On July 6, 2026 AbbVie (NYSE: ABBV) reported that the European Commission (EC) granted marketing authorization for TEPKINLY (epcoritamab) in combination with lenalidomide and rituximab (TEPKINLY + R2) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The approval is based on results from the pivotal Phase 3 EPCORE FL-1 trial, which evaluated fixed-duration TEPKINLY in combination with R2 compared to standard of care R2.

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"Follicular lymphoma is a persistent form of cancer that remains incurable, which means patients need more treatment options. Patients often relapse and experience shorter remissions and have fewer treatment options each time the disease returns," said Catherine Thieblemont, M.D., Ph.D., head of the hemato-oncology department, Paris Cité University, Hôpital Saint-Louis Assistance-Publique-Hopitaux de Paris (APHP) in Paris. "The results shown in the EPCORE FL-1 trial are clinically meaningful, demonstrating the potential for TEPKINLY + R2 to change the treatment paradigm for patients, offering the chance at a durable response with a chemotherapy-free option."

The marketing authorization is supported by data from the Phase 3 EPCORE FL-1 trial, an open-label interventional trial to evaluate the safety and efficacy of TEPKINLY + R2 compared to R2 alone in patients with R/R FL. The study demonstrated TEPKINLY + R2 reduced the risk of disease progression or death by 79% (HR 0.21, 95% CI: 0.13 – 0.33, p<0.0001) compared to R2 alone. The overall response rate (ORR) in patients treated with TEPKINLY + R2 was 96% (95% CI: 90.2, 98.6) compared to 81% in patients treated with R2 (95% CI: 72.7, 87.7; p<.0001). Among patients who were treated with TEPKINLY + R2, 74% achieved a complete response (CR) (n=181/243, 95% CI: 68.5, 79.8) compared to a 43% CR rate among patients treated with R2 (n=106/245, 95% CI: 37.0, 49.7).

The safety profile of TEPKINLY + R2 in the EPCORE FL-1 study was consistent with the known safety profiles of the individual regimens (epcoritamab and R2). In the trial, the most common (≥ 20%) adverse reactions were neutropenia, rash, upper respiratory tract infections, fatigue, diarrhea, injection site reactions, anemia, constipation, thrombocytopenia, cytokine release syndrome (CRS), hypogammaglobulinemia, COVID-19, pyrexia, and pneumonia. Serious adverse reactions occurred in 44% of patients who received epcoritamab in combination with lenalidomide and rituximab. Serious adverse reactions in ≥ 5% of patients included CRS, pneumonia, COVID-19, and febrile neutropenia.

"There remains a critical need for new treatment options to improve outcomes for patients with relapsed or refractory follicular lymphoma, particularly in earlier lines of therapy," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "This approval is important because it brings an effective treatment option to patients across Europe, representing meaningful progress for patients with follicular lymphoma."

FL is typically a slow-growing form of non-Hodgkin lymphoma (NHL) that arises from B-cell lymphocytes. FL is the second most common form of NHL overall, accounting for 20-30 percent of all NHL cases.1 FL incidence is significantly higher in European populations, 11-29 percent, compared to non-European populations, 2-18 percent.2 FL is considered incurable, and there is no standard of care treatment for third-line or later FL.1,3 Patients who achieve remission also often experience relapse.4,5,6

"A diagnosis of follicular lymphoma can bring a relentless cycle of disease recurrence and treatment," said Mitchell Smith, M.D., Ph.D., Chief Medical Officer of the Follicular Lymphoma Foundation. "The approval of epcoritamab now in combination with R2 in Europe is a welcome advance that will bring an innovative treatment option and hope to the follicular lymphoma community."

About the EPCORE FL-1 Trial
EPCORE FL-1 (NCT05409066) is a Phase 3 open-label interventional trial to evaluate the safety and efficacy of epcoritamab plus lenalidomide and rituximab (R2) versus R2 alone in patients with relapsed/refractory (R/R) follicular lymphoma (FL). The Phase 3 EPCORE FL-1 study included patients with relapsed or recurrent FL following at least one prior line of treatment across a broad range of patient characteristics and disease risk factors. Patients were randomized to receive epcoritamab in combination with R2 (n=243) or R2 alone (n=245). Patients received epcoritamab in 28-day cycles for a total of 12 cycles or until disease progression or unacceptable toxicity, whichever occurred first. Efficacy was established based on the dual primary endpoints of progression free survival (PFS) and overall response rate (ORR) determined by Lugano 2014 criteria as assessed by Independent Review Committee (IRC). Additional efficacy outcome measures include complete response (CR) and duration of response (DOR). The pivotal Phase 3 EPCORE FL-1 trial results were published in The Lancet in January 2026.

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.6

Epcoritamab (approved under the brand name EPKINLY in the U.S. and Japan, and TEPKINLY in the European Union) has received regulatory approval in certain lymphoma indications in more than 65 territories. Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration. The companies 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 relapsed or refractory (R/R) follicular lymphoma (FL) indication and additional approvals for the R/R diffuse large B-cell lymphoma (DLBCL) indication.

AbbVie and Genmab 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 several Phase 3, open-label, randomized trials, including a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658), and a trial evaluating epcoritamab in combination with lenalidomide and rituximab (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.

EU Indications and Important Safety Information about Tepkinly ▼ (epcoritamab)

Indications
Tepkinly (epcoritamab) as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Tepkinly in combination with lenalidomide and rituximab is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).

Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Important Safety Information

Contraindications
Hypersensitivity to the active substance or to any of the excipients.

Special warnings and precautions for use
Cytokine release syndrome (CRS)
CRS, which may be life-threatening or fatal, occurred in patients receiving Tepkinly. The most common signs and symptoms of CRS include pyrexia, hypotension and hypoxia. Other signs and symptoms of CRS in more than two patients include chills, tachycardia, headache and dyspnoea.
Most CRS events occurred in Cycle 1 and were associated with the first full dose of Tepkinly. Administer prophylactic corticosteroids to mitigate the risk of CRS. Patients should be monitored for signs and symptoms of CRS following Tepkinly administration. At the first signs or symptoms of CRS, institute treatment of supportive care with tocilizumab and/or corticosteroids as appropriate. Patients should be counselled on the signs and symptoms associated with CRS and patients should be instructed to contact their healthcare professional and seek immediate medical attention should signs or symptoms occur at any time. Management of CRS may require either temporary delay or discontinuation of Tepkinly based on the severity of CRS.

Haemophagocytic lymphohistiocytosis (HLH)
Haemophagocytic lymphohistiocytosis (HLH), including fatal cases, have been reported in patients receiving Tepkinly. HLH is a life-threatening syndrome characterised by fever, skin rash, lymphadenopathy, hepato- and/or splenomegaly and cytopenias. HLH should be considered when the presentation of CRS is atypical or prolonged. Patients should be monitored for clinical signs and symptoms of HLH. For suspected HLH, Tepkinly must be interrupted for diagnostic workup and treatment for HLH initiated. If HLH is confirmed, administration of Tepkinly should be discontinued.

Immune effector cell-associated neurotoxicity syndrome (ICANS)
ICANS, including fatal events, have occurred in patients receiving Tepkinly. ICANS may manifest as aphasia, altered level of consciousness, impairment of cognitive skills, motor weakness, seizures, and cerebral oedema. The majority of cases of ICANS occurred within Cycle 1 of Tepkinly treatment, however some occurred with delayed onset. Patients should be monitored for signs and symptoms of ICANS following Tepkinly administration. At the first signs or symptoms of ICANS treatment with corticosteroids and non-sedating-anti-seizure medicinal products should be instituted as appropriate. Patients should be counselled on the signs and symptoms of ICANS and that the onset of events may be delayed. Patients should be instructed to contact their healthcare professional and seek immediate medical attention should signs or symptoms occur at any time. Tepkinly should be delayed or discontinued as recommended.

Serious infections
Treatment with Tepkinly may lead to an increased risk of infections. Serious or fatal infections were observed in patients treated with Tepkinly in clinical studies. Administration of Tepkinly should be avoided in patients with clinically significant active systemic infections. As appropriate, prophylactic antimicrobials should be administered prior to and during treatment with Tepkinly. Patients should be monitored for signs and symptoms of infection, before and after Tepkinly administration, and treated appropriately. In the event of febrile neutropenia, patients should be evaluated for infection and managed with antibiotics, fluids and other supportive care, according to local guidelines.

Hypogammaglobulinaemia has also been reported in patients receiving Tepkinly. Immunoglobulin (Ig) levels should be monitored prior to and during treatment. Patients should be treated according to local institutional guidelines, including infection precautions and antimicrobial prophylaxis.

Cases of progressive multifocal leukoencephalopathy (PML), including fatal cases, have been reported in patients treated with Tepkinly who have also received prior treatment with other immunosuppressive medications. If neurological symptoms suggestive of PML occur during Tepkinly therapy, treatment with Tepkinly should be discontinued and appropriate diagnostic measures initiated.

Tumour Lysis Syndrome (TLS)
TLS has been reported in patients receiving Tepkinly. Patients at an increased risk for TLS are recommended to receive hydration and prophylactic treatment with a uric acid lowering agent. Patients should be monitored for signs or symptoms of TLS, especially patients with high tumour burden or rapidly proliferative tumours, and patients with reduced renal function. Patients should be monitored for blood chemistries and abnormalities should be managed promptly.

Tumour flare
Tumour flare has been reported in patients treated with Tepkinly. Manifestations could include localized pain and swelling. Consistent with the mechanism of action of Tepkinly, tumour flare is likely due to the influx of T-cells into tumour sites following Tepkinly administration. There are no specific risk factors for tumour flare that have been identified; however, there is a heightened risk of compromise and morbidity due to mass effect secondary to tumour flare in patients with bulky tumours located in close proximity to airways and/or a vital organ. Patients treated with Tepkinly should be monitored and evaluated for tumour flare at critical anatomical sites.

CD20-negative disease
There are limited data available on patients with CD20-negative DLBCL and patients with CD20-negative FL treated with Tepkinly, and it is possible that patients with CD20-negative DLBCL and CD20-negative FL may have less benefit compared to patients with CD20-positive DLBCL and patients with CD20-positive FL, respectively. The potential risks and benefits associated with treatment of patients with CD20-negative DLBCL and FL with Tepkinly should be considered.

Immunisation
Live and/or live-attenuated vaccines should not be given during Tepkinly therapy. Studies have not been conducted in patients who received live vaccines.

Fertility, pregnancy and lactation
Tepkinly is not recommended during pregnancy, while breast-feeding, and in women of childbearing potential not using contraception.

Effects on ability to drive and use machines
Tepkinly has a major influence on the ability to drive and use machines. Due to the potential for ICANS, patients receiving Tepkinly are at risk of altered level of consciousness. Patients should be advised to exercise caution while (or avoid if symptomatic) driving, cycling or using heavy or potentially dangerous machines.

Undesirable effects
Summary of the safety profile
Tepkinly Monotherapy
The safety of Tepkinly was evaluated in 382 patients with relapsed or refractory large B-cell lymphoma (N=167), FL (N=129) and FL (3-step step-up dose schedule N=86) after two or more lines of systemic therapy and included all the patients who enrolled to the 48 mg dose and received at least one dose of TEPKINLY. The most common adverse reactions (≥ 20%) were CRS, injection site reactions, fatigue, viral infection, neutropenia, musculoskeletal pain, pyrexia, and diarrhoea.
Serious adverse reactions occurred in 50% of patients. The most frequent serious adverse reaction (≥ 10%) was cytokine release syndrome (34%). Fourteen patients (3.7%) experienced a fatal adverse reaction (pneumonia in 9 (2.4%) patients, viral infection in 4 (1.0%) patients, and ICANS in 1 (0.3%) patient). Adverse reactions that led to discontinuation occurred in 6.8% of patients. Discontinuation of Tepkinly due to pneumonia occurred in 14 (3.7%) patients, viral infection in 8 (2.1%) patients, fatigue in 2 (0.5%) patients, and CRS, ICANS, or diarrhoea, in 1 (0.3%) patient each.
Dose delays due to adverse reactions occurred in 42% of patients. Adverse reactions leading to dose delays (≥ 3%) were viral infections (17%), CRS (11%), neutropenia (5.2%), pneumonia (4.7%), upper respiratory tract infection (4.2%), and pyrexia (3.7%).

Tepkinly in combination with lenalidomide and rituximab
The safety of Tepkinly in combination with lenalidomide and rituximab was evaluated in 243 patients with relapsed or refractory follicular lymphoma (FL) after one prior line of therapy (3-step step-up dose schedule N=133). The most common (≥ 20%) adverse reactions were neutropenia, rash, upper respiratory tract infections, fatigue, diarrhoea, injection site reactions, anaemia, constipation, thrombocytopenia, CRS, hypogammaglobulinaemia, COVID-19, pyrexia, and pneumonia.
Serious adverse reactions occurred in 44% of patients. Serious adverse reactions in ≥ 5% of patients included CRS, pneumonia, COVID-19, and febrile neutropenia. Adverse reactions that led to permanent discontinuation of Tepkinly occurred in 6.6% of patients. Discontinuation of Tepkinly in more than 1 patient included pneumonia, COVID-19, upper respiratory tract infections, and neutropenia.
Dose delays due to an adverse reaction occurred in 70% of patients. Adverse reactions which resulted in dose delays (≥ 5%) included neutropenia, upper respiratory tract infections, COVID-19, pneumonia, rash, and thrombocytopenia.

(Press release, AbbVie, JUL 6, 2026, View Source [SID1234669078])

On July 6, 2026 Genmab A/S (Nasdaq: GMAB) reported that the European Commission (EC) granted marketing authorization for TEPKINLY (epcoritamab) in combination with lenalidomide and rituximab (TEPKINLY + R2) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The approval is based on results from the pivotal Phase 3 EPCORE FL-1 trial that evaluated fixed-duration TEPKINLY + R2 compared to standard of care R2.

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"Follicular lymphoma is a persistent form of cancer that remains incurable, which means patients need more treatment options. Patients often relapse and experience shorter remissions and have fewer treatment options each time the disease returns," said Catherine Thieblemont, M.D., Ph.D., head of the hemato-oncology department, Paris Cité University, Hôpital Saint-Louis Assistance-Publique-Hopitaux de Paris (APHP) in Paris. "The results shown in the EPCORE FL-1 trial are clinically meaningful, demonstrating the potential for TEPKINLY + R2 to change the treatment paradigm for patients, offering the chance at a durable response with a chemotherapy-free option."

The marketing authorization is supported by data from the Phase 3 EPCORE FL-1 trial, an open-label interventional trial to evaluate the safety and efficacy of TEPKINLY + R2 compared to R2 alone in patients with R/R FL. The study demonstrated TEPKINLY + R2 reduced the risk of disease progression or death by 79% (HR 0.21, 95% CI: 0.13 – 0.33, p<0.0001) compared to R2 alone. The overall response rate (ORR) in patients treated with TEPKINLY + R2 was 96% (95% CI: 90.2, 98.6) compared to 81% in patients treated with R2 (95% CI: 72.7, 87.7; p<.0001). Among patients who were treated with TEPKINLY + R2, 74% achieved a complete response (CR) (n=181/243, 95% CI: 68.5, 79.8) compared to a 43% CR rate among patients treated with R2 (n=106/245, 95% CI: 37.0, 49.7).

The safety profile of TEPKINLY + R2 in the EPCORE FL-1 study was consistent with the known safety profiles of the individual regimens (epcoritamab and R2). In the trial, the most common (≥ 20%) adverse reactions were neutropenia, rash, upper respiratory tract infections, fatigue, diarrhea, injection site reactions, anemia, constipation, thrombocytopenia, cytokine release syndrome (CRS), hypogammaglobulinemia, COVID-19, pyrexia, and pneumonia. Serious adverse reactions occurred in 44% of patients who received epcoritamab in combination with lenalidomide and rituximab. Serious adverse reactions in ≥ 5% of patients included CRS, pneumonia, COVID-19, and febrile neutropenia.

"The marketing authorization of TEPKINLY + R2 by the European Commission represents a pivotal moment for individuals living with follicular lymphoma, providing a treatment option at first relapse, when effective intervention is critical," said Judith Klimovsky, M.D., Executive Vice President & Chief Development Officer of Genmab. "This milestone reinforces TEPKINLY’s potential as a core therapy across B-cell malignancies, validating its use in combination and earlier follicular lymphoma settings, while building upon its established efficacy as a monotherapy in advanced disease."

FL is typically a slow-growing form of non-Hodgkin lymphoma (NHL) that arises from B-cell lymphocytes. FL is the second most common form of NHL overall, accounting for 20-30 percent of all NHL cases.i FL incidence is significantly higher in European populations, 11-29 percent, compared to non-European populations, 2-18 percent.ii FL is considered incurable, and there is no standard of care treatment for third-line or later FL.i,iii Patients who achieve remission also often experience relapse.iv,v, vi

"A diagnosis of follicular lymphoma can bring a relentless cycle of disease recurrence and treatment," said Mitchell Smith, M.D., Ph.D., Chief Medical Officer of the Follicular Lymphoma Foundation. "The approval of epcoritamab now in combination with R2 in Europe is a welcome advance that will bring an innovative treatment option and hope to the follicular lymphoma community."

About the EPCORE FL-1 Trial
EPCORE FL-1 (NCT05409066) is a Phase 3 open-label interventional trial to evaluate the safety and efficacy of epcoritamab plus lenalidomide and rituximab (R2) versus R2 alone in patients with relapsed/refractory (R/R) follicular lymphoma (FL). The Phase 3 EPCORE FL-1 study included patients with relapsed or recurrent FL following at least one prior line of treatment across a broad range of patient characteristics and disease risk factors. Patients were randomized to receive epcoritamab in combination with R2 (n=243) or R2 alone (n=245). Patients received epcoritamab in 28-day cycles for a total of 12 cycles or until disease progression or unacceptable toxicity, whichever occurred first. Efficacy was established based on the dual primary endpoints of progression free survival (PFS) and overall response rate (ORR) determined by Lugano 2014 criteria as assessed by Independent Review Committee (IRC). Additional efficacy outcome measures include complete response (CR) and duration of response (DOR). The pivotal Phase 3 EPCORE FL-1 trial results were published in The Lancet in January 2026.

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.vi

Epcoritamab (approved under the brand name EPKINLY in the U.S. and Japan, and TEPKINLY in the European Union) has received regulatory approval in certain lymphoma indications in more than 65 territories. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies 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 relapsed or refractory (R/R) follicular lymphoma (FL) indication and additional approvals for the R/R diffuse large B-cell lymphoma (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 several Phase 3, open-label, randomized trials, including a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658), and a trial evaluating epcoritamab in combination with lenalidomide and rituximab (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.

(Press release, Genmab, JUL 6, 2026, View Source [SID1234669077])

On July 6, 2026 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, reported three-year landmark Phase 1b data from the fully enrolled C-800-01 cohort evaluating botensilimab (BOT), an Fc-enhanced multifunctional anti–CTLA-4 antibody, plus balstilimab (BAL), an anti–PD-1 antibody, in patients with refractory microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) without active liver metastases. The data were presented at the European Society for Medical Oncology Gastrointestinal Cancers (ESMO GI) Congress 2026 on July 2 in Munich, Germany.

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BOT+BAL demonstrated clinically meaningful long-term survival in a heavily pretreated patient population with historically limited benefit from conventional immune checkpoint inhibitors and few durable treatment options after progression on standard therapies. With extended follow-up, median overall survival was 21.2 months and the three-year overall survival rate was 33%, with the Kaplan-Meier curve showing a plateau beyond two years.

Available later-line standards in refractory MSS mCRC without active liver metastases have historically reported median overall survival of approximately 10–14 months in relevant analyses, reflecting a treatment setting in which few patients have historically remained alive at later landmark timepoints and pivotal studies have generally focused on median survival rather than mature 36-month overall survival outcomes.i In this context, the survival profile, curve plateau beyond two years, and proportion of patients alive and off systemic anticancer therapy support the durability of benefit observed with BOT+BAL in this fully enrolled 123-patient Phase 1b cohort.

The data build on the two-year overall survival results presented by Dr. Benjamin L. Schlechter of Dana-Farber Cancer Institute at ESMO (Free ESMO Whitepaper) GI 2025 and reflect an additional year of follow-up from the same cohort. With longer follow-up, the dataset now includes 26 confirmed responses; median duration of response was not reached; and 21 patients, or 17%, were alive and off all systemic anticancer therapy at last follow-up, including 13 responders.

"These three-year data are important because they show a pattern of benefit that is not typically expected in refractory MSS colorectal cancer," said Benjamin L. Schlechter, M.D., of Dana-Farber Cancer Institute and presenting author of the study. "These are patients who had received multiple prior lines of therapy and had few remaining options. Seeing a subset of patients remain alive and off systemic anticancer therapy after treatment speaks to the clinical relevance of these results and the potential for botensilimab plus balstilimab to change expectations for what immunotherapy may achieve in this setting."

"BOT+BAL is not simply another checkpoint combination; it was designed to activate antitumor immunity in tumors that have been difficult to reach with conventional immunotherapy," said Steven O’Day, M.D., Chief Medical Officer of Agenus. "With longer follow-up, we are seeing the elements that matter for a potentially differentiated immunotherapy regimen: durable survival, sustained responses, treatment-free intervals, and a manageable safety profile. These findings strengthen the foundation for BATTMAN and our broader development strategy in MSS colorectal cancer."

The Phase 1b (NCT03860272) cohort included 123 patients with MSS mCRC without active liver metastases. Patients had received a median of three prior lines of therapy; 67% had received at least three prior lines, 15% had received prior anti–PD-(L)1 with or without anti–CTLA-4 therapy, and 30% had received at least one later-line regimen of regorafenib, trifluridine/tipiracil with or without bevacizumab, or fruquintinib.

Key Efficacy Results:

Median overall survival: 21.2 months, with 24-month and 36-month overall survival rates of 41% and 33%, respectively
Confirmed objective response rate: 21%, including three complete responses and 23 partial responses
Median duration of response: not reached; responses ranged from 1.9 months to at least 37.4 months
Disease control rate: 69% at six weeks
Clinical benefit rate: 28% at 24 weeks
Tumor regression: observed in more than 40% of patients
Treatment-free survival: 21 patients or 17%, were alive and off all systemic anticancer therapy, including 13 responders with a subset of patients remaining free from subsequent therapy or death for more than two years
In a post hoc late-line–exposed subgroup of 37 patients who had received at least one prior regimen of regorafenib, trifluridine/tipiracil with or without bevacizumab, or fruquintinib, BOT+BAL showed a confirmed objective response rate of 22%, median overall survival of 16.2 months, and a three-year overall survival rate of 30%. In this subgroup, median duration of response was 16.6 months, disease control rate was 70%, and clinical benefit rate at 24 weeks was 27%.

Safety Results

With extended follow-up, no new safety signals were observed and there were no treatment-related deaths. Immune-mediated diarrhea/colitis resolved in 98% of affected patients, with a median time to resolution of 14 days from onset.

Treatment-related immune-mediated diarrhea/colitis was the most common immune-mediated adverse event (42%; grade ≥3, 15%). The selected Phase 3 regimen of BOT 1 mg/kg plus BAL demonstrated improved tolerability, with lower rates of immune-mediated diarrhea/colitis (27%; grade ≥3, 10%) than the 2 mg/kg regimen.

Together, the mature efficacy, treatment-free survival, and extended safety findings support continued evaluation of BOT+BAL in MSS mCRC and provide rationale for the ongoing randomized Phase 3 BATTMAN trial evaluating BOT+BAL in refractory MSS/proficient mismatch repair (pMMR) metastatic colorectal cancer.

Presentation Details

Abstract Title: Botensilimab + Balstilimab in Microsatellite-Stable Metastatic Colorectal Cancer Without Active Liver Metastases: Extended Follow-Up and 3-Year Survival
Presenter: Benjamin L. Schlechter, M.D.; Dana-Farber Cancer Institute, Boston, MA, USA
Final Publication Number: 91P
Congress: European Society for Medical Oncology Gastrointestinal Cancers Congress 2026
Location: ESMO (Free ESMO Whitepaper) GI, 2026 | Munich, Germany
Poster Availability: The poster is available on the Agenus publications page.

About the C-800-01 Study (NCT03860272)

C-800-01 is a first-in-human Phase 1b clinical trial evaluating botensilimab with or without balstilimab in patients with advanced solid tumors. The MSS mCRC without active liver metastases cohort enrolled 123 patients who received BOT 1 mg/kg or 2 mg/kg every six weeks plus BAL 3 mg/kg every two weeks. The primary endpoint was safety and tolerability. Secondary endpoints included objective response rate, duration of response, disease control rate, and progression-free survival. Exploratory endpoints included overall survival and clinical benefit rate.

(Press release, Agenus, JUL 6, 2026, View Source [SID1234669076])

On July 6, 2026 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a novel class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported an update across its pipeline of targeted alpha Radio-DARPin therapeutics (RDTs).

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"Molecular Partners has made significant progress in the first months of 2026, with our DLL3 radiotherapy candidate MP0712 progressing through Phase 1 initiation and dosing of patients in the first cohort. In addition, we have shown impressive data highlighting the unique advantages of our DARPins as interchangeable, isotope-agnostic vectors for alpha-emitting payloads, enabling us to tailor radiopharmaceuticals to target and disease biology. We look forward to first clinical data on MP0712 and to progressing our next Radio-DARPin candidates to first-in-human imaging in the second half of the year," said Patrick Amstutz, Ph.D., CEO of Molecular Partners.

Dosing of patients is ongoing in the first cohort of the US multicenter Phase 1/2a study of MP0712 (ClinicalTrials.gov: NCT07278479). MP0712, targeting the tumor-associated protein delta-like ligand 3 (DLL3) and carrying the therapeutic payload Lead-212 (212Pb), is being developed for patients with small cell lung cancer and other neuroendocrine cancers, with strategic partner Orano Med. The Phase 1 study contains up to 4 dose levels (cohorts). Each patient will receive up to 4 doses of MP0712 within their assigned dose level. At present five centers are open and recruiting. Initial data from the MP0712 Phase 1/2a study are expected within the next months, with a more comprehensive dataset on safety and efficacy in 2027.

Based on his successful experience with MP0712 and on access to other isotopes, Dr. Mike Sathekge of the Nuclear Medicine Research Institute (NuMeRI) in South Africa has made a request for an early-access clinical program (under the legal framework for compassionate care in South Africa, Section 21 of the Medicines and Related Substances Act) with a DLL3-targeting Radio-DARPin, this time utilizing 177Lu/225Ac as theranostics pair to image and treat patients, respectively (referred to as MP0714). Molecular Partners remains fully focused on the execution of the US Phase 1/2a study of MP0712 with 212Pb. PanTera, a leading radioisotope producer, is among the suppliers of 225Ac for the use of MP0714 at NuMeRI. This work is enabled by the versatility of DARPins to interchange isotopes.

The Company’s ability to explore targets in an alpha isotope-agnostic manner is supported by preclinical data presented at the 3rd Global Radiopharmaceuticals Development Summit in March 2026 in Shanghai, China. The data show highly comparable biodistribution profiles of two Radio-DARPin candidates, each specific for a different tumor target, labeled with 177Lu or 203Pb. Imaging with 177Lu can be indicative of behavior with the therapeutic isotope 225Ac, and similarly with 203Pb for 212Pb.

MP0726, the Company’s second Radio-DARPin candidate, targets mesothelin (MSLN), a tumor target overexpressed across several cancers with high unmet need such as ovarian cancer. Molecular Partners plans to advance MP0726 towards first-in-human imaging in H2 2026.

As part of its growing pipeline, the Company plans two INDs across its portfolio of targeted cancer therapeutics in 2027 and expects to nominate a new RDT target in the second half of this year.

(Press release, Molecular Partners, JUL 6, 2026, View Source [SID1234669075])

On July 6, 2026 Incyte (Nasdaq:INCY) reported that it has completed its acquisition of Vega Therapeutics, Inc., a wholly owned subsidiary of Star Therapeutics LLC. The acquisition adds VGA039, a novel monoclonal antibody in Phase 3 development for von Willebrand disease (VWD), the most common inherited bleeding disorder, to Incyte’s hematology portfolio.

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"With the acquisition complete, VGA039 adds one of the most promising late-stage hematology assets in development to our portfolio. As a potential first-in-class therapy, VGA039 is a strong strategic fit with our hematology franchise and expands our presence into bleeding disorders," said Bill Meury, Chief Executive Officer of Incyte. "Our priority is to advance the Phase 3 program, and we look forward to partnering with our talented new colleagues from Vega to progress VGA039 through clinical development."

VGA039 modulates Protein S to improve hemostasis, potentially improving the body’s ability to control bleeding in numerous bleeding disorders. VGA039 is in pivotal Phase 3 development for patients with VWD, the most common inherited bleeding disorder. If approved, VGA039 has the potential to be the first, once monthly subcutaneous prophylactic therapy for patients with VWD, who currently require frequent intravenous infusions.

VGA039 has received Breakthrough Therapy, Fast Track, orphan drug and rare pediatric disease designations from the U.S. Food and Drug Administration (FDA). VGA039 has advanced into the Phase 3 VIVID-6 study (NCT07115004), a global single arm cross-over study to investigate safety and efficacy of the subcutaneous administration of VGA039 as prophylaxis for bleeding in patients with every type of VWD, including those with a high disease burden.

As previously disclosed, under the terms of the parties’ stock purchase agreement, Incyte has acquired all outstanding shares of Vega Therapeutics, a wholly owned subsidiary of Star Therapeutics, for $1.25 billion upfront. Star Therapeutics will be eligible to receive up to $750 million in additional payments upon the achievement of sales milestones. We expect the transaction to be reflected as a one-time R&D expense in the third quarter and full year 2026 GAAP and non-GAAP financial results.

Lazard acted as financial advisor to Incyte, and Goodwin Procter LLP served as its legal counsel on the transaction. Evercore and Morgan Stanley acted as financial advisors to Star Therapeutics, and Fenwick & West LLP served as its legal counsel.

About VGA039
VGA039 is an investigational monoclonal antibody therapy with a novel mechanism of action that targets Protein S, with dual actions promoting platelet attachment and enhancing fibrin deposition to restore hemostasis. VGA039 has the potential to be a universal hemostatic therapy that can treat numerous bleeding disorders, starting with all types of von Willebrand disease (VWD) and bleeding sites. As a subcutaneously self-administered investigational antibody therapy with a convenient once monthly dosing regimen, VGA039 has the potential to improve convenience and quality of life for patients.

About von Willebrand Disease
Von Willebrand disease (VWD) is the most common inherited bleeding disorder in which the blood does not clot properly, caused by low or defective von Willebrand factor (VWF). VWD patients may experience excessive bleeding with varying severity and frequency, negatively impacting their daily lives. Current therapies for VWD prophylaxis include factor replacement therapies requiring multiple intravenous (IV) infusions every week. Approximately 135,000 people in the United States have been diagnosed with von Willebrand disease.

(Press release, Star Therapeutics, JUL 6, 2026, View Source [SID1234669074])