On December 9, 2024 Mendus AB ("Mendus" publ; IMMU.ST), a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, reported that it has presented positive survival data from the ongoing ADVANCE II Phase 2 trial at the ASH (Free ASH Whitepaper) 2024 conference (Press release, mendus, DEC 9, 2024, View Source [SID1234648904]). The data showed that the majority of AML patients treated with vididencel remain alive and disease-free in long-term follow-up, with a median follow-up of 41.8 months.

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AML is an aggressive blood-borne tumor which requires immediate chemotherapy to reduce the level of malignant blasts in bone marrow and blood. After chemotherapy, the risk of disease relapse due to residual cancer cells is high and the only potentially curative approach in AML is a hematopoietic stem cell transplant (HSCT, or "bone marrow transplant"). Mendus’ lead product vididencel is designed to stimulate active immunity against residual cancer cells. Active immunity, built up by the patient’s immune system, is the only long-lasting form of immunity. Mendus is developing vididencel as a maintenance therapy in AML, in order to improve disease-free and overall survival in patients who are in first complete remission following first-line chemotherapy.

"We are encouraged by the updated survival data presented at ASH (Free ASH Whitepaper) confirming that the majority of patients treated with vididencel as part of the ADVANCE II trial are alive today at a median follow-up of 41.8 months, with all patients having passed 3-year follow-up and two patients already 5-year follow-up." said Erik Manting, CEO of Mendus. "These data mark a significant milestone for Mendus, and support our accelerated preparations for a registration trial, bringing vidicencel to the final development stage before it can broadly reach patients in need. In parallel, we will look for opportunities to initiate additional trials, such as the ongoing AMLM22-CADENCE trial evaluating vididencel with oral azacitidine, in collaboration with the Australasian Leukaemia and Lymphoma Group. The preclinical data presented at ASH (Free ASH Whitepaper) further support the broader exploration of vididencel as a maintenance therapy in AML and potentially other blood-borne tumors, such as CML."

ADVANCE II data presented at ASH (Free ASH Whitepaper)
The ADVANCE II Phase 2 trial is an international multi-center Phase 2 trial evaluating vididencel as maintenance treatment for AML patients in first complete remission (CR1) following chemotherapy. Patients participating in the trial were ineligible for HSCT and had measurable residual disease (MRD), which is associated with increased relapse rates. The ADVANCE II trial has completed the active study phase of 70-week follow-up from the start of vididencel treatment and patients are now in long-term follow up.

The updated ADVANCE II data presented at ASH (Free ASH Whitepaper) show that 13 out of 20 patients treated with vididencel were alive and 11 patients were still in CR1 as of the November 4, 2024 cut-off-date, with a median follow-up of 41.8 months. Median relapse-free (RFS) and overall survival (OS) was not reached, as the majority of patients remained alive and disease-free. All patients had passed 3-year follow-up and 2 patients completed 5-year follow-up. The 1-year survival stood at 88%, 3-year survival at 71% and the estimated 5-year survival was 58%.

The only drug approved for post-chemo AML maintenance therapy is oral azacitidine, which in MRD-positive patients led to a median RFS of 7.1 months and a median OS of 14.6 months in the registration trial1. The estimated 3-year OS for the whole treated patient population which included MRD-positive and -negative patients was 37.4% and 5-year OS was 26.5%2.

(1Roboz et al. (2022) Blood; 139(4):2145, 2Wei et al., (2023) Am J Hematol 98: E84)

Immunomonitoring data from the ADVANCE II trial presented at ASH (Free ASH Whitepaper) demonstrated that patients with multiple T cell responses following vididencel treatment (sustained vaccine-induced responses, or sVIR) had a significantly better OS than patients without a sVIR (p=0.036) and a higher number of MRD responses, with 6 our of 9 patients showing MRD clearance or > 10-fold reduction in MRD level. There were also clear differences between patient groups at baseline. Particularly patients with high levels of B cells and low levels of inhibitory T cells showed significantly improved OS (p=0.0109) and the majority of these patients (6 out of 8) demonstrated sVIR following vididencel treatment. The data confirm that vididencel stimulates a broad, active immune response against residual disease, which is associated with improved clinical outcome.

"The data presented at ASH (Free ASH Whitepaper) confirm that vididencel acts as an active immunotherapy against residual cancer cells and has the potential to deliver durable clinical responses in AML. Combined with a strong safety profile, we believe this makes vididencel one of the most promising maintenance treatments currently in development in AML." said Jeroen Rovers, CMO of Mendus. "Based on the positive ADVANCE II data, we are executing on a clinical trial strategy aimed at market registration of vididencel in AML, while exploring opportunities to broaden the addressable patient population."

Other abstracts presented at ASH (Free ASH Whitepaper)
In addition to the ADVANCE II Phase 2 trial data in the post-chemotherapy maintenance setting, Mendus presented two abstracts based on preclinical data exploring the use of vididencel in additional patient populations. AML patients ineligible for high-intensity chemotherapy can be treated today with a combination of azacitidine (AZA) and venetoclax (VEN). In vitro data demonstrated that AZA and VEN do not interfere with vididencel’s mode of action and that VEN stimulates the processing of vididencel by antigen-presenting cells. In vivo data confirmed that vididencel and AZA+VEN act synergistically in a humanized mouse model for AML, supporting the clinical exploration of vididencel in AML patients treated with AZA+VEN. The second preclinical abstract addressed the potential use of vididencel in chronic myeloid leukemia (CML). Data showed that vididencel can stimulate cellular immunity against a CML cell line and investigated the combination potential of vididencel with different tyrosine kinase inhibitor drugs currently used for the treatment of CML. The possibility to improve immunity against residual cancer cells with vididencel addresses the need to improve treatment-free remission rates, allowing CML patients to control their disease without the need for life-long medication.
All data presented at ASH (Free ASH Whitepaper) are available on the Mendus corporate website via View Source

On December 9, 2024 Ichnos Glenmark Innovation (IGI), a global fully integrated clinical-stage biotech company developing multispecifics in oncology, reported first-time clinical data from the early dose-escalation portion of its Phase 1 study of ISB 2001 for the treatment of relapsed or refractory multiple myeloma (RRMM) (Press release, Ichnos Sciences, DEC 9, 2024, View Source;utm_medium=rss&utm_campaign=igi-presents_first-clinical_data_from-phase-1-study_of_trispecific_treat_antibody_isb-2001_showing_high_overall-response_rate_orr_with_durable_responses_and_favorable_safety_profile_in_pa [SID1234648903]). ISB 2001 is an investigational trispecific TREAT antibody for the treatment of RRMM that targets BCMA and CD38 on myeloma cells and CD3 on T cells. Initial results from 20 patients treated as of October 1, 2024, demonstrated an overall response rate (ORR) of 75% (15/20) across all doses tested (0.005 to 1.2 mg/kg), with a stringent complete remission (sCR) and complete remission (CR) rate of 20%. The ORR was 83% among the 18 patients treated at active doses (0.05 mg/kg and higher doses), including sCR/CR rate of 22%. The safety profile was mild with good tolerability, comparing favorably with first-generation 1+1 bispecifics.

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The data were presented today during an oral session at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, CA.

"The data presented today on ISB 2001 highlight its remarkable effectiveness as a novel trispecific-antibody T cell engager," said Professor Hang Quach, M.D., Professor of Haematology at the University of Melbourne and Director of Haematology at St Vincent’s Hospital Melbourne. "These results are among the most impressive I have seen in this patient population. ISB 2001 has the potential to revolutionize the treatment landscape for heavily pretreated patients with multiple myeloma who have exhausted currently approved therapies."

ISB 2001 was designed to enhance avidity with two binders targeting distinct myeloma-associated antigens – even at low expression levels – while offering improved safety compared to first-generation bispecific antibodies. IGI is developing ISB 2001 to meet the critical needs of RRMM patients, who have received prior T-cell directed therapies (including CAR-T cells and bispecifics).

"Early data based on only 20 patients are encouraging. ISB 2001 showed high clinical responses in a heavily pretreated and advanced patient population. Combined with a favorable safety and tolerability profile, these findings suggest ISB 2001 could represent a major advance in the treatment of RRMM in the future," said Lida Pacaud, M.D., Chief Medical Officer at IGI. "We are excited to advance the development of ISB 2001 by completing dose-escalation and moving swiftly into the dose-expansion part of the trial to establish the recommended Phase 2 dose and optimal dosing schedule."

ISB 2001 Phase 1 Dose Escalation Study Design

The Phase 1, first-in-human, open-label study is evaluating the safety and anti-myeloma activity of ISB 2001 in patients with RRMM (NCT05862012). The study is enrolling patients with RRMM who have been treated with immunomodulatory drugs, proteasome inhibitors, and anti-CD38 monoclonal antibodies and are refractory to, or intolerant of, established therapies known to provide clinical benefit in multiple myeloma. Patients with prior CAR-T cell therapies, bispecifics and/or prior BCMA targeted agents were eligible.

The study is being conducted in two parts: dose escalation and dose expansion. This dataset comes from patients treated in the dose escalation at six sites in the United States and Australia.

Preliminary ISB 2001 Phase 1 Dose Escalation Results

The early portion of the trial is evaluating the safety and anti-myeloma activity of ISB 2001. Twenty heavily pretreated patients with RRMM were enrolled as of October 1, 2024. These patients had received a median of 6 prior lines of therapy. Six patients (30%) had extra-medullary plasmacytomas, and 4 of the 12 patients assessed (33%) had high cytogenetic risk. Five (25%) patients were triple-refractory, 14 (70%) were penta-exposed, 2 (10%) were penta-refractory and 13 (65%) were refractory to the last therapy prior to study entry. About half of patients (n=9) had received bispecific antibodies, with other prior therapies including anti-BCMA targeted therapies (n=8), and CAR-T cell therapies (n=2).

ISB 2001 showed a favorable safety profile in patients with heavily pretreated RRMM. No dose-limiting toxicity was detected, and no adverse events led to treatment discontinuation. Grade 1 CRS was observed in 13 patients (65%), and only 2 patients (10%) experienced Grade 2. The median duration of CRS was 2 days (range: 1–8). No immune cell-associated neurotoxicity syndrome (ICANS) was observed. Injection site reactions were reported in 10 patients (50%), all Grade 1. Grade 3 infections were reported in 3 patients (15%).

In the 20 heavily pretreated patients, the ORR was 75% across all dose levels.

Responses to ISB 2001 at active doses (0.05 mg/kg or higher) were durable and deepened over time:

The ORR was 83% among the 18 patients which included stringent Complete Responses (sCRs) in 3 patients (17%), Complete Response in 1 patient (6%), Very Good Partial Responses (VGPRs) in 9 patients (50%), and Partial Responses (PRs) in 2 patients (11%).
The median time to first objective response was 36 days (range: 29–99).
16 patients (80%) remain on treatment at data cutoff.
Dose-proportional PK with long half-life of over 10 days and low immunogenicity (2/20 patients, 10% across all doses tested) support exploring less-frequent dosing than weekly subcutaneous administration.

T cell activation, proliferation and soluble BCMA reduction were observed in most patients at effective doses.

Potential Opportunity for ISB 2001

ISB 2001 was developed using IGI’s proprietary BEAT protein platform, which combines TCR interface-based heavy chain pairing and universal light chain technology to create multispecific antibodies. This innovative design can increase binding to tumor cells while minimizing on-target, off-tumor side effects and/or boost immune cell activity against tumor cells by triggering multiple signals.

"While there have been significant advancements in treatments for relapsed/refractory multiple myeloma, many patients still experience relapse. IGI designed ISB 2001 to offer a therapeutic option to patients who have previously received T-cell directed therapies including first-gen bispecific and CAR-T cell therapies." said Cyril Konto, M.D., President and CEO of IGI. "These results further validate IGI’s BEAT technology which addresses the stability and engineering bottlenecks that previously hindered the large-scale production of bispecific and multispecific antibodies."

On December 9, 2024 GSK plc (LSE/NYSE: GSK) reported that the National Medical Products Administration (NMPA) of China has accepted for review a new drug application (NDA) for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BVd) as a treatment for relapsed or refractory multiple myeloma (Press release, GlaxoSmithKline, DEC 9, 2024, View Source [SID1234648901]). Earlier this year, the NMPA granted priority review for this application as well as Breakthrough Therapy Designation1 for the BVd combination, which is intended to expedite development of investigational drugs with potential for substantial improvement over available therapies.

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Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: "Today’s regulatory filing acceptance, with a priority review, is a meaningful step forward in our efforts to bring the benefits of Blenrep in combination to patients in China. Multiple myeloma patients need new options that may improve outcomes, particularly at first relapse. The DREAMM-7 trial shows statistically significant efficacy, including overall survival and could redefine treatment in this patient population."

This is the seventh major regulatory filing acceptance this year for belantamab mafodotin in combination for the treatment of relapsed or refractory multiple myeloma based on the results of the DREAMM-7 and DREAMM-8 trials. In 2024, belantamab mafodotin combinations have been accepted for review in the US3, European Union4, Japan5 (with priority review), United Kingdom, Canada and Switzerland (with priority review for DREAMM-8).

The application is based on the interim results of the phase III head-to-head DREAMM-7 trial, which met its primary endpoint, showing statistically significant and clinically meaningful improvement in progression-free survival (PFS) for BVd compared to daratumumab plus bortezomib and dexamethasone (DVd) in relapsed or refractory multiple myeloma. In a subsequent planned interim analysis, the DREAMM-7 trial met the key secondary endpoint of overall survival (OS), showing that BVd significantly reduced the risk of death versus standard of care DVd.

About multiple myeloma
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.6,7 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year.8 In China, multiple myeloma is a growing health concern with approximately 30,000 new cases each year.9 The incidence of multiple myeloma in China has doubled and mortality has increased 1.5-fold in the past three decades.10 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.11

About DREAMM-7
The DREAMM-7 phase III clinical trial is a multicentre, open-label, randomised trial evaluating the efficacy and safety of belantamab mafodotin in combination with bortezomib plus dexamethasone (BVd) compared to a combination of daratumumab and bortezomib plus dexamethasone (DVd) in patients with relapsed/refractory multiple myeloma who previously were treated with at least one prior line of multiple myeloma therapy, with documented disease progression during or after their most recent therapy.

A total of 494 participants were randomised at a 1:1 ratio to receive either BVd or DVd. Belantamab mafodotin was scheduled to be dosed at 2.5mg/kg intravenously every three weeks.

The primary endpoint is PFS as per an independent review committee. The key secondary endpoints include OS, duration of response (DOR), and minimal residual disease (MRD) negativity rate as assessed by next-generation sequencing. Other secondary endpoints include overall response rate (ORR), safety, and patient reported and quality of life outcomes.

Results from DREAMM-7 were first presented12 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Plenary Series in February 2024, shared in an encore presentation at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, and published in the New England Journal of Medicine.

About Blenrep
Blenrep is an antibody-drug conjugate comprising a humanised B-cell maturation antigen monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group.

Blenrep is approved as monotherapy in Hong Kong. Refer to the local Summary of Product Characteristics for a full list of adverse events and complete important safety information.

On December 9, 2024 Genmab A/S (Nasdaq: GMAB) reported new long-term results from two ongoing clinical trials evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, in adult patients with diffuse large B-cell lymphoma (DLBCL) (Press release, Genmab, DEC 9, 2024, View Source [SID1234648900]). Results from Arm 1 of the Phase 1b/2 EPCORE NHL-2 trial (NCT04663347), evaluating fixed-duration epcoritamab in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP), demonstrated an overall response rate (ORR) of 100 percent and a complete response (CR) rate of 87 percent in high-risk patients (n=46) with previously untreated DLBCL. Among complete responders, 83 percent remained in remission after two years. Separately, results from the Phase 2 EPCORE NHL-1 trial (NCT03625037), evaluating epcoritamab monotherapy in challenging-to-treat adult patients (n=157) with relapsed or refractory (R/R) large B-cell lymphoma (LBCL; including 148 patients with R/R DLBCL), showed that among the 41 percent of patients who achieved a CR, an estimated 52 percent were still responding at three years (median CR duration: 36.1 months). Both analyses were presented at the 66th Annual Meeting and Exposition of the American Society of Hematology (ASH) (Free ASH Whitepaper).

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"The unprecedented durability of response seen in these data reinforce the potential of epcoritamab to become a core therapy for the treatment of multiple B-cell malignancies to benefit more patients," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "These results support our ongoing Phase 3 trials for epcoritamab, including as an investigational first-line combination therapy in patients with previously untreated diffuse large B-cell lymphoma."

EPCORE NHL-2 Results in First-Line DLBCL (Abstract #581)
The EPCORE NHL-2 trial enrolled 46 patients considered to have high-risk DLBCL, identified by International Prognostic Index (IPI) scores of 3 to 5, a range associated with poor long-term outcomes. The IPI is a key tool used by oncologists to predict the prognosis of aggressive B-cell lymphomas.i At screening, 35 percent of patients (n=16) had bulky disease (>10 cm) and 21 percent (n=6) of evaluable patients (n=28) had double-hit/triple-hit LBCL based on gene rearrangements identified by central analysis.

With a median follow-up of 27.4 months (range, 0.8-33.9), 87 percent of patients remained alive at two years and 74 percent were progression free.
At two years, a minimal residual disease (MRD) analysis showed MRD negativity was achieved in 91 percent of evaluable patients (30/33), indicating no detectable disease.
Epcoritamab in combination with R-CHOP is being studied further in the ongoing, randomized, Phase 3 EPCORE DLBCL-2 trial (NCT05578976).

"More first-line treatment options for diffuse large B-cell lymphoma are needed, especially for patients with aggressive disease prognostic markers that may impact the efficacy of current standard first-line therapies," said Lorenzo Falchi, MD, Lymphoma Specialist, Department of Medicine, Memorial Sloan Kettering Cancer Center.ii "Relapse rates with the R-CHOP treatment regimen can reach 50 percent, so the durable responses observed in the study suggest significant potential for this first-line epcoritamab-based combination."

The most common treatment-emergent adverse events (TEAEs) were neutropenia (70 percent), anemia (69 percent), cytokine release syndrome (CRS; 60 percent), fatigue (49 percent), nausea (47 percent), pyrexia (42 percent), and injection-site reaction (40 percent). Four patients (9 percent) discontinued epcoritamab due to TEAEs; fatal TEAEs occurred in two patients (COVID-19 and septic shock). CRS events were mostly low grade (45 percent Grade 1, 11 percent Grade 2, 4 percent Grade 3) and mainly occurred after the first full dose. All CRS cases resolved, and none led to discontinuation. Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in two patients (one Grade 1; one Grade 2) and resolved in a median of 2.5 days without leading to discontinuation.

Use of epcoritamab + R-CHOP in first-line DLBCL is not approved in the U.S. or in the EU or in any other territory. The safety and efficacy of epcoritamab for use as a combination therapy in DLBCL have not been established.

EPCORE NHL-1 Results in Third-Line LBCL (Abstract #4480)
Three-year follow-up results from the Phase 2 EPCORE NHL-1 trial evaluated epcoritamab monotherapy in 157 patients with R/R LBCL and demonstrated that epcoritamab continues to deliver durable responses in challenging-to-treat patients.

The ORR was 59 percent, and the CR rate was 41 percent. Median duration of response was 20.8 months (95 percent CI, 13.0-32.0) and median duration of CR was 36.1 months (95 percent CI, 20.2 to not reached [NR]).
52 percent of patients who experienced a CR were still responding at three years (median CR duration: 36.1 months).
Of the 119 patients who were MRD-evaluable, 54 (45 percent) achieved MRD-negativity. In a cycle 3-day 1 landmark analysis, 3-year PFS rates were 52 percent among MRD-negative patients and 18 percent among MRD-positive patients.

The most common TEAEs were CRS (51 percent; 32 percent Grade 1, 16 percent Grade 2, 3 percent Grade 3), fatigue (25 percent), and pyrexia (25 percent); CRS rates remained unchanged since prior reports. Fatal TEAEs were reported in 20 patients; 10 patients had Grade 5 COVID-19 (including COVID-19 pneumonia). Seventy-three percent of patients treated with epcoritamab for two or more years did not experience a Grade 3 or higher infection after two years (median follow-up after 2 years, 12.3 months). Incidence of Grade 3 or higher cytopenias was highest (27 percent) during the first eight weeks of treatment and rates were within 0-13 percent in subsequent 12-week time periods up to week 144. Immunoglobulin G levels decreased by a median of approximately 20 percent after the start of epcoritamab treatment (baseline median, 540.0 mg/dL) and remained stable over time.

About Diffuse Large B-Cell Lymphoma (DLBCL)
DLBCL is the most common type of non-Hodgkin’s lymphoma (NHL) worldwide, accounting for approximately 25-30 percent of all NHL cases.iii,iv In the U.S., there are approximately 25,000 new cases of DLBCL diagnosed each year.v DLBCL can arise in lymph nodes as well as in organs outside of the lymphatic system, occurs more commonly in the elderly and is slightly more prevalent in men.vi,vii DLBCL is a fast-growing type of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. For many people living with DLBCL, their cancer either relapses, which means it may return after treatment, or becomes refractory, meaning it does not respond to treatment. Although new therapies have become available, treatment management can remain a challenge. viii,ix

About the EPCORE NHL-2 Trial
EPCORE NHL-2 is a Phase 1b/2 open-label interventional trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics/biomarkers, immunogenicity, and preliminary efficacy of epcoritamab as a monotherapy and in combination with other standard of care agents in patients with B-cell non-Hodgkin’s lymphoma (B-NHL). The trial consists of two parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). The primary objective of Part 1 is safety, and the primary goal of Part 2 is preliminary efficacy. The primary endpoint was overall response rate (ORR) based on best overall response per Lugano criteria. MRD negativity was assessed as a secondary endpoint.

Arm 1 of the trial is epcoritamab plus rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL). More information on this trial can be found at View Source (NCT: 04663347).

About the EPCORE NHL-1 Trial
EPCORE NHL-1 is an open-label, multicohort, single-arm, Phase 1/2 trial of epcoritamab in participants with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL). The trial was conducted at 88 sites across 15 countries and consisted of three parts: a Phase 1 first-in-human, dose escalation part; a Phase 2a expansion part; and a Phase 2a dose optimization part. More information on this trial can be found at View Source (NCT: 03625037).

About Epcoritamab
Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.x

Epcoritamab (approved under the brand name EPKINLY in the U.S. and Japan, and TEPKINLY in the EU) has received regulatory approval in certain lymphoma indications in several territories. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication.

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes five ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigator’s choice chemotherapy (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL (NCT05409066), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744), and a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.

On December 9, 2024 EnnoDC, a clinical-stage biotech company pioneering the design and development of first-in-class Dendritic Cell-targeting immunotherapies, reported that new preliminary data of a Phase I/IIa clinical study evaluating its immunotherapy candidate CD40 (Press release, EnnoDC, DEC 9, 2024, View Source [SID1234648898]). HVac in patients with human papillomavirus (HPV16)-associated oropharyngeal carcinoma (OPC), will be presented at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2024, 11-13 December 2024 in Geneva, Switzerland.

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The poster titled, "Preliminary results of a multicentric randomized Phase I/IIa trial of an immunotherapy targeting dendritic cells (DC), CD40.HVac, in patients with HPV16-positive oropharyngeal carcinoma (OPC)", will be presented byDr Caroline Even, Department Head of the Head and Neck Medical Oncology Unit at Gustave Roussy, on Thursday, 12 December during the poster display session in the foyer mezzanine from 12:30 – 13:30 CET (see the abstract online).

EnnoDC’s first-in-class approach combines the power of vaccines and immunotherapy antibodies to provide targeted immune responses for both cancer and infectious diseases. CD40.HVac is an immunotherapy candidate targeting the E6/E7 antigens of the virus in patients with HPV16+ OPC, the most common form of this disease which accounts for more than 60% of Head & Neck cancers. It is currently evaluated in a Phase I/II multicentric double-blind placebo-controlled dose escalation trial (NCT06007092). The study is being conducted by Gustave Roussy Cancer Campus, European first cancer center.

Christophe Hubert, Chief Executive Officer of EnnoDC, commented:

"These preliminary data provide the first clinical results of our technology inducing HPV-specific CD4+ and CD8+ T cells and showcase for the first time our new immunotherapies which are under development for the treatment of HPV-induced cancers and prostate cancer. We look forward to reporting upcoming results from this trial in the coming months and taking the next steps to develop a new class of treatments for patients that fail to respond to available immunotherapies."

Details of the poster presentation are:

Abstract title: Preliminary results of a multicentric randomized Phase I/IIa trial of an immunotherapy targeting dendritic cells (DC), CD40HVac, in patients with HPV16-positive oropharyngeal carcinoma (OPC)
Presenter: Dr Caroline Even, Department Head of the Head and Neck Medical Oncology Unit at Gustave Roussy

Date/Time: 12 December 2024, 12:30 -13:30 pm CET

Location: Palexpo exhibition centre, Foyer Mezzanine

The ESMO (Free ESMO Whitepaper) IO poster will be available on ENNODC’s corporate website after the poster sessions have been opened.