Efficacy and Safety Study of Acasunlimab as Monotherapy and in Combination With Pembrolizumab in Subjects With Relapsed/Refractory, Unresectable Locally Advanced or Metastatic Cutaneous Melanoma That Progressed On or After Treatment With a Checkpoint Inhibitor (ABBIL1TY MELANOMA-07)

The goal of this clinical trial is to learn about the effectiveness and safety of the bispecific antibody acasunlimab (also known as DuoBody®-PD-L1x4-1BB) when given either alone or together with the cancer drug pembrolizumab in participants with locally advanced or metastatic melanoma of the skin. All participants will receive active drugs; no one will be given a placebo.
The trial duration will be approximately 15 months for each participant, including a 28-day screening period and estimated 4-month treatment and 10-month follow-up periods; however, the duration of the treatment and follow-up periods may vary for each participant.
Participants will have regular check-ups while on treatment, with visits every week initially, and then every 3 weeks later in the trial.

Start Date30 Jun 2025

Sponsor / Collaborator

Genmab A/S

NCT06635824

/ RecruitingPhase 3

A Prospective, Open-Label, Randomized, Phase 3 Trial of Acasunlimab (GEN1046) in Combination With Pembrolizumab Versus Docetaxel in Subjects With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer After Treatment With a PD-1/PD-L1 Inhibitor and Platinum-Containing Chemotherapy (ABBIL1TY NSCLC-06)

This is a multicenter, randomized, open-label, international, Phase 3 trial to evaluate the efficacy and safety of acasunlimab in combination with pembrolizumab versus docetaxel (standard of care) in participants with programmed death ligand 1 (PD-L1)-positive metastatic non-small cell lung cancer (NSCLC) who have been treated with programmed cell death protein 1 (PD-1)/PD-L1 inhibitor and platinum-containing chemotherapy, administered either in combination or sequentially in the metastatic setting.

Start Date25 Nov 2024

Sponsor / Collaborator

Genmab A/S

[+1]

NCT06046274

/ WithdrawnPhase 2

A Phase 2 Exploratory, Multicenter, Open-Label Trial to Determine the Safety and Preliminary Clinical Activity of GEN1046 in Combination With Anticancer Agents in Subjects With Advanced Endometrial Cancer

The goal of this clinical study is to learn about the bispecific antibody, acasunlimab (also known as GEN1046) in combination with the cancer drug pembrolizumab for treatment of participants with incurable endometrial cancer (cancer of the womb). The main questions the study aims to answer are:
* How well acasunlimab in combination with pembrolizumab works against endometrial cancer
* What are the potential side effects participants may experience when they are treated with acasunlimab in combination with pembrolizumab
Participants will receive both acasunlimab and pembrolizumab. All participants will receive active drug; no one will receive placebo. participants will participate in 1 of 2 cohorts. A participant will receive study treatment up to a maximum of 24 months. The study duration (including screening, treatment, and follow-up) for each participant will be about 39 months.

Start Date01 Oct 2023

Sponsor / Collaborator

Genmab A/S

[+1]

100 Clinical Results associated with Acasunlimab

100 Translational Medicine associated with Acasunlimab

100 Patents (Medical) associated with Acasunlimab

Literatures (Medical) associated with Acasunlimab

01 Apr 2025·Journal for ImmunoTherapy of Cancer

Acasunlimab, an Fc-inert PD-L1×4-1BB bispecific antibody, combined with PD-1 blockade potentiates antitumor immunity via complementary immune modulatory effects

Article

Author: Costa Sa, Carol ; Spires, Vanessa M ; Fereshteh, Mark ; Nürmberger, Kristina B ; Sahin, Ugur ; Capello, Michela ; Muik, Alexander ; Türeci, Özlem ; Strumane, Kristin ; Sette, Angelica ; Pencheva, Nora ; Burm, Saskia M ; Ahmadi, Tahamtan ; Yu, Christina ; Toker, Aras ; de Andrade Pereira, Bruna ; Jure-Kunkel, Maria ; Blum, Jordan M ; Higgs, Brandon W ; Plantinga, Theo ; Imle, Andrea ; Fellermeier-Kopf, Sina ; Garrido Castro, Patricia ; Thalhauser, Craig J

Background:

Next-generation cancer immunotherapies aim to improve patient outcomes by combining inhibitory signal blockade with targeted T-cell costimulation in tumor and lymphoid tissues. Acasunlimab (DuoBody-PD-L1×4-1BB) is an investigational, bispecific antibody designed to elicit an antitumor immune response via conditional 4-1BB activation strictly dependent on simultaneous programmed death-ligand 1 (PD-L1) binding. Since 4-1BB is coexpressed with programmed cell death protein-1 (PD-1) on CD8+T cells, PD-1 blockade and simultaneous costimulation through 4-1BB may synergistically enhance T-cell effector functions. We hypothesized that combining acasunlimab with PD-1 blockade to fully disrupt PD-1 interactions with both PD-L1 and PD-L2 would amplify the depth and duration of antitumor immunity.

Methods:

The effect of acasunlimab and pembrolizumab combination was analyzed in vitro using functional immune cell assays, including mixed-lymphocyte reactions and antigen-specific T-cell proliferation and cytotoxicity assays. The antitumor activity of the combination was tested in vivo in (1) MC38, MB49, Pan02, and B16F10 syngeneic tumor models using acasunlimab and anti-PD-1 mouse-surrogate antibodies; and (2) triple knock-in mice expressing the human targets using an acasunlimab chimeric antibody (chi-acasunlimab) and pembrolizumab. The mechanism of action of the combination was investigated in the MC38 syngeneic model through immunohistochemistry, flow cytometry, and bulk RNA sequencing.

Results:

The combination reinvigorated dysfunctional T cells in vitro, while also potentiating T-cell expansion, interleukin (IL)-2 and interferon gamma secretion and cytotoxic activity. In vivo, the combination of chi-acasunlimab and pembrolizumab or mouse-surrogate antibodies potentiated antitumor activity and survival in the humanized knock-in and multiple syngeneic mouse models, leading to durable complete tumor regressions in the MC38 model consistent with therapeutic synergy. Mechanistically, the combination enhanced clonal expansion of tumor-specific CD8+T cells in tumor-draining lymph nodes and increased the density of proliferating and cytotoxic CD8+T cells in the tumor microenvironment. It also potentiated the IL-2 signaling pathway, increasing the proportion of granzyme B (GZMB+) stem-like CD8+T cells thought to have superior effector function.

Conclusion:

These preclinical results demonstrate that conditional 4-1BB stimulation combined with complete PD-1 blockade enhances antitumor immunity through complementary mechanisms. The acasunlimab and pembrolizumab combination is being evaluated in Phase 2 (NCT05117242) and pivotal Phase 3 (NCT06635824) trials in patients with metastatic non-small cell lung cancer after checkpoint inhibitor therapy failure.

02 May 2022·Cancer discovery

Preclinical Characterization and Phase I Trial Results of a Bispecific Antibody Targeting PD-L1 and 4-1BB (GEN1046) in Patients with Advanced Refractory Solid Tumors

Article

Author: Burm, Saskia M. ; Muik, Alexander ; Türeci, Özlem ; LoRusso, Patricia M. ; Ahmadi, Tahamtan ; Verzijl, Dennis ; Vascotto, Fulvia ; Garralda, Elena ; Stanganello, Eliana ; van den Brink, Edward N. ; Geva, Ravit ; Breij, Esther C.W. ; Lagkadinou, Eleni ; Quinkhardt, Juliane ; Ben-Ami, Eytan ; Forssmann, Ulf ; Kreiter, Sebastian ; Bajaj, Gaurav ; Fereshteh, Mark ; Şahin, Uğur ; Rodriguez-Ruiz, Maria E. ; Salcedo, Theodora W. ; Plantinga, Theo S. ; Schoedel, Kristina B. ; Diken, Mustafa ; Maurice-Dror, Corinne ; Altintas, Isil ; Satijn, David ; Calvo, Emiliano ; Sänger, Bianca ; Sette, Angelica ; Gieseke, Friederike ; Blum, Jordan M. ; Alonso, Guzman ; Sasser, Kate ; Toker, Aras ; Melero, Ignacio ; Jure-Kunkel, Maria

Abstract:

Checkpoint inhibitors (CPI) have revolutionized the treatment paradigm for advanced solid tumors; however, there remains an opportunity to improve response rates and outcomes. In preclinical models, 4-1BB costimulation synergizes with CPIs targeting the programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) axis by activating cytotoxic T-cell–mediated antitumor immunity. DuoBody-PD-L1×4-1BB (GEN1046) is an investigational, first-in-class bispecific immunotherapy agent designed to act on both pathways by combining simultaneous and complementary PD-L1 blockade and conditional 4-1BB stimulation in one molecule. GEN1046 induced T-cell proliferation, cytokine production, and antigen-specific T-cell–mediated cytotoxicity superior to clinically approved PD-(L)1 antibodies in human T-cell cultures and exerted potent antitumor activity in transplantable mouse tumor models. In dose escalation of the ongoing first-in-human study in heavily pretreated patients with advanced refractory solid tumors (NCT03917381), GEN1046 demonstrated pharmacodynamic immune effects in peripheral blood consistent with its mechanism of action, manageable safety, and early clinical activity [disease control rate: 65.6% (40/61)], including patients resistant to prior PD-(L)1 immunotherapy.

Significance::

DuoBody-PD-L1×4-1BB (GEN1046) is a first-in-class bispecific immunotherapy with a manageable safety profile and encouraging preclinical and early clinical activity. With its ability to confer clinical benefit in tumors typically less sensitive to CPIs, GEN1046 may fill a clinical gap in CPI-relapsed or refractory disease or as a combination therapy with CPIs.See related commentary by Li et al., p. 1184.This article is highlighted in the In This Issue feature, p. 1171

News (Medical) associated with Acasunlimab

10 Mar 2025

·www.fiercebiotech.com

J&J opts out of licensing Genmab\'s Darzalex challenger after look at phase 1/2 data

Among 84 patients evenly split in each study arm, HexaBody-CD38 elicited an objective response rate of 55% compared to 52% in the Darzalex arm.\n Johnson & Johnson is dropping a partnership with Genmab centered around a CD38 monoclonal antibody, prompting the latter company to discontinue development of the program.Back in 2019, the companies teamed up to develop a successor to their multiple myeloma blockbuster Darzalex, an anti-CD38 antibody. The deal gave J&J the option to license HexaBody-CD38—which was designed using Genmab tech that aims to dial up the cancer-killing power of therapeutics—after a proof-of-concept study for $150 million, plus potential milestones and royalties. Now, the Big Pharma has determined that it won’t exercise that option, according to a March 10 release. Furthermore, Genmab has decided that it won’t continue development of the monoclonal antibody.Genmab credited the discontinuation to a “thorough evaluation of the data, the market landscape and Genmab’s rigorous portfolio prioritization.”In 2020, Sanofi\'s Sarclisa (isatuximab-irfc), a CD38-directed cytolytic antibody, snared FDA approval to treat patients with relapsed or refractory multiple myeloma. Since then, the FDA has also granted the immunotherapy approval for newly treated myeloma. Under the terms of Genmab\'s agreement with J&J, the Danish company provided data from a clinical proof-of-concept study in multiple myeloma, including a head-to-head comparison with Darzalex (daratumumab).The phase 2 expansion part of the trial assessed the objective response rate (ORR) of intravenous HexaBody-CD38 versus subcutaneous daratumumab in patients with anti-CD38 antibody-naïve relapsed or refractory multiple myeloma.Among 84 patients evenly split in each arm, HexaBody-CD38 elicited an ORR of 55% compared to 52% in the daratumumab arm.The complete response rate was 7% for HexaBody-CD38 and 2% for daratumumab.Duration of response, progression-free survival and overall survival were not yet reached at the time of data cutoff. Genmab expects to share more mature data at a future medical conference. Treatment-emergent adverse events affecting more than 20% of patients in the HexaBody-CD38 arm were neutropenia, infusion-related reactions, anemia and thrombocytopenia. One patient died from a TEAE in the HexaBody-CD38 arm, while two patients died in the daratumumab arm; the three deaths were not related to the study treatment, according to Genmab. “While we are disappointed that J&J has decided not to advance HexaBody-CD38, the data confirms the clinical potential of the HexaBody platform, reinforcing its value for future applications,” Genmab CEO Jan van de Winkel, Ph.D., said in the release.The leader instead pointed to later-stage opportunities in Genmab’s pipeline, such as rinatabart sesutecan (Rina-S)—a potential challenger to AbbVie’s Elahere that Genmab gained in its $1.8 billion ProfoundBio buyout—and PD-L1x4-1BB bispecific antibody acasunlimab. Both assets are currently undergoing phase 3 testing. The pipeline discontinuation and J&J’s decision not to take up the option for HexaBody-CD38 do not impact Genmab’s 2025 financial guidance, according to the company. Analysts at William Blair called the opt-out \"unfortunate but largely expected\" in a March 10 note, adding that \"getting past the highly anticipated JNJ decision and expected share pullback now allows investors to focus on the company’s pipeline and potential blockbusters including Epkinly, Rina-S and acasunlimab.\"Since the company’s announcement, which was made around 10 a.m. ET, Genmab’s stock has dropped more than 8% from its market open price of $23.93 per share, settling at $21.98 as of 4 p.m. ET on March 10.Editor\'s note: This story was updated at 5:30 p.m. ET on March 10 to include analysis from William Blair.

License out/inPhase 2ImmunotherapyClinical ResultDrug Approval

10 Mar 2025

·pipelinereview.com

Genmab Announces Johnson & Johnson Decision Regarding HexaBody®-CD38

COPENHAGEN, Denmark I March 10, 2025 I Genmab A/S (Nasdaq: GMAB) announced today that Johnson & Johnson (J&J) has decided that it will not exercise its option to receive a worldwide license to develop, manufacture and commercialize HexaBody-CD38 (GEN3014). While the initial HexaBody-CD38 clinical data is promising and showed robust clinical efficacy, following a thorough evaluation of the data, the market landscape, and Genmab’s rigorous portfolio prioritization, Genmab will not pursue further clinical development of HexaBody-CD38. “While we are disappointed that J&J has decided not to advance HexaBody-CD38, the data confirms the clinical potential of the HexaBody platform, reinforcing its value for future applications,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “With EPKINLY ® (epcoritamab) moving from strength to strength and two wholly owned assets, rinatabart sesutecan (Rina-S™) and acasunlimab in Phase 3 development, we are confident in the potential of our existing pipeline of innovative antibody therapeutics. Genmab intends to maintain its laser sharp focus on and disciplined investments in our promising late-stage proprietary clinical pipeline and continues to execute against our capital allocation framework ensuring future growth.” As stipulated by the development and option agreement between Genmab and J&J for HexaBody-CD38, Genmab provided J&J with data from a clinical proof-of-concept study in multiple myeloma, including a head-to-head comparison with DARZALEX FASPRO ® (daratumumab and hyaluronidase fihj). The Phase 2 expansion Part B of the study assessed the objective response rate (primary endpoint) of intravenous HexaBody-CD38 versus subcutaneous daratumumab in patients with anti-CD38 antibody- naïve relapsed or refractory multiple myeloma. Preliminary data submitted by Genmab to J&J, inclusive of 88 patients who received a study treatment and 84 patients who were response evaluable (42 in each arm), demonstrated an overall response rate (ORR) of 55% (95% CI: 39%, 70%) in the HexaBoby-CD38 IV arm vs. 52% in the daratumumab SC arm (95% CI: 36%, 68%); very good partial response (VGPR) or better rate was 29% vs. 17%; and complete response (CR) or better rate was 7% vs. 2%. Due to the relatively short follow-up time, secondary efficacy endpoints including duration of response, progression-free survival, and overall survival were not mature yet. Treatment emergent Adverse events (TEAEs) above 20% in the Hexabody-CD38 arm were neutropenia, infusion related reactions, anemia, and thrombocytopenia. No new safety findings were observed in the daratumumab arm of the study. TEAEs leading to death included one patient in the HexaBody-CD38 IV arm and two patients in the daratumumab SC arm; none of these deaths was related to the study treatment. Follow-up is ongoing and more mature data will be presented at a future medical conference. This news does not impact Genmab’s 2025 Financial Guidance. Conference Call Details Genmab will host a conference call to discuss this event today at 5:00 PM CET / 4:00 PM GMT / 12:00 PM EDT. To join the call or listen to the webcast, please register using the following link: https://genmab-investor-update-mar2025.open-exchange.net/ . An archived webcast of the call will be available at https://www.genmab.com/investor-relations . About the 3014-01 Trial 3014-01 is a Phase 1/2, open-label, multi-center trial to evaluate the safety and preliminary efficacy of HexaBody-CD38 as a monotherapy in patients with relapsed or refractory multiple myeloma and other blood cancers. The trial consists of three parts: a dose-escalation phase (Phase 1) and an expansion phase (Part A and Part B). The primary objective of Phase 1 is to determine the recommended Phase 2 dose and the maximum tolerated dose as well as establish the safety profile of HexaBody-CD38 monotherapy. The purpose of Phase 2 Expansion Part A is to assess the objective response rate of HexaBody-CD38 for patients with relapsed or refractory multiple myeloma and other blood cancers. The purpose of Phase 2 Expansion Part B is to assess the objective response rate of HexaBody-CD38 versus subcutaneous daratumumab in patients with CD38 antibody naïve relapsed or refractory multiple myeloma. More information on this trial can be found at https://www.clinicaltrials.gov (NCT04824794). About Genmab Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For more than 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO) antibody medicines ® . Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X . SOURCE: Genmab

Clinical ResultPhase 2License out/inImmunotherapyPhase 3

10 Mar 2025

·www.businesswire.com

Genmab Announces Johnson & Johnson Decision Regarding HexaBody -CD38

COPENHAGEN, Denmark--(BUSINESS WIRE)--Genmab A/S (Nasdaq: GMAB) announced today that Johnson & Johnson (J&J) has decided that it will not exercise its option to receive a worldwide license to develop, manufacture and commercialize HexaBody-CD38 (GEN3014). While the initial HexaBody-CD38 clinical data is promising and showed robust clinical efficacy, following a thorough evaluation of the data, the market landscape, and Genmab’s rigorous portfolio prioritization, Genmab will not pursue further clinical development of HexaBody-CD38. “While we are disappointed that J&J has decided not to advance HexaBody-CD38, the data confirms the clinical potential of the HexaBody platform, reinforcing its value for future applications,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “With EPKINLY® (epcoritamab) moving from strength to strength and two wholly owned assets, rinatabart sesutecan (Rina-S™) and acasunlimab in Phase 3 development, we are confident in the potential of our existing pipeline of innovative antibody therapeutics. Genmab intends to maintain its laser sharp focus on and disciplined investments in our promising late-stage proprietary clinical pipeline and continues to execute against our capital allocation framework ensuring future growth.” As stipulated by the development and option agreement between Genmab and J&J for HexaBody-CD38, Genmab provided J&J with data from a clinical proof-of-concept study in multiple myeloma, including a head-to-head comparison with DARZALEX FASPRO® (daratumumab and hyaluronidase fihj). The Phase 2 expansion Part B of the study assessed the objective response rate (primary endpoint) of intravenous HexaBody-CD38 versus subcutaneous daratumumab in patients with anti-CD38 antibody- naïve relapsed or refractory multiple myeloma. Preliminary data submitted by Genmab to J&J, inclusive of 88 patients who received a study treatment and 84 patients who were response evaluable (42 in each arm), demonstrated an overall response rate (ORR) of 55% (95% CI: 39%, 70%) in the HexaBoby-CD38 IV arm vs. 52% in the daratumumab SC arm (95% CI: 36%, 68%); very good partial response (VGPR) or better rate was 29% vs. 17%; and complete response (CR) or better rate was 7% vs. 2%. Due to the relatively short follow-up time, secondary efficacy endpoints including duration of response, progression-free survival, and overall survival were not mature yet. Treatment emergent Adverse events (TEAEs) above 20% in the Hexabody-CD38 arm were neutropenia, infusion related reactions, anemia, and thrombocytopenia. No new safety findings were observed in the daratumumab arm of the study. TEAEs leading to death included one patient in the HexaBody-CD38 IV arm and two patients in the daratumumab SC arm; none of these deaths was related to the study treatment. Follow-up is ongoing and more mature data will be presented at a future medical conference. This news does not impact Genmab’s 2025 Financial Guidance. Conference Call Details Genmab will host a conference call to discuss this event today at 5:00 PM CET / 4:00 PM GMT / 12:00 PM EDT. To join the call or listen to the webcast, please register using the following link: https://genmab-investor-update-mar2025.open-exchange.net/. An archived webcast of the call will be available at https://www.genmab.com/investor-relations. About the 3014-01 Trial 3014-01 is a Phase 1/2, open-label, multi-center trial to evaluate the safety and preliminary efficacy of HexaBody-CD38 as a monotherapy in patients with relapsed or refractory multiple myeloma and other blood cancers. The trial consists of three parts: a dose-escalation phase (Phase 1) and an expansion phase (Part A and Part B). The primary objective of Phase 1 is to determine the recommended Phase 2 dose and the maximum tolerated dose as well as establish the safety profile of HexaBody-CD38 monotherapy. The purpose of Phase 2 Expansion Part A is to assess the objective response rate of HexaBody-CD38 for patients with relapsed or refractory multiple myeloma and other blood cancers. The purpose of Phase 2 Expansion Part B is to assess the objective response rate of HexaBody-CD38 versus subcutaneous daratumumab in patients with CD38 antibody naïve relapsed or refractory multiple myeloma. More information on this trial can be found at https://www.clinicaltrials.gov (NCT04824794). About Genmab Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For more than 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO) antibody medicines®. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X. This Company Announcement contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect® and KYSO®. DARZALEX FASPRO® is a trademark of Johnson & Johnson. EPKINLY® and its design is a trademark of AbbVie Biotechnology Ltd. Rina-S™ is a trademark of ProfoundBio, US Co. and ProfoundBio (Suzhou) Co., Ltd. Company Announcement no. 09 CVR no. 2102 3884 LEI Code 529900MTJPDPE4MHJ122 Genmab A/S Carl Jacobsens Vej 30 2500 Valby, Denmark

Clinical ResultPhase 2License out/inPhase 3

100 Deals associated with Acasunlimab

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	United States	Genmab A/S	25 Nov 2024
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	Japan	Genmab A/S	25 Nov 2024
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	Bulgaria	Genmab A/S	25 Nov 2024
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	France	Genmab A/S	25 Nov 2024
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	Netherlands	Genmab A/S	25 Nov 2024
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	Puerto Rico	Genmab A/S	25 Nov 2024
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	United Kingdom	Genmab A/S	25 Nov 2024
Melanoma, Cutaneous Malignant	Phase 2	-	Genmab A/S	30 Jun 2025
Metastatic melanoma	Phase 2	-	Genmab A/S	30 Jun 2025
Unresectable Melanoma	Phase 2	-	Genmab A/S	30 Jun 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05117242 (655, SITC2024)	Phase 2	metastatic non-small cell lung cancer PD-L1+ \| CD8 + \| s4-1BB ... View more	79	Acasunlimab 100 mg Q3Wx2 cycles, then 500 mg Q6W	bmbibnevjp(mgjqrwgqgl) = hgsuyrhseo ixojryzntp (azzzdbukyr )	Positive	05 Nov 2024
NCT05117242 (ASCO2024) Manual	Phase 2	metastatic non-small cell lung cancer Second line PD-L1 Positive	98	Acasunlimab monotherapy	cpannqiqyr(zibxokgcdd) = zbwbiclilv ponzunomer (msxygyfoto ) View more	Positive	24 May 2024
NCT05117242 (ASCO2024) Manual	Phase 2		98	Acasunlimab + pembrolizumab (200 mg)	cpannqiqyr(zibxokgcdd) = oxjgqxcccm ponzunomer (msxygyfoto ) View more	Positive	24 May 2024
NCT03917381 (GEN1046, SITC2021)	Phase 1/2	Neoplasms PD-L1+ \| 4-1BB+ \| IFN-y ... View more	40	DuoBody-PD-L1Ã—4-1BB (GEN1046)	hgtdehfssk(lcbnkfessi) = insreukslk lvpfmwmzqp (dygayqrmrt )	Positive	10 Nov 2021

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis