golcadomide (CC-99282) / BMS - LARVOL DELTA

Golcadomide ± Rituximab in Patients with Relapsed/Refractory Diffuse Large B–Cell Lymphoma: Updated Phase 1/2 Results (ICML 2025) - No abstract available

Clinical • P1/2 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

GOLSEEK–1: A Phase 3, Double–Blind, Randomized Study of Golcadomide + R–CHOP vs Placebo + R–CHOP in Patients with Previously Untreated, High–Risk, Large B–Cell Lymphoma (ICML 2025) - No abstract available

Clinical • P3 data • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Treatment Of newly-diagnosed Follicular Lymphoma with Rituximab, Golcadomide +/- Nivolumab- Interim analysis of the Phase II TOP-FLOR study (ICML 2025) - No abstract available

P2 data • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

GOLSEEK-2: A Phase 2 Randomized, Open-Label Study of Golcadomide in Combination with Rituximab in Participants with Newly Diagnosed Advanced-Stage Follicular Lymphoma (ICML 2025) - No abstract available

Clinical • Combination therapy • Metastases • P2 data • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

GOLSEEK-4: A MULTICENTER PHASE 3 RANDOMIZED OPEN-LABEL STUDY COMPARING EFFICACY AND SAFETY OF GOLCADOMIDE + RITUXIMAB VS INVESTIGATOR'S CHOICE IN PATIENTS WITH RELAPSED/REFRACTORY FOLLICULAR LYMPHOMA (EHA 2025) - P3 | "Commonly used treatment regimens for relapsed/refractory (R/R) FL include non-cross-resistant chemoimmunotherapy or rituximab (R)-lenalidomide (len)...Approximately 400 pts with R/R FL will be randomized 1:1 between GOLCA+R or IC, consisting of R-len or R-chemotherapy (CHOP or bendamustine)... GOLSEEK-4 will evaluate the safety and efficacy of GOLCA+R as a fixed duration, chemotherapy-free, outpatient treatment for R/R FL patients who have received >1 line of systemic therapy."

Clinical • P3 data • Follicular Lymphoma • Hematological Malignancies • Immune Modulation • Immunology • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Targeted Protein Degradation • CRBN • IKZF1

GOLCADOMIDE (GOLCA), A CEREBLON E3 LIGASE MODULATOR (CELMOD™) AGENT, ± RITUXIMAB (R) IN PATIENTS WITH RELAPSED/REFRACTORY (R/R) DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL): UPDATED PHASE 1/2 STUDY RESULTS (EHA 2025) - P1/2 | "With additional f/u, GOLCA+R continued to demonstrate a manageable safety profile with no new safety signals. Durable responses were shown in heavily pre-treated patients with R/R DLBCL. Responses were independent of cell of origin and tumor microenvironment status."

Clinical • IO biomarker • P1/2 data • Anemia • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Immune Modulation • Immunology • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Respiratory Diseases • Targeted Protein Degradation • BCL2 • CRBN • IKZF1 • TP53

Golcadomide, a Cereblon E3 Ligase Modulator (CELMoD™) Agent ± Rituximab, in Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL): Updated Phase 1/2 Results (ICML 2025) - No abstract available

Clinical • P1/2 data • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology • CRBN

GOLCADOMIDE (GOLCA), A CEREBLON E3 LIGASE MODULATOR (CELMOD™) AGENT ± RITUXIMAB (R), IN PATIENTS (PTS) WITH RELAPSED/REFRACTORY FOLLICULAR LYMPHOMA (R/R FL): UPDATED PHASE 1/2 STUDY RESULTS (EHA 2025) - P1/2 | "Primary objectives included safety and RP2D determination.As of 30 Dec 2024, 12 pts received GOLCA in Part A, and 22 and 38 received 0.2mg and 0.4mg GOLCA+R in Part B. In Part B, median time (range) from initial diagnosis was 59 mo (10-420), median prior Tx lines was 3 (1-12), 28% had prior T-cell-directed Tx, 30% had prior lenalidomide (len) and 30% were refractory to last Tx.In Part A, 4 pts completed 2 y of GOLCA, remaining in remission at last f/u; 8 discontinued (d/c) due to PD. With additional f/u, GOLCA continued to show promising efficacy with durable responses and no new safety signals. A higher ORR and similar tolerability were observed with GOLCA 0.4mg +R vs GOLCA and GOLCA 0.2mg +R, including in pts with prior len-based and/or T-cell-directed Tx. These data support continued development of GOLCA 0.4mg +R as a fixed-duration, chemo-free, outpatient option in R/R FL, to be evaluated in the Ph3 GOLSEEK-4 study."

Clinical • P1/2 data • Anemia • Febrile Neutropenia • Follicular Lymphoma • Immune Modulation • Immunology • Infectious Disease • Lymphoma • Neutropenia • Targeted Protein Degradation • CRBN • IKZF1

HP-001, AN ORAL IKZF 1/3 MOLECULAR GLUE, DEMONSTRATED SUPERIOR DEGRADATION POTENCY AND SPECIFITY IN THE PRE-CLINICAL MODEL (EHA 2025) - "Background: Immunomodulatory drugs (IMiDs) such as lenalidomide and pomalidomide, which hijack the CRBN E3 ligase to degrade IKZF1/3, remain central to hematologic malignancy treatment...Pre-clinical studies demonstrate HP-001's superior degradation potency and selectivity compared to approved IMiDs and next-generation candidates (e.g., mezigdomide, iberdomide, golcadomide, et al), overcoming resistance mechanisms while minimizing off-target effects... HP-001 is a highly potent and specific degrader of IKZF1/3, with marked antitumor activity as a single agent and in combination with dexamethasone. HP-001 is currently in phase 1 clinical trial for a variety of hematologic malignancies. CDE registration number: CTR20242943."

Preclinical • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Targeted Protein Degradation • CRBN • IKZF1

A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 (Golcadomide) in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3) (clinicaltrials.gov) - P1/2 | N=85 | Recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Aug 2029 ➔ Oct 2030 | Trial primary completion date: Dec 2025 ➔ Jan 2027

Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Golcadomide: Data readout from P3 GOLSEEK-4 trial (NCT06911502) for 2L+ follicular lymphoma in 2030 (Bristol-Myers Squibb) - Q1 2025 Results

P3 data • Follicular Lymphoma • Hematological Malignancies • Oncology

A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Choice in Participants With Relapsed/Refractory Follicular Lymphoma (GOLSEEK-4) (clinicaltrials.gov) - P3 | N=400 | Not yet recruiting | Sponsor: Celgene

New P3 trial • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

Golcadomide and Rituximab as Bridging Therapy for Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma Before CAR T-cell Therapy (clinicaltrials.gov) - P2 | N=41 | Recruiting | Sponsor: Mayo Clinic | Not yet recruiting ➔ Recruiting

Enrollment open • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type • Primary Mediastinal Large B-Cell Lymphoma • T Cell Histiocyte Rich Large B Cell Lymphoma • BCL2

CC-220-DLBCL-001: Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma (clinicaltrials.gov) - P1 | N=174 | Recruiting | Sponsor: Celgene | Trial completion date: Feb 2026 ➔ Jun 2027 | Trial primary completion date: Dec 2024 ➔ Jun 2027

Trial completion date • Trial primary completion date • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Leveraging efficiency metrics for the optimization of CELMoDs™ as cereblon-based molecular glue degraders. (PubMed, RSC Med Chem) - "We applied these efficiency metrics retrospectively to track optimization of a clinical molecular glue degrader series, resulting in the identification of Golcadomide (CC-99282). This work illustrates that efficiency metrics are beneficial for the identification of molecular glue drug candidates."

Journal • Targeted Protein Degradation • CRBN

Golcadomide and Rituximab as Bridging Therapy for Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma Before CAR T-cell Therapy (clinicaltrials.gov) - P2 | N=41 | Not yet recruiting | Sponsor: Mayo Clinic

New P2 trial • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type • Primary Mediastinal Large B-Cell Lymphoma • T Cell Histiocyte Rich Large B Cell Lymphoma • BCL2

FIL_RICCO: A Combination of Rituximab and CC-99282 As Front-line Therapy for Older Frail Patients with Diffuse Large B-cells Non-Hodgkin Lymphoma Evaluated with a Simplified Geriatric Assessment (sGA): a Phase II Study of the Fondazione Italiana Linfomi (FIL) (clinicaltrials.gov) - P2 | N=47 | Not yet recruiting | Sponsor: Fondazione Italiana Linfomi - ETS

New P2 trial • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

EPCORE NHL-5: A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma (clinicaltrials.gov) - P2 | N=622 | Recruiting | Sponsor: Genmab | Trial completion date:Jun 2031 ➔ Nov 2032 | Trial primary completion date: Jun 2031 ➔ Nov 2032

Adverse events • Trial completion date • Trial primary completion date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6 • CCND1 • CD20

Golcadomide: Data readout from P3 GOLSEEK-1 trial (NCT06356129) for high-risk 1L LBCL in 2028 (Bristol-Myers Squibb) - Q4 2024 Results: Data readout from P2 GOLSEEK-2 trial (NCT06425302) for newly diagnosed advanced stage 1L follicular lymphoma in 2026

P2 data • P3 data • Follicular Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Oncology

Golcadomide and Nivolumab in Patients with Non-Hodgkin Lymphoma with Refractory Disease After Chimeric Antigen T-cell Therapy (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: Natalie Galanina

New P1/2 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

EPCORE NHL-5: A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma (clinicaltrials.gov) - P2 | N=622 | Recruiting | Sponsor: Genmab | Trial completion date: Jun 2031 ➔ Nov 2032 | Trial primary completion date: Jun 2031 ➔ Nov 2032

Adverse events • Combination therapy • Trial completion date • Trial primary completion date • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6 • CCND1 • CD20

EPCORE NHL-5: A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma (clinicaltrials.gov) - P2 | N=622 | Recruiting | Sponsor: Genmab | Trial completion date: Nov 2032 ➔ Jun 2031 | Trial primary completion date: Nov 2032 ➔ Jun 2031

Adverse events • Combination therapy • Trial completion date • Trial primary completion date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6 • CCND1 • CD20

Longer Follow-up of Golcadomide (GOLCA), a Cereblon E3 Ligase Modulator (CELMoD™) Agent ± Rituximab (RTX), in Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) (ASH 2024) - "Compared to other immunomodulatory (IMiD) agents like lenalidomide, GOLCA has 10- to 100-fold enhanced antiproliferative and apoptotic activity in preclinical models of DLBCL due to greater efficiency at driving the closed active conformation of cereblon. These data support GOLCA + RTX as a convenient, well-tolerated, promising regimen in pts with R/R DLBCL, including those with prior CAR T cell and BiAb therapies. This study continues to enrol in Part B with other combination partners."

Clinical • Anemia • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Oncology • Pneumonia • Respiratory Diseases • Septic Shock • Targeted Protein Degradation • Thrombocytopenia • CRBN • IKZF1

Golseek-1: A Phase 3, Double-Blind, Randomized Study Comparing the Efficacy and Safety of Golcadomide Plus R-CHOP Vs R-CHOP in Patients with Previously Untreated, High-Risk, Large B-Cell Lymphoma (ASH 2024) - P3 | "Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP), typically administered for 6 cycles, is the standard therapy for DLBCL and is curative in ~60–70% of patients (pts)...In the phase 1b study CC-220-DLBCL-001, GOLCA combined with R-CHOP was well tolerated, showing promising activity and combinability with high rates of durable responses irrespective of cell of origin in pts with previously untreated aggressive BCL, including those with HR disease (Hoffmann et al...Patient follow-up will occur for up to approximately 67 months after beginning treatment. This study is recruiting at 293 sites in 37 countries, across the United States, Europe, Latin America, and East Asia."

Clinical • P3 data • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Burkitt Lymphoma • Diffuse Large B Cell Lymphoma • Epstein-Barr Virus Infections • Follicular Lymphoma • High-grade B-cell lymphoma • Indolent Lymphoma • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type • Targeted Protein Degradation • ALK • BCL2 • CRBN • IKZF1

Golcadomide-Mediated Degradation of Aiolos/Ikaros Synergizes with BET Inhibitors through Bidirectional Restructuring of the Directly Regulated Epigenetic Environment in DLBCL (ASH 2024) - "This agent exerts significant cell-autonomous anti-DLBCL activity in preclinical models and has demonstrated notable clinical efficacy in combination with Rituximab and R-CHOP in early clinical trials. Given the epigenetic mechanisms through which Aiolos/Ikaros derive their activity, we sought to explore combination strategies with other epigenetic agents, such as BMS-986158 (BMS-158), a selective BET inhibitor, to further enhance GOLCA's cell-autonomous activity...Conclusions : Through a genome-wide unbiased multi-omics approach, our results demonstrated that the synthetic lethal relationship between Ikaros/Aiolos and BRD4 in DLBCL depends, at least in part, on their ability to collaboratively sustain MYC expression by epigenetically stimulating the activities of its promoter and the MYC-activating enhancer. These findings suggest that combining GOLCA with a BET inhibitor may result in greater clinical efficacy through enhanced cell-autonomous activity in patients..."

Diffuse Large B Cell Lymphoma • Oncology • Targeted Protein Degradation • AURKA • BCL6 • BRD4 • CDKN1A • CRBN • IKZF1 • MYC • MYCN • PLK1