with an unspecified pathogen occurred in 7%, bacterial infections in 3.5%, viral infections in 2%, and fungal infections in 0.7% of patients. One patient who received 4 prior lines of therapy developed a fatal case of John Cunningham (JC) virus progressive multifocal leukoencephalopathy 4 months after treatment with BREYANZI. One patient who received 3 prior lines of therapy developed a fatal case of cryptococcal meningoencephalitis 35 days after treatment with BREYANZI.

Febrile neutropenia developed after BREYANZI infusion in 8% of patients. Febrile neutropenia may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.

Monitor patients for signs and symptoms of infection before and after BREYANZI administration and treat appropriately. Administer prophylactic antimicrobials according to standard institutional guidelines. Avoid administration of BREYANZI in patients with clinically significant, active systemic infections.

Viral reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. In clinical trials of BREYANZI, 35 of 38 patients with a prior history of HBV were treated with concurrent antiviral suppressive therapy. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines.

Prolonged Cytopenias

Patients may exhibit cytopenias not resolved for several weeks following lymphodepleting chemotherapy and BREYANZI infusion. In clinical trials of BREYANZI, Grade 3 or higher cytopenias persisted at Day 29 following BREYANZI infusion in 35% of patients, and included thrombocytopenia in 25%, neutropenia in 22%, and anemia in 6% of patients. Monitor complete blood counts prior to and after BREYANZI administration.

Hypogammaglobulinemia

B-cell aplasia and hypogammaglobulinemia can occur in patients receiving BREYANZI. In clinical trials of BREYANZI, hypogammaglobulinemia was reported as an adverse reaction in 9% of patients. Hypogammaglobulinemia, either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion, was reported in 30% of patients. Monitor immunoglobulin levels after treatment with BREYANZI and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement as clinically indicated.

Live vaccines: The safety of immunization with live viral vaccines during or following BREYANZI treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during BREYANZI treatment, and until immune recovery following treatment with BREYANZI.

Secondary Malignancies

Patients treated with BREYANZI may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol-Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing.

Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS)

Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. Seven out of 769 (0.9%) patients with R/R NHL exposed to BREYANZI developed IEC-HS. Time to onset of IEC-HS ranged from 7 to 32 days. Of the 7 patients, 3 patients developed IEC-HS with overlapping occurrence of CRS and neurotoxicity, 2 patients developed IEC-HS with overlapping occurrence of neurotoxicity, and 1 patient developed IEC-HS with overlapping occurrence of CRS. IEC-HS was fatal in 2 of 7 patients. One patient had fatal IEC-HS and one had ongoing IEC-HS at time of death. IEC-HS is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of IEC-HS should be administered per current practice guidelines.

Adverse Reactions

The most common adverse reaction(s) (incidence ≥30%) in:

LBCL are fever, CRS, fatigue, musculoskeletal pain, and nausea. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, platelet count decrease, and hemoglobin decrease.
CLL/SLL are CRS, encephalopathy, fatigue, musculoskeletal pain, nausea, edema, and diarrhea. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, hemoglobin decrease, platelet count decrease, and lymphocyte count decrease.
FL is CRS. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, and white blood cell decrease.
MCL are CRS, fatigue, musculoskeletal pain, and encephalopathy. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, and platelet count decrease.
MZL is CRS. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, and white blood cell decrease.
Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.

(Press release, Bristol-Myers Squibb, MAY 21, 2026, View Source [SID1234665921])

On May 21, 2026 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported positive results from its Phase 2 trial of silevertinib in frontline (1L) non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) non-classical mutations (NCMs). These data will be presented by Julia Rotow, M.D., Clinical Director, Lowe Center for Thoracic Oncology at the Dana-Farber Cancer Institute, at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Saturday, May 30, 2026, 1:15 PM-2:45 PM CDT.

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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

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"Silevertinib continues to demonstrate potential to become a practice changing frontline therapy for NSCLC patients with EGFR-NCMs, delivering robust preliminary mPFS that far exceeds historical data for currently available therapies" said Sergey Yurasov, M.D., Ph.D., Chief Medical Officer of Black Diamond Therapeutics. "Importantly, silevertinib prevented the development of de novo brain metastases in this patient population, where progression via CNS metastases frequently occurs. We look forward to meeting with the FDA later this year to discuss our pivotal development plan."

"Patients with EGFR non-classical mutations represent a meaningful and underserved subset of NSCLC, with historically poor progression-free survival on available frontline TKIs," added Dr. Rotow. "The activity we are seeing with silevertinib across the full NCM spectrum, combined with its CNS activity, is highly encouraging, and I look forward to sharing these data with the oncology community at ASCO (Free ASCO Whitepaper) next week."

Silevertinib 1L NSCLC Phase 2 Results Summary

Results as of an April 11, 2026 data cutoff date include:

43 patients with 1L NSCLC were enrolled at a 200 mg once daily dose of silevertinib
Patients presented with a broad spectrum of EGFR-NCMs, including compound and P-Loop and C-Helix Compressing (PACC) mutations
19 patients with brain metastases, 7 of whom had measurable central nervous system (CNS) target lesions
11.2 months median follow-up

Durability
Preliminary median Progression-free Survival (mPFS) is 15.2 months (95% CI: 10.8; NE)
Median duration of response (DOR) had not been reached (95%CI: 7.0, NE)
23 of 43 patients (53%) remain on therapy, with longest at 23.5 months

CNS Activity
No patients developed de novo brain metastases
Previously disclosed CNS Objective Response Rate (ORR by RANO-BM) remained at 86%

ORR and DCR
Previously disclosed Objective Response Rate (ORR by RECIST 1.1) and Disease Control Rate (DCR) remained at 60% and 91%, respectively
Variant allele frequency (VAF) reduction observed in all evaluable patients across 25 unique EGFR-NCMs, including PACC

Safety
No new safety signals were observed
The rate of TRAEs > Grade 3 was reduced to 28% following dose reduction
Patients maintained or deepened clinical responses after dose reduction
Safety and efficacy data support 150 mg QD for pivotal development

ASCO Abstract: 8519
Title: Safety and efficacy results of the phase 2 study of silevertinib (BDTX-1535) in treatment-naïve patients with non-small cell lung cancer with non-classical EGFR mutations
Presenter: Julia Rotow, M.D., Clinical Director, Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute
Date and Time: May 30, 2026, 1:15 PM-2:45 PM CDT (slides will be available at the time of the presentation on the Black Diamond website)

Company Webcast Information
Black Diamond will hold a webcast for investors on Thursday, May 21, 2026 at 5:30 p.m. EDT. The webcast can be accessed under "Events and Presentations" on the Investors section of the Black Diamond website at www.blackdiamondtherapeutics.com.

About Silevertinib

Silevertinib is an investigational oral, covalent, brain-penetrant fourth-generation tyrosine kinase inhibitor (TKI) that selectively targets classical and more than 50 non-classical EGFR mutations in NSCLC. It is also designed to potently inhibit key EGFR alterations seen in GBM, including EGFRvIII, while avoiding the paradoxical EGFR activation reported with reversible TKIs. To date, over 200 patients with EGFR‑mutant NSCLC or EGFR‑altered GBM have been treated with silevertinib.

In addition to the ongoing Phase 2 trial of silevertinib in patients with EGFRm NSCLC, the Company also initiated a randomized Phase 2 trial of silevertinib in patients with newly diagnosed EGFRvIII-positive GBM (NCT07326566) in May 2026.

(Press release, Black Diamond Therapeutics, MAY 21, 2026, View Source [SID1234665920])

On May 21, 2026 Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported the presentation of initial data from the randomized Phase 2 trial (Duravelo-2) evaluating zelenectide pevedotin (zelenectide) in previously untreated patients with metastatic urothelial cancer (mUC), demonstrating encouraging response rates and a potentially differentiated safety profile both as a monotherapy and in combination with pembrolizumab. In addition, updated data from the Phase 1 trial (Duravelo-1) in previously untreated, cisplatin-ineligible mUC patients demonstrated encouraging median progression-free survival (PFS) comparable to published data for standard of care (SOC). The data announced today will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29 – June 2 in Chicago.

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"Despite recent advances for the treatment of bladder cancer, there remains an urgent need for more tolerable therapies. For instance, published clinical data for the current SOC for mUC demonstrate a significant number of tolerability-related drug discontinuations, and high rates of neuropathy and skin toxicities. In contrast, the initial Duravelo-2 data shared today demonstrate that zelenectide in combination with pembrolizumab continues to show response rates comparable to published data for SOC for mUC, while potentially offering substantially lower toxicity and improved tolerability for patients. We have now tested zelenectide as a monotherapy or in combination with pembrolizumab in more than 600 patients and have consistently observed lower rates and severity of neuropathy and skin toxicities," said Bicycle CEO Kevin Lee, Ph.D. "We believe that the extensive data we have generated in patients continue to demonstrate the unique nature of Bicycle molecules as targeting agents that offer a potentially differentiated tolerability profile to antibody-based approaches. We are excited to continue to explore these advantages with novel targets and novel payloads in our mission to help patients not only live longer but live well. Meanwhile, the Duravelo-2 trial has been converted into a randomized Phase 2 trial and we look forward to sharing further results in the second half of 2026."

Initial Duravelo-2 Data Results

Zelenectide is a Bicycle Drug Conjugate (BDC) targeting Nectin-4, a well-validated tumor antigen. The Duravelo-2 trial evaluated two doses of zelenectide – 5mg/m2 weekly (5mg dose) and 6mg/m2 (6mg dose) two weeks on, one week off – in combination with 200mg of pembrolizumab once every three weeks in previously untreated patients with mUC (Cohort 1). Bicycle reached regulatory alignment on the zelenectide 6mg dose as optimal both in combination with pembrolizumab and as a monotherapy. Cohort 1 data were extracted for the interim analysis at Week 27, on July 23, 2025. At the time of the data cut, the median PFS was not mature, and the results at the optimal dose showed:

65% (17/26) overall response rate (ORR) regardless of confirmation and blinded independent central review (BICR) confirmed ORR of 58% (15/26) at the 27-week cutoff. Subsequent to the 27-week cutoff, an additional confirmed BICR response was observed, which would result in an ORR of 62% (16/26).
Median duration of treatment (mDOT) was 6.3 months (0.7-10.6).
65% of patients remain on treatment.
Median relative dose intensity in patients receiving the optimal dose was 97%.
Low rates of zelenectide-related adverse events (AEs) of clinical interest were observed, including peripheral neuropathy, sensory (33%); skin reactions (17%); eye disorders (10%). There were no reported instances of zelenectide-related hyperglycemia.
No zelenectide-related severe skin reactions of any grade were reported.
The single Grade 3 zelenectide-related AE of clinical interest, peripheral neuropathy, resolved to Grade ≤1. There were no Grade 4 or Grade 5 zelenectide-related AEs of clinical interest.
Notably, only one patient at the optimal dose discontinued therapy due to a zelenectide-related AE at the time of the data cut in Cohort 1.
The Duravelo-2 trial also evaluated the 5mg dose and 6mg dose regimens of zelenectide as a monotherapy in mUC patients with one or more prior lines of systemic therapy (Cohort 2). Cohort 2 data were extracted for the interim analysis at Week 27, on June 14, 2025. At the time of the data cut, the median PFS was not mature, and the results at the optimal dose showed:

37% (10/27) ORR regardless of confirmation and 30% confirmed ORR (8/27) was achieved among efficacy-evaluable patients. Of the confirmed responses, 3 (11%) were complete responses (CRs) and 5 (19%) were partial responses (PRs).
mDOT was 4.8 months (1.3-10.1).
31% of patients remain on treatment.
Median relative dose intensity in patients receiving the optimal dose was 86%.
Low rates of zelenectide-related AEs of clinical interest were observed, including peripheral neuropathy (38%); skin reactions (28%); eye disorders (10%); and hyperglycemia (3%).
There were no Grade 4 or Grade 5 zelenectide-related AEs of clinical interest.
Notably, no zelenectide-related severe skin reactions of any grade were reported, and no treatment discontinuations occurred at the optimal dose.
The company plans to share additional Duravelo-2 data from the randomized Phase 2 trial in the second half of 2026.

Updated Duravelo-1 Data Results

The company also announced the presentation of updated Phase 1 Duravelo-1 data evaluating zelenectide in mUC, including monotherapy data in enfortumab vedotin (EV)-naïve patients and in combination with 200mg of pembrolizumab once every three weeks in previously untreated cisplatin-ineligible patients. Both cohorts evaluated zelenectide at the 5mg dose.

Updated results as of the August 1, 2025 data cutoff evaluating zelenectide in combination with pembrolizumab in previously untreated cisplatin-ineligible patients, 45% of whom were classified as Eastern Cooperative Oncology Group (ECOG) performance status of 2, showed:

59% (13/22) ORR regardless of confirmation, 50% confirmed ORR (11/22), and a disease control rate (DCR) of 82%. Of the confirmed responses, 5 (23%) were CRs and 6 (27%) were PRs.
Median PFS was 13.0 months and median duration of response (mDOR) was not mature at the time of the data cutoff.
Updated results as of the August 1, 2025 data cutoff evaluating zelenectide as a monotherapy in EV-naïve recurrent, unresectable mUC patients who had prior anti-programmed death-1/programmed death ligand-1 (PD-1/PD-L1), had disease progression after or were ineligible for platinum-based chemotherapy showed:

38% (20/53) ORR regardless of confirmation, 32% confirmed ORR (17/53) and a DCR of 66%. Of the confirmed responses, 2 (4%) were CRs and 15 (28%) were PRs.
Median PFS was 5.4 months and mDOR was 10.0 months (5.3-16.6) among patients with confirmed responses.
Across all patients, the safety and tolerability profile was consistent with other zelenectide data to date. No new safety signals were observed and there were no Grade 4 or Grade 5 zelenectide-related AEs of clinical interest reported.

The presentations will be made available in the Publications sections of the Bicycle Therapeutics website following each presentation.

(Press release, Bicycle Therapeutics, MAY 21, 2026, View Source [SID1234665917])

On May 21, 2026 Aulos Bioscience, a clinical-stage immuno-oncology company developing an immune-activating antibody therapeutic designed by leveraging an AI platform, reported positive Phase 2 data from its ongoing Phase 1/2 study of imneskibart in patients with doublet checkpoint inhibitor (CPI)-refractory metastatic melanoma. The data will be presented in a poster session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting in Chicago, Illinois.

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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

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The Phase 2 data show that imneskibart-based outpatient regimens are well tolerated and demonstrate durable clinical activity, including ongoing and deepening responses. Patients received either imneskibart plus low-dose, subcutaneous aldesleukin or the triplet regimen of imneskibart plus low-dose, subcutaneous aldesleukin and nivolumab. Across the study, imneskibart treatment was associated with sustained regulatory T cell (Treg) reduction, increased CD8/Treg ratios and evidence of durable anti-tumor activity, supporting its differentiated IL-2 mechanism.

"Imneskibart’s triplet regimen produced a 33% objective response rate and 67% disease control rate in metastatic melanoma patients whose disease progressed following earlier treatment with potent checkpoint inhibitor doublets," said Aron Knickerbocker, Aulos Bioscience’s President and Chief Executive Officer. "These patients urgently need safe, life-extending treatment options, particularly those who are not eligible for or do not receive TIL therapy. While lifileucel TIL therapy is the only FDA-approved product specifically indicated in the post-PD-1 setting, a substantial treatment gap remains. In addition to durable efficacy consistent with anti-tumor immune memory formation, imneskibart continues to demonstrate a differentiated, potentially best-in-class safety profile. These findings strongly support imneskibart’s mechanism and its ability to make a meaningful difference for patients."

As of the April 6, 2026 data cutoff, data were available from 83 patients across the Phase 1/2 study, including 12 patients in the Phase 2 melanoma triplet cohort evaluable for response:

Clinically meaningful activity observed with imneskibart triplet in doublet CPI-refractory melanoma

33% objective response rate (ORR) in confirmed doublet CPI-refractory cutaneous melanoma patients following prior anti-PD-1/CTLA-4 or anti-PD-1/LAG-3 therapy.
Four of 12 patients achieved partial responses, with target tumor reductions of 52%, 65%, 74% and 77%.
Four of 12 patients achieved stable disease, resulting in a 67% disease control rate.
Responses are ongoing and deepening, consistent with the potential generation of de novo anti-tumor immunity and immune memory formation; progression-free survival (PFS) and overall survival (OS) data continue to mature.
Strong signal of anti-tumor activity in imneskibart doublet regimen, with ongoing deep and durable tumor reductions in patients who progressed after receiving doublet CPI therapy (prior anti-PD-1 and anti-CTLA-4 and/or anti-PD-1 and anti-LAG-3)

14 evaluable patients received the imneskibart doublet regimen.
Three patients with the deepest target tumor reductions continued treatment beyond one year: one patient with a 48% tumor reduction continued on treatment for 13 months; another patient with a 58% reduction in measurable non-target tumors continued on treatment for 18.5 months; and a third patient with a complete response (100% reduction) in the target lesions continues on treatment for more than 25 months.
Imneskibart and low-dose, subcutaneous aldesleukin, with or without nivolumab, exhibits unique pharmacodynamic (PD), biological and pharmacokinetic (PK) effects in the IL-2 class, with a higher peripheral blood CD8/Treg ratio correlating with increased survival

Durable increases in CD8+ T cells and CD8/Treg ratios were observed in patients, with a corresponding decrease in Tregs.
PD data support hypothesis of selective effector cell expansion, validating imneskibart’s mechanism of action of redirecting interleukin-2 (IL-2) away from trimeric IL-2 receptors (expressed on Tregs and vasculature) and toward dimeric IL-2 receptors (on CD8+ T effector and natural killer cells).
The data show that imneskibart demonstrates durable activity coupled with a persistent reduction in Tregs and a higher CD8/Treg ratio that is associated with longer OS, PFS and time on treatment for patients.
PK data demonstrate sustained, selective signaling with a half-life of greater than 19 days, enabling potent immune activation without Treg expansion or high-dose IL-2 toxicities such as vascular leak syndrome or pulmonary edema.
Well-tolerated triplet regimen, with no apparent increase in Grade 3/4 adverse events following addition of nivolumab

Most drug-related adverse events were Grade 1 or 2; no patient discontinued treatment due to a drug-related adverse event.
The emerging safety profile of the triplet regimen is consistent with the known safety profiles of nivolumab and imneskibart plus aldesleukin, with no new toxicity signals observed.
Enrollment is complete in the Phase 2 doublet cohort evaluating imneskibart plus a single loading dose of low-dose, subcutaneous aldesleukin in patients with unresectable locally advanced or metastatic cutaneous melanoma following confirmed progression on doublet CPI therapy. Enrollment continues in the Phase 2 triplet cohort evaluating imneskibart plus low-dose, subcutaneous aldesleukin and nivolumab in approximately 20 evaluable second-line cutaneous melanoma patients, with plans advancing toward potential registrational development.

Two ongoing Phase 2 cohorts are evaluating imneskibart and low-dose, subcutaneous aldesleukin administered without and with avelumab (anti-PD-L1 with an active Fc domain and ADCC effector function) in patients with advanced PD-L1+ non-small cell lung cancer (NSCLC) that progressed on prior CPI therapy (with or without chemotherapy). Aulos anticipates presenting comprehensive clinical data from the NSCLC Phase 2 cohorts by year-end.

The poster, "Imneskibart + low-dose subcutaneous IL-2 ± nivolumab in patients with CPI-refractory cutaneous melanoma: Promising results from an ongoing phase 1/2 study," (Abstract 9526) will be presented live in the poster session "Melanoma/Skin Cancers" in the Exhibit Hall at McCormick Place on Sunday, May 31, 2026, 9:00 a.m. to 12:00 p.m. CDT. The poster will also be accessible to meeting registrants as an electronic poster on the ASCO (Free ASCO Whitepaper) online meeting platform.

To learn more about the imneskibart clinical trial program, please visit ClinicalTrials.gov (identifier: NCT05267626). For patients and providers in the U.S., please visit www.solidtumorstudy.com. For patients and health professionals in Australia, please visit www.solidtumourstudy.com.

About Imneskibart
Imneskibart (AU-007) is a human IgG1 monoclonal antibody designed by leveraging artificial intelligence that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, imneskibart redirects IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. Imneskibart also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

(Press release, Aulos Bioscience, MAY 21, 2026, View Source [SID1234665916])

On May 21, 2026 AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company advancing novel small molecule therapeutics derived from its boron chemistry platform, reported that Eric Easom, Co-Founder, Chairman, President and CEO will present at the 2026 Jefferies Global Healthcare Conference on June 4, 2026 at 12:50 PM ET, and members of management will be available for 1×1 meetings.

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A webcast can be accessed on the Investors section of the AN2 Therapeutics website at www.an2therapeutics.com. An archived replay will be available for at least 30 days following the presentation.

(Press release, AN2 Therapeutics, MAY 21, 2026, View Source [SID1234665915])