On October 15, 2023 Novocure (NASDAQ: NVCR) reported its participation in the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 from October 20 – 24 in Madrid (Press release, NovoCure, OCT 15, 2023, View Source [SID1234635982]). Novocure will present three new posters on Tumor Treating Fields (TTFields) therapy, including an analysis of patient-reported health-related global and functional quality of life scores from the randomized phase 3 LUNAR clinical trial in metastatic non-small cell lung cancer (NSCLC).

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The new analysis of data from LUNAR utilized The European Organization for Research and Treatment of Cancer Quality of Life questionnaire-C30. Analysis showed no statistically significant difference between patients who received TTFields therapy together with standard systemic therapies and patients who received standard systemic therapies alone in median time to deterioration for global health status (4.4 vs 4.0 months, P=0.91) and for all five functional scales: physical functioning (3.2 vs 4.2 months, P=0.58), role functioning (3.0 vs 2.8 months, P=0.59), emotional functioning (6.6 vs 5.7 months, P=0.96), cognitive functioning (3.7 vs 4.4 months, P=0.23), and social functioning (4.0 vs 3.9 months, P=0.66).

Highlights of Novocure’s presentations at the ESMO (Free ESMO Whitepaper) Congress 2023 also include global post-marketing surveillance data from patients with high-grade gliomas, confirming the well-tolerated safety profile of TTFields therapy in a subgroup of patients ages 70 and older in the real-world setting, which is consistent with data from Novocure’s EF-14 clinical trial. Another highlight is survey data from patients with glioblastoma (GBM) using TTFields therapy in the United States and DACH region (Germany, Austria and Switzerland), which showed that most patients were very satisfied or satisfied with TTFields therapy. Most said they would recommend TTFields therapy to a friend or acquaintance with GBM.

Novocure will also host an industry-sponsored symposium, titled The Evolving Role of TTFields Therapy in Solid Tumors, in Oviedo Auditorium, Hall 7, on Oct. 23 at 1 p.m. CEST.

"We are encouraged by new data supporting the use of TTFields therapy in the management of metastatic NSCLC and further validating the favorable safety and patient satisfaction profiles of TTFields therapy in patients with aggressive central nervous system tumors," said Pritesh Shah, Novocure’s Chief Growth Officer. "We look forward to sharing these insights with, and continuing to learn from, leading medical oncologists in Europe and worldwide."

Novocure’s full list of presentations at the ESMO (Free ESMO Whitepaper) Congress 2023 includes:

Post-marketing surveillance data from patients ≥70 years of age with central nervous system malignancies treated with Tumor Treating Fields (TTFields) therapy between 2011–2022. Presenter: Wenyin Shi. 12 p.m. CEST on Sunday, Oct. 22.
Tumor Treating Fields therapy for glioblastoma: Identifying needs and satisfaction of new and long-term users. Presenter: Eleni Batzianouli. 12 p.m. CEST on Sunday, Oct. 22.
Impact of TTFields therapy on global and functional health-related quality of life (HRQoL) in metastatic non-small cell lung cancer (mNSCLC) from the pivotal LUNAR study. Presenter: Joachim Aerts. 12 p.m. CEST on Monday, Oct. 23.
Symptom burden and health-related quality of life (HRQoL) in platinum-resistant or -refractory ovarian cancer (PROC): a systematic literature review (SLR). Presenter: Nikhila Indukuri. 12 p.m. CEST on Saturday, Oct. 21.
About Tumor Treating Fields Therapy

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. The multiple, distinct mechanisms of TTFields therapy work together to selectively target and kill cancer cells. Due to its multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about Tumor Treating Fields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

On October 15, 2023 CatalYm reported new preclinical data expanding the mechanistic understanding of how GDF-15 plays a key role in cancer therapy resistance (Press release, Catalym, OCT 15, 2023, View Source [SID1234635981]). The results will be presented in a poster session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 in Madrid, Spain on Sunday, October 22nd by CatalYm’s CSO, Dr. Christine Schuberth-Wagner. The data are the first to show that GDF-15 has an inhibitory effect on the activation of M1 macrophages. These specific myeloid lineage immune cells are central to the initiation of immune responses, including the secretion of pro-inflammatory cytokines and chemokines, presentation of antigens as well as direct antitumor cytotoxicity.

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"The findings, therefore, provide additional support for the potential of GDF-15 neutralizing approaches as a critical component for treatment success in a broad range of anti-cancer regimens."

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The results support and expand on initial findings, recently published in Nature Communications, on pathways involved in the development of GDF-15 mediated therapy resistance in cancer cells. These data were the first to demonstrate a mechanistic link between GDF-15 and inhibition of the LFA-1/ICAM-1 cell adhesion axis in cancer, resulting in impaired infiltration of T cells into the tumor microenvironment.

"The ESMO (Free ESMO Whitepaper) data add to recently discovered mechanistic effects of GDF-15 impairing T cell infiltration into tumors and show the impairment of another important immune cell compartment by GDF-15, thereby expanding our understanding of its role in establishing tumor resistance to current cancer therapies. Interestingly, M1 macrophages are crucial for initiation of anti-tumoral immune responses and in parallel are active in tumor cell destruction by phagocytosis and oxidative stress," said Dr. Christine Schuberth-Wagner, Chief Scientific Officer at CatalYm. "The findings, therefore, provide additional support for the potential of GDF-15 neutralizing approaches as a critical component for treatment success in a broad range of anti-cancer regimens."

The preclinical data comprise in vitro analyses demonstrating that GDF-15 inhibits the polarization of M0 to M1 macrophages, indicated by a reduction of activation marker expression as well as MHC-II and Fcg-receptors. These phenotypic changes are accompanied by an altered cytokine expression and secretion profile. The activation was restored when GDF-15 was neutralized with CatalYm’s anti-GDF-15 antibody candidate, visugromab. In in vivo melanoma models, knock-out of GDF-15 led to an increase of counts and activation status of macrophages and antigen-presenting dendritic cells in tumor tissue. Overall, the results indicate that GDF-15 counteracts myeloid immune cell activation, supporting the generation of an immune-evasive tumor microenvironment, an important feature in therapy resistance.

CatalYm is investigating its GDF-15-neutralizing antibody visugromab in the GDFather (GDF-15 Antibody-mediaTed Human Effector Cell Relocation) trials in combination with the anti-PD-1 inhibitor nivolumab in patients with advanced solid tumors. Interim data from the Phase 2 (NCT04725474) trial recently presented at ASCO (Free ASCO Whitepaper) continue to demonstrate a very good safety and tolerability profile and promising durable, confirmed responses in major cancer indications, including non-small cell lung cancer (NSCLC), bladder cancer and hepatocellular carcinoma (HCC). The company expects to report mature data readouts for efficacy and safety from the core Phase 2a program as well as main biomarker-correlations before the end of 2023.

About Visugromab (CTL-002)

Visugromab is a monoclonal antibody that neutralizes the tumor-derived Growth Differentiation Factor-15 (GDF-15), a locally acting immunosuppressant fostering immunotherapy resistance. Neutralizing GDF-15 with visugromab reverses key cancer resistance mechanisms to reinstate an efficient anti-tumor response by reenabling immune cell activation and tumor infiltration. Visugromab has already demonstrated a good safety profile and potent and durable anti-tumor efficacy in combination with anti-PD-1 treatment in advanced cancer patients The antibody is currently being investigated in ongoing Phase 2 studies in multiple solid tumor indications.

On October 15, 2023 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, reported that it has entered into a clinical collaboration with AstraZeneca Investment (China) Co., Ltd. (or "AstraZeneca") (Press release, Ascentage Pharma, OCT 15, 2023, View Source [SID1234635979]). The two companies will jointly conduct a registrational Phase III study of the Bcl-2 inhibitor, APG-2575 (lisaftoclax), in combination with AstraZeneca’s Bruton’s tyrosine kinase (BTK) inhibitor, CALQUENCE (acalabrutinib), in treatment-naive patients with first-line chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

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This global multi-center, randomized-controlled, open-label, pivotal Phase III confirmatory trial is designed evaluate the efficacy and safety of lisaftoclax combined with acalabrutinib versus immunochemotherapy in patients with treatment-naïve CLL/SLL.

This collaboration marks another step-forward in the joint clinical development of the lisaftoclax plus acalabrutinib combination by Ascentage Pharma and AstraZeneca. In June 2020, Ascentage Pharma entered into a clinical collaboration with Acerta Pharma, a research and development center of the AstraZeneca Group, to jointly conduct a global Phase II study designed to assess the safety, tolerability, and efficacy of lisaftoclax, Ascentage Pharma’s investigational Bcl-2 selective inhibitor, in combination with acalabrutinib, Acerta Pharma’s BTK inhibitor. In the study, lisaftoclax combined with acalabrutinib showed strong therapeutic potential, with an objective response rate (ORR) of 98% in patients with relapsed/refractory (R/R) CLL/SLL, an ORR of 100% in treatment-naïve patients with CLL/SLL, and an excellent safety profile that is on par with that of lisaftoclax monotherapy[1]. Those results were released as an Oral Presentation at the 2022 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

CLL/SLL is a hematologic malignancy caused by mature B-cell neoplasms. Primarily affecting older populations, CLL/SLL is among the most common leukemia subtypes in adults and accounts for a quarter of all leukemia cases in the Western World, with over 100,000 new diagnoses reported globally each year[2]. In China, CLL/SLL is occurring at a rapidly rising incidence rate, with a younger age of onset and higher aggressiveness[3], thus posing a serious threat to public health in the country. Advancements in basic research and targeted therapies have brought meaningful survival benefit to patients with CLL/SLL. However, CLL/SLL still presents major clinical challenges and urgent medical needs for new treatment options that can offer both efficacy and safety.

Lisaftoclax is a novel, orally administered small-molecule Bcl-2 selective inhibitor being developed by Ascentage Pharma to treat malignancies by selectively blocking the antiapoptotic protein Bcl-2 and hence restoring the normal apoptosis process in cancer cells. With strong global best-in-class potential, lisaftoclax is the first Bcl-2 inhibitor in China and the second anywhere globally that has demonstrated compelling clinical activity and entered a pivotal registrational study. At present, lisaftoclax is being evaluated in multiple clinical studies across the world and more than 300 patients with CLL/SLL have already been treated with the drug. Interim results suggest that lisaftoclax, both as a monotherapy and in combination regimens, offers potent efficacy in patients with CLL/SLL and has the potential as a safer, more efficacious and more patient-friendly treatment option. It is also worth noting that in August 2023, lisaftoclax was cleared by the US Food and Drug Administration (FDA) to enter a global registrational Phase III study designed to assess the efficacy and safety of lisaftoclax combined with a BTK inhibitor in patients with CLL/SLL who have received prior therapies.

Acalabrutinib, a new generation highly selective BTK inhibitor that can specifically inhibit the BTK pathway, is a globally-adopted standard of care treatment for patients with CLL. In 2017, acalabrutinib was approved through the Priority Review process by the US Food and Drug Administration (FDA) for the second-line treatment of patients with mantle cell lymphoma (MCL), and subsequently in 2019, the drug was approved for the additional indication of adult patients with CLL/SLL. Meanwhile, acalabrutinib has been approved in more than 50 countries/regions, such as European Union and Japan until now. In China this year, acalabrutinib was sequentially approved for two indications that include patients with MCL who have received at least one prior therapy; and adult patients with CLL/SLL who have received at least one prior therapy.

Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said, "Combining Bcl-2 inhibitors and BTK inhibitors as a therapeutic approach has long attracted interest from both the research community and the industry. The Bcl-2 inhibitor lisaftoclax is a key drug candidate in Ascentage Pharma’s apoptosis-targeted pipeline. Results from the global Phase II study of lisaftoclax combined with acalabrutinib show that the combination regimen holds the promise as a patient-centric treatment strategy with enormous therapeutic potential. The clinical management of CLL/SLL overseas has already entered an era that is free of chemotherapies, and patients in China also desperately need a safer and more effective Bcl-2 inhibitor that can be combined with BTK inhibitors. Fulfilling our mission of addressing unmet clinical needs in China and around the world, we will work closely with AstraZeneca to actively advance this clinical development program of lisaftoclax and try to bring the drug to market as soon as possible for the benefit of more patients."

Ms. Haiying Yang, Vice President and Head of Medical Affairs at AstraZeneca China, commented, "Phase III results from the ASCENT, ELEVATE-TN, and ELEVATE-RR trials have solidified AstraZeneca’s position in the hematology field, while acalabrutinib-based combination regimens have been widely adopted as standard of care treatments. BTK inhibitors offer survival benefits to patients with lymphoma. However, there remains substantial clinical challenges in this therapeutic area and patients are in desperate need for new therapies that are both safe and efficacious, particularly fixed duration therapies. We are confident that acalabrutinib-based combinations can bring more effective and precision-targeting therapies to patients with hematologic malignancies in China as we take further steps in rendering hematologic malignancies into manageable chronic conditions. Through these innovative partnerships with local Chinese companies, we aspire to expand to more therapeutic areas and bring clinical benefit to a broader population of cancer patients in China."

On October 15, 2023 Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported that it will host a conference call to discuss a business update on Monday, October 16, 2023 at 7:30 a.m. ET (Press release, Merus, OCT 15, 2023, View Source [SID1234635976]).

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Zenocutuzumab (Zeno or MCLA-128: HER2 x HER3 Biclonics): NRG1 fusion (NRG1+) cancer and other solid tumors

Today two abstracts were published on the European Society for Medical Oncology Congress (ESMO) (Free ESMO Whitepaper) 2023 website. The abstracts highlight updated interim clinical data from the ongoing phase 1/2 eNRGy trial and Early Access Program (EAP) of the bispecific antibody zenocutuzumab (Zeno) in patients with neuregulin 1 fusion (NRG1+) cancer. The Principal Investigator of the eNRGy trial, Dr. Alison Schram of Memorial Sloan-Kettering Cancer Center will present a mini oral session on NRG1+ NSCLC. The ESMO (Free ESMO Whitepaper) Congress 2023 will take place in Madrid, Spain October 20-24, 2023.

"Zeno continues to show remarkably consistent efficacy over time, with robust and durable responses in these difficult-to-treat indications," said Dr. Andrew Joe, Chief Medical Officer at Merus. "We recently met with the FDA in the context of our two breakthrough therapy designations and based on these productive and collaborative discussions, we believe we will have sufficient data for both NRG1+ NSCLC and NRG1+ PDAC in the first half of 2024 to support biologics license application submissions."

Interim data included in the abstracts are from the phase 1/2 eNRGy trial and EAP which are assessing the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancer. Updated data will be provided in the presentations to include additional patients as well as follow-up on safety and efficacy for the patients presented in the abstracts:

Mini Oral Presentation Title: Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive (NRG1+) non-small cell lung cancer (NSCLC)

Observations in the abstract include:
As of a February 1, 2023 data cutoff date, 85 patients (pts) with NRG1+ NSCLC were enrolled. 64 pts with measurable disease were treated as of August 1, 2022 allowing for the potential for ≥ 6 months follow up and were evaluable for response
34% overall response rate (ORR) (95% CI, 23-47) by RECIST v1.1. per investigator assessment
78% of pts had target lesion reduction
12.9 months median duration of response (DOR), with responses ongoing in 50% of pts
Among the 85 pts enrolled, Grade ≥ 3 adverse events (AEs) irrespective of causality occurred in < 4% pts
Presentation Details:
Session Category: Mini oral session 1
Session: NSCLC, metastatic
Date: Saturday, October 21, 2023
Time: 9:35-9:40 CEST
Presentation #: 1315MO

Poster Presentation Title: Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive (NRG1+) pancreatic ductal adenocarcinoma (PDAC)

Observations in the abstract include:
As of a February 1, 2023 data cutoff date, 38 pts with NRG1+ PDAC were enrolled. 27 pts with measurable disease were treated as of August 1, 2022 allowing for the potential for ≥ 6 months follow-up and were evaluable for response
44% ORR (95% CI, 26-65) by RECIST v1.1. per investigator assessment; including 1 complete response
81% of pts had target lesion reduction and 84% of pts had CA 19-9 decline of ≥ 50% from baseline
9.1 months median DOR, with responses ongoing in 33% of pts
Among the 38 pts enrolled, Grade ≥ 3 AEs irrespective of causality occurred in < 5% pts
Presentation Details:
Session: Poster Session
Date: Monday, October 23, 2023
Time: 9:00-17:00 CEST
Presentation #: 1618P

As full presentations become available at the ESMO (Free ESMO Whitepaper) Congress 2023, they will contemporaneously be available on the Merus website.

Merus is also evaluating Zeno in combination with androgen deprivation therapy (enzalutamide or abiraterone) in men with castration resistant prostate cancer, irrespective of NRG1+ status. Merus plans to provide initial clinical data in the second half of 2023.

Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics): Solid Tumors

Merus plans to initiate the phase 3 clinical trial in mid-2024 to evaluate petosemtamab monotherapy in previously treated recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Earlier this year in a presentation at the American Association of Cancer Research Annual Meeting, interim clinical data in this indication, having a data cutoff date of February 1, 2023, demonstrated the high and durable efficacy of petosemtamab with a well-tolerated and manageable safety profile.

"We’re very excited to start enrolling the randomized phase 3 trial as we believe we have an opportunity to significantly improve the outcomes of patients with head and neck cancer," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "Additionally, we are encouraged to report that among the initial patients dosed in the front-line combination of petosemtamab with Keytruda, the safety profile has been observed to be generally favorable with no dose limiting toxicities reported to date."

In the planned phase 3 trial, patients will be randomized to petosemtamab monotherapy or to investigators choice of single agent chemotherapy or cetuximab. Data regarding the INTERLINK-1 trial was released today ahead of the ESMO (Free ESMO Whitepaper) Congress 2023. Merus believes the clinical activity of cetuximab monotherapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck who received prior platinum-based chemotherapy and a PD-1/PD-L1 inhibitor, further supports the planned design of our phase 3 clinical trial.

Merus continues to enroll approximately 40 patients with previously treated HNSCC with petosemtamab monotherapy at the 1100 or 1500 mg dose levels to confirm a suitable dose for future potential randomized trials. Merus plans to share the clinical data from this cohort in 2024.

Merus also continues to enroll patients with previously untreated advanced PD-L1+ HNSCC with petosemtamab 1500 mg in combination with Keytruda. Initial safety data from this single arm cohort may support the initiation of a first-line registration trial with this combination. Merus plans to report initial interim safety and efficacy data from this cohort in the first half of 2024.

MCLA-129 (EGFR x c-MET Biclonics): Solid Tumors

Abstracts on the bispecific antibody MCLA-129 in NSCLC and in previously treated HNSCC were selected for presentation at the ESMO (Free ESMO Whitepaper) Asia Congress 2023 taking place in Singapore December 1-3, 2023.

Title: Efficacy and safety of MCLA-129, an EGFR x c-MET bispecific antibody, combined with osimertinib, as first-line therapy or after progression on osimertinib in non-small cell lung cancer (NSCLC)

Title: Efficacy and safety of MCLA-129, an anti-EGFR/c-MET bispecific antibody, in head and neck squamous cell cancer (HNSCC)

Merus is discontinuing the NSCLC with EGFR exon20 mutation cohort due to the competition in this niche market.

Company Conference Call and Webcast Information

Merus will hold a conference call and webcast for investors on October 16, 2023 at 7:30 a.m. ET. A replay will be available after the completion of the call in the Investors and Media section of our website for a limited time.

Date and Time: October 16, 2023 at 7:30 a.m. ET
Webcast link: Available on our website
Dial-in: Toll-Free: 1 (800) 715-9871 / International: 1 (646) 307-1963
Conference ID: 6064075

On October 15, 2023 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported the latest clinical data in early- and late-stage cancers from its oncology pipeline will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 from October 20 to 24 in Madrid, Spain (Press release, Regeneron, OCT 15, 2023, View Source [SID1234635972]). The presentations demonstrate the role of Libtayo (cemiplimab) as both a monotherapy and a backbone of novel investigational combinations for various solid tumors.

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"Our data presentations at ESMO (Free ESMO Whitepaper) underscore Regeneron’s ability to apply a deep understanding of cancer biology, genetics and the immune system to advance the development of meaningful combinations for cancer types that have high unmet need," said Israel Lowy, Senior Vice President, Translational and Clinical Oncology at Regeneron. "Notably, we are presenting the first survival data for neoadjuvant Libtayo therapy in cutaneous squamous cell carcinoma and the first results for Libtayo in combination with ubamatamab, our investigational MUC16xCD3 bispecific antibody, in recurrent ovarian cancer. Beyond ESMO (Free ESMO Whitepaper), we are excited by recent progress across our oncology portfolio, including FDA Fast Track Designation for fianlimab (LAG-3) plus Libtayo in melanoma. We look forward to sharing more with the global oncology community as we deliver on our promise to improve the lives of those impacted by cancer."

Among Regeneron’s ESMO (Free ESMO Whitepaper) presentations is an oral highlighting one-year survival outcomes, including event-free survival, from a Phase 2 trial of Libtayo in neoadjuvant CSCC. The primary analysis was shared at last year’s ESMO (Free ESMO Whitepaper) meeting.

Regeneron will also debut Phase 1 dose-escalation results for its investigational combination of Libtayo and ubamatamab in patients with heavily pretreated recurrent ovarian cancer in a poster session. A Phase 2 expansion portion of the study is underway. Ubamatamab is a CD3-targeting bispecific designed to bridge MUC16 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation.

Additional presentations at ESMO (Free ESMO Whitepaper) include subgroup analyses of Libtayo in advanced non-small cell lung cancer (NSCLC), focusing on such populations as squamous cell carcinoma and patients with varying levels of PD-L1 expression.

Regeneron presentations at ESMO (Free ESMO Whitepaper):

Medicine Abstract title Abstract Lead Author Presentation date/time
(all CEST)
Skin cancer
Libtayo A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV Cutaneous Squamous Cell Carcinoma (CSCC): One-year Follow-up #1088MO

Neil D. Gross, M.D., F.A.C.S. Saturday, October 21, 2023; 14:45 – 16:15
Libtayo Cemiplimab Versus Historical Systemic Treatments for Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinomas: Results From the French Study TOSCA #1140P Emilie Gerard, M.D. Sunday, October 22, 2023; 09:00 – 17:00
Ovarian cancer
Ubamatamab, Libtayo Ubamatamab (MUC16xCD3 Bispecific Antibody) with Cemiplimab (Anti-PD-1 Antibody) in Recurrent Ovarian Cancer: Phase 1 Dose-Escalation Study #754P

Roisin E O’Cearbhaill, M.D. Sunday, October 22, 2023; 09:00 – 17:00
Lung cancer
Libtayo, chemotherapy Patient-reported Outcomes (PROs) with Cemiplimab Plus Chemotherapy (CEMI + CHEMO) for First-line Treatment of Advanced Non-small Cell Lung Cancer (aNSCLC): PD-L1 Level Subgroups in EMPOWER-Lung 3 #1443P

Miranda Gogishvili, M.D. Monday, October 23, 2023; 09:00 –17:00
Libtayo, chemotherapy Cemiplimab Plus Chemotherapy Versus Chemotherapy in Non-small Cell Lung Cancer with PD-L1 ≥1%: EMPOWER-Lung 3 Results #1495P

Ana Baramidze, M.D., Ph.D. Monday, October 23, 2023; 09:00 –17:00
Libtayo Cemiplimab for Advanced Non-small Cell Lung Cancer: Squamous Subgroup Analysis for EMPOWER-Lung 1 and 3 #1438P

Tanta Makharadze, M.D. Monday, October 23, 2023; 09:00 –17:00
Libtayo, BNT116 A Phase 2 Study of Cemiplimab Plus BNT116 Versus Cemiplimab Alone in First-line Treatment of Patients with Advanced Non-small Cell Lung Cancer with PD-L1 Expression ≥50% #1503TiP

Mark Awad, M.D., Ph.D. Monday, October 23, 2023; 09:00 –17:00

The potential uses of Libtayo for neoadjuvant CSCC as well as the combinations of ubamatamab and Libtayo, and BNT116 and Libtayo described above are investigational, and their safety and efficacy have not been fully evaluated by any regulatory authority.