On October 12, 2023 mAbxience (a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma) has reported an exclusive licensing agreement with Amneal Pharmaceuticals, Inc. (NYSE: AMRX), an integrated specialty pharmaceutical company powered by a robust U.S. generics business, to commercialize two denosumab biosimilars in the U.S. market (Press release, mAbxience, OCT 12, 2023, View Source [SID1234635885]).

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Denosumab is a monoclonal antibody drug that inhibits bone reabsorption. It is indicated for two major categories of therapy: bone metastasis from various forms of cancer and prevention of bone pain and fractures, including osteoporosis-related injuries.

Under the terms of the agreement, mAbxience will conduct the full development of the two biosimilars candidates and manufacture them in its state-of-the-art, Good Manufacturing Practice (GMP)-approved facilities, while Amneal will guide the products through regulatory approval and have exclusive commercialization rights in the United States. The financial terms of the transaction were not disclosed.

This partnership with Amneal not only bolsters mAbxience’s footprint in the U.S. market, but also fortifies the successful collaboration with Amneal, initiated in 2018 with an exclusive agreement for bevacizumab.

"We are thrilled to strengthen our partnership with Amneal through this second agreement, marking a significant step forward in our shared mission to enhance global health. This collaboration will bring two world-class biosimilars for the treatment of bone diseases and oncology to patients across the U.S., reinforcing our commitment to ensuring worldwide access to high-quality, life-enhancing treatments. Together with Amneal, we continue to make strides in offering affordable and accessible healthcare solutions, contributing positively to public health and solidifying our presence in the global biosimilar space," said Emmanuelle Lepine, Chief Executive Officer, mAbxience.

"Our goal is to be a top five player in the U.S. biosimilar space, similar to our leadership position in U.S. retail generics. Biosimilars represent the next wave of affordable medicines and these new product opportunities are aligned with our strategy to provide high quality, essential therapies," said Harsher Singh, Senior Vice President, Amneal Biosciences. "Our first three commercial U.S. biosimilars are doing very well as our excellent commercial team drives uptake in these competitive categories. We are pleased to partner again with mAbxience on these next two biosimilar candidates, which deepens our pipeline and expands our presence in oncology."

According to IQVIA, U.S. annual sales for Prolia and XGEVA for the 12 months ended August 2023 were approximately $4.4 billion.

The American Cancer Society estimates that in 2023, there will be over 1.9 million new cancer cases diagnosed. Beyond cancer, in the United States, the incidence of bone diseases is a growing concern. In 2010, it was estimated that a staggering 10.2 million adults were diagnosed with osteoporosis, with women constituting over 80% of this demographic[1]. This alarming trend is set to continue, with projections indicating a 310% increase in hip fractures for men and a 240% rise for women by 2050[2], a grave consequence of osteoporosis. This scenario underscores the palpable urgency for effective and accessible treatments to mitigate the impact of these conditions on the lives of millions. The commitment to advancing healthcare solutions for oncology and bone diseases remains paramount, aiming to significantly reduce its incidence and provide a better quality of life for all.

On October 12, 2023 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported that two abstracts have been accepted for poster presentation on Kineta’s immuno-oncology therapies at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting to be held November 1-5, 2023, in San Diego, California and virtually (Press release, Kineta, OCT 12, 2023, View Source;utm_medium=rss&utm_campaign=kineta-announces-kva12123-and-anti-cd27-agonist-antibody-abstracts-accepted-for-poster-presentations-at-society-for-immunotherapy-of-cancer-sitc-2023 [SID1234635884]).

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Thierry Guillaudeux, Ph.D., Chief Scientific Officer of Kineta, will be presenting posters with new clinical data on KVA12123, the company’s VISTA blocking immunotherapy currently being evaluated in a Phase 1/2 clinical trial in patients with advanced solid tumors, as well as new preclinical data on Kineta’s anti-CD27 agonist antibody program.

Presentation Details:
Title: VISTA-101 – A phase 1/2 clinical trial of KVA12123, an engineered IgG1 targeting VISTA, alone and in combination with pembrolizumab in advanced solid tumors
Abstract Number: 780
Date / Time: Saturday, November 4 at 9:00 A.M. – 7:00 P.M. Pacific Time
Location: Exhibit Halls A and B1 – San Diego Convention Center

Title: CD27 is a new promising T cell co-stimulatory target for the cancer immunotherapy – Development and selection of a lead anti-CD27 agonist antibody
Abstract Number: 1357
Date / Time: Friday, November 3 at 9:00 A.M. – 7:00 P.M. Pacific Time
Location: Exhibit Halls A and B1 – San Diego Convention Center

Abstract titles are now available on the SITC (Free SITC Whitepaper) website. Posters will be made available on the Kineta website following presentations at the conference.

On October 12, 2023 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, reported the completion of enrollment in the Phase 1 study of INB-100 in leukemia patients and the initiation of patient enrollment in the Phase 2 clinical trial evaluating INB-400 in newly diagnosed glioblastoma multiforme (GBM) (Press release, In8bio, OCT 12, 2023, View Source [SID1234635883]).

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"These important enrollment milestones reflect our continued pursuit to achieve Cancer Zero by leveraging the power of the immune system to develop therapies to eradicate cancer," said William Ho, Co-founder and CEO. "Our novel, synergistic immunotherapy approach has demonstrated promising early clinical results in patients with unmet medical needs. We look forward to progressing the INB-400 and INB-100 trials to explore the full potential of gamma-delta T cells as a treatment option for patients with both solid and hematological cancers."

Phase 1 Clinical Trial of INB-100 in Leukemia

Enrollment in the dose escalation phase of the Phase 1 clinical trial (NCT03533816) of INB-100 is now closed. This clinical trial assesses the safety of allogeneic gamma-delta T cells from haploidentical related donors that have been expanded and activated ex vivo and administered systemically to patients with leukemia following hematopoietic stem cell transplantation (HSCT). The primary endpoints of this trial are safety and tolerability, and secondary endpoints include rates of graft versus host disease (GvHD), relapse rate and OS.

In April 2023, the Company presented data at the 49th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) showing that 100% of evaluable patients (n=7) treated with INB-100 remained alive, progression-free, and in durable complete remission (CR). As of April 21, 2023, all evaluable patients across Dose Levels 1 and 2 remained on study and in CR, with one patient remaining progression free for over 3 years. Additional treated patients have remained progression free for 33.9, 22.2, 7.8, 5.8, 5.6 and 2.6 months, respectively. A clinical update with additional enrolled patients will be presented at the 65th ASH (Free ASH Whitepaper) Annual Meeting being held December 9-12, 2023 in San Diego, CA.

Phase 2 Clinical Trial of INB-400 in GBM

The Phase 2 clinical trial of INB-400 (NCT05664243), an autologous, genetically engineered gamma-delta T cell therapy, is open for enrollment and plans to enroll approximately 40 patients in "Arm A" of the study. The primary endpoint of the study is 12-month overall survival (OS) rate, and key secondary endpoints include tolerability, progression-free survival (PFS), overall response rate (ORR) and time to progression (TTP). The University of Louisville and The Cleveland Clinic are the first clinical sites activated to enroll patients.

INB-400 was granted Orphan Drug Designation by the FDA in April 2023, marking the first genetically modified gamma-delta T cell therapy to receive this regulatory designation. GBM remains a significant unmet need, treatment options and associated outcomes for GBM, a highly aggressive and difficult-to-treat brain cancer, have remained largely unchanged for more than 18 years, with a median progression-free survival of 6-7 months and overall survival of 14-16 months.

About INB-400
INB-400 is IN8bio’s DeltEx chemotherapy resistant autologous and allogeneic drug-resistant immunotherapy (DRI) technology. Allogeneic INB-400 will expand the application of DRI gamma-delta T cells into other solid tumor types through the development of allogeneic or "off-the-shelf" DeltEx DRI technology.

About INB-100
INB-100, IN8bio’s DeltEx Allo, is an allogeneic product candidate, initially developed for the treatment of patients with hematologic malignancies undergoing hematopoietic bone marrow transplantation (HSCT). It is currently being evaluated in a Phase 1 dose escalation clinical trial, marking the first clinical trial of an expanded and activated allogeneic gamma-delta T cell immunotherapy.

On October 12, 2023 Cyteir Therapeutics, Inc. ("Cyteir") (Nasdaq: CYT) reported ongoing results from a dose expansion cohort in its Phase 1 combination study of CYT-0851 with capecitabine in patients with platinum-refractory or -resistant ovarian cancer in a late-breaker poster titled "Phase 1 Dose Expansion Results of CYT-0851, a Monocarboxylate Transporter (MCT) Inhibitor, in Combination with Capecitabine in Platinum-Resistant Ovarian Cancer" (Poster: LB_A13) at the 2023 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) meeting in Boston, Massachusetts (Press release, Cyteir Therapeutics, OCT 12, 2023, View Source [SID1234635882]).

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"The results from the expansion cohort support the initial findings in our Phase 1 dose escalation study of CYT-0851 in combination with capecitabine in ovarian cancer," said Markus Renschler, MD, President and Chief Executive Officer of Cyteir, "confirming a high level of tumor control with an all-oral outpatient regimen that was generally well tolerated."

Phase 1 Study Objectives

The primary objective of the expansion cohort of the ongoing Phase 1 combination study is to determine in advanced platinum-resistant ovarian cancer patients the safety and tolerability of the CYT-0851 plus capecitabine combination. Other secondary objectives included the determination of pharmacokinetic parameters and to characterize the preliminary anti-tumor activity. The poster presents ongoing results for eleven evaluable patients with platinum-refractory or -resistant ovarian cancer treated in this expansion cohort.

Phase 1 Study Ongoing Findings

As of the September 26, 2023 data cutoff, 11 patients with advanced ovarian cancer were treated and evaluable in the capecitabine cohort. Patients were heavily pretreated, with a median of six prior treatment regimens; four patients were platinum-refractory, and seven patients were platinum-resistant. Ten patients were treated with CYT-0851 at the recommended Phase 2 dose of 400 mg daily, and one patient was treated with CYT-0851 at 300 mg daily.

Two patients had a confirmed partial response by RECIST and one additional patient achieved an unconfirmed partial response. Seven patients had stable disease and one patient had progressive disease. The disease control rate was 91% and median progression-free survival was 170 days.

To date, CYT-0851 has exhibited a generally well tolerated safety profile with no unanticipated toxicities observed at clinically active doses. The median treatment compliance was 99%. There were no treatment discontinuations or dose reductions for treatment related adverse events. All treatment related adverse events were mild (Grade 1-2). The most common adverse events were fatigue (46%) and decreased appetite, diarrhea, nausea, palmar-plantar erythrodysesthesia syndrome and vomiting (18%).

On October 12, 2023 Bristol Myers Squibb (NYSE: BMY) reported the presentation of data from over 55 Bristol Myers Squibb-sponsored, investigator-sponsored, and collaboration studies across our oncology portfolio in more than 10 tumor types at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 to be held from October 20-24 in Madrid, Spain (Press release, Bristol-Myers Squibb, OCT 12, 2023, View Source [SID1234635881]). Data from the Phase 3 CheckMate -901 and CheckMate -77T studies have been selected for presentation in Presidential Symposium sessions.

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Data to be presented support the role of Opdivo and Opdivo-based combinations in both earlier and metastatic stages of multiple cancer types, especially in patient groups with high unmet needs. Additional data will highlight the potential of repotrectinib in patients with TKI-naïve and -pretreated NTRK-positive solid tumors, including non-small cell lung cancer (NSCLC), as well as the benefit of treatment with Opdualag, the dual immunotherapy fixed-dose combination of the PD-1 inhibitor nivolumab and the LAG-3-blocking antibody relatlimab, in advanced melanoma.

"We are eager to share research during this year’s ESMO (Free ESMO Whitepaper) Congress on our immunotherapies and targeted therapies in both metastatic disease and earlier stages of several tumor types, including bladder cancer, melanoma and lung cancer," said Samit Hirawat, M.D., executive vice president, chief medical officer, Global Drug Development, Bristol Myers Squibb. "These new data highlight our leading development program for Opdivo and Opdivo-based combinations in earlier stages of cancer, as well as our commitment to meeting the challenging treatment needs of cancer patients by both continuing to study the potential of our existing medicines as well as advancing new assets that may target cancer’s vulnerabilities more precisely."

Key data highlighting approved or investigational therapies from Bristol Myers Squibb at ESMO (Free ESMO Whitepaper) 2023 include:

First presentation of overall survival (OS) and progression-free survival (PFS) data from the Phase 3 CheckMate -901 trial of Opdivo in combination with cisplatin-based chemotherapy followed by Opdivo monotherapy in the first-line treatment of patients with unresectable or metastatic urothelial carcinoma demonstrating survival benefits over standard-of-care cisplatin-based chemotherapy. CheckMate -901 is the first Phase 3 trial with an immunotherapy-based combination to demonstrate a survival benefit compared to standard-of-care cisplatin-based chemotherapy in the first-line treatment of this patient population. These data will be presented at the Presidential Symposium on Sunday, October 22.
First presentation of data from the Phase 3 CheckMate -77T trial of the perioperative regimen of neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo in patients with resectable stage IIA to IIIB NSCLC. CheckMate -77T is the second positive Phase 3 trial of an Opdivo-based combination for the treatment of non-metastatic NSCLC. These data will be presented at the Presidential Symposium on Saturday, October 21.
Late-breaking results from the Phase 3 CheckMate -816 study of neoadjuvant Opdivo with chemotherapy showing improved clinical benefit according to PD-L1 expression status in patients with resectable NSCLC. Additional CheckMate -816 results will also be presented showing efficacy benefits with Opdivo plus Yervoy in resectable NSCLC.
Updated results from the registrational TRIDENT-1 trial demonstrating clinical benefit with repotrectinib in patients with NTRK-positive advanced solid tumors, including NSCLC, who often develop resistance to existing therapies.
Seven-year efficacy results from the Phase 3 CheckMate -238 trial of adjuvant Opdivo in resected stage III/IV melanoma pointing to sustained benefits and reinforcing BMS’ leadership in earlier stages of melanoma.
Subgroup data from the Phase 2/3 RELATIVITY-047 trial showing consistent benefit across subgroups with the company’s third distinct checkpoint inhibitor Opdualag (nivolumab and relatlimab-rmbw) in the first-line treatment of patients with advanced melanoma.
Summary of Select Presentations:

Abstract Title

Author

Presentation

Type/#

Session Title

Session/Poster Discussion

Date/Time@

Adrenocortical Carcinoma

EO2401 (E) peptide immunotherapy + nivolumab (N) in adrenocortical carcinoma (ACC) and metastatic pheochromocytoma/paraganglioma (MPP); EOADR1-19/SPENCER

Eric Baudin

Proffered Paper

Abstract #724O

Proffered paper session – NETs and endocrine tumors

Sunday, October 22

08:30 – 10:00 CEST / 2:30 – 4:00 AM EDT

Gastrointestinal

Factors associated with uptake of adjuvant nivolumab in a nationwide esophageal cancer patient cohort

Robert Verhoeven

Poster

Abstract #1575P

Oesophagogastric cancer

Monday, October 23

Onsite poster display

Genitourinary

Nivolumab plus gemcitabine-cisplatin vs gemcitabine-cisplatin alone for previously untreated unresectable or metastatic urothelial carcinoma: results for cisplatin-eligible patients in the phase 3 CheckMate 901 trial

Michiel van der Heijden

Proffered Paper

Abstract

#LBA7

Presidential 2

Sunday, October 22

16:30 – 18:15 CEST / 10:30 AM – 12:15 PM EDT

Clinical management and outcomes of patients with advanced renal cell carcinoma (aRCC) treated with nivolumab+ipilimumab (N+I): a real-world study

Tom Geldart

Poster

Abstract #1896P

Renal cancer

Monday, October 23

Onsite poster display

Treatment patterns among novel hormonal therapy-experienced patients with metastatic castration-resistant prostate cancer

Vivek Narayan

Poster

Abstract #1824P

Prostate cancer

Sunday, October 22

Onsite poster display

STELLAR-304: A randomized phase 3 study of zanzalintinib (XL092) and nivolumab in non-clear cell renal cell carcinoma (nccRCC)

Sumanta Pal

Poster

Abstract #1912TiP

Renal cancer

Monday, October 23

Onsite poster display

Glioblastoma

Trotabresib (CC-90010) combined with concomitant temozolomide (TMZ) plus radiotherapy (RT) and adjuvant TMZ in patients (pts) with newly diagnosed primary glioblastoma (ndGBM): updated results from a phase 1b/2 study

Maria Vieito Villar

Proffered Paper

Abstract #500O

Proffered paper session – CNS tumors

Friday, October 20

16:00 – 17:30 CEST / 10:00-11:30 AM EDT

Gynecological

Antitumor activity of farletuzumab ecteribulin in a panel of endometrial cancer patient-derived xenografts with four different molecular subtypes

Kosei Hasegawa

Poster

Abstract #786P

Gynecological cancers

Sunday, October 22

Onsite poster display

A randomized, double-blind trial of nivolumab (NIVO) vs placebo (PBO) with neoadjuvant chemotherapy (NACT) followed by adjuvant endocrine therapy (ET) ± NIVO in patients (pts) with high-risk, ER+ HER2− primary breast cancer (BC)

Sherene Loi

Proffered Paper

Abstract #LBA20

Proffered paper session – Breast cancer, early stage

Friday, October 20

14:00 – 15:40 CEST / 8:00 – 9:40 AM EDT

Head and Neck

Nivolumab (nivo) in recurrent and/or metastatic squamous cell carcinoma of head and neck (R/M SCCHN): real-world effectiveness, quality of life (QoL) of patients and their caregivers in France (ProNiHN study)

Christophe Le Tourneau

Poster

Abstract #938P

Head and neck cancers, excl. thyroid

Sunday, October 22

Onsite poster display

Patients (pts) with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) treated with nivolumab (NIVO) in the first-line (1L) or later-line (2L+) settings in Germany: Updated results from the real-world HANNA study

Boris Kubuschok

Poster

Abstract #927P

Head and neck cancers, excl. thyroid

Sunday, October 22

Onsite poster display

Thoracic

CheckMate 77T: Phase 3 study comparing neoadjuvant nivolumab (NIVO) plus chemotherapy (chemo) vs neoadjuvant placebo plus chemo followed by surgery and adjuvant NIVO or placebo for previously untreated, resectable stage II–IIIB NSCLC

Tina Cascone

Proffered Paper

Abstract

#LBA1

Presidential 1

Saturday, October 21

16:30 – 18:15 CEST / 10:30 AM – 12:15 PM EDT

Neoadjuvant nivolumab (N) + ipilimumab (I) vs chemotherapy in the phase 3 CheckMate 816 trial

Mark Awad

Proffered Paper

Abstract #1261O

Proffered paper session – non-metastatic NSCLC and other thoracic malignancies

Friday, October 20

14:00 – 15:45 CEST / 8:00 – 9:45 AM EDT

Neoadjuvant nivolumab (N) + chemotherapy (C) in the phase 3 CheckMate 816 study: 3-y results by tumor PD-L1 expression

Mariano Provencio Pulla

Mini Oral

Abstract #LBA57

Mini oral session 2 – non-metastatic NSCLC and other thoracic malignancies

Monday, October 23

14:45 – 15:55 CEST / 8:45 – 9:55 AM EDT

Repotrectinib in patients (pts) with NTRK fusion-positive (NTRK+) advanced solid tumors, including NSCLC: Update from the phase 1/2 TRIDENT-1 trial

Ben Solomon

Poster

Abstract #1372P

NSCLC, metastatic

Monday, October 23

Onsite poster display

Nivolumab (nivo) resumption in patients with advanced or metastatic non-small cell lung cancer (aNSCLC): Survival outcomes based on France and Germany real-world data (RWD)

Maurice Pérol

Poster

Abstract #1455P

NSCLC, metastatic

Monday, October 23

Onsite poster display

First-line nivolumab (NIVO) plus ipilimumab (IPI) with two cycles of chemotherapy in patients with metastatic non-small cell lung cancer (NSCLC): Results from an interim analysis of the non-interventional FINN study

Jonas Kuon

Poster

Abstract #1448P

NSCLC, metastatic

Monday, October 23

Onsite poster display

SAPPHIRE: Phase 3 Study of sitravatinib Plus nivolumab Versus Docetaxel in Patients with Previously Treated Advanced Non-Squamous Non-Small Cell Lung Cancer

Hossein Borghaei

Proffered Paper

Abstract #LBA63

Proffered paper session – NSCLC, metastatic

Friday, October 20

16:00 – 17:30 CEST / 10:00 – 11:30 AM EDT

Melanoma

Adjuvant nivolumab (NIVO) vs ipilimumab (IPI) in resected stage III/IV melanoma: 7-y results from CheckMate 238

Paolo Ascierto

Poster

Abstract #1089P

Melanoma and other skin tumors

Sunday, October 22

Onsite poster display

Nivolumab (NIVO) plus relatlimab (RELA) vs NIVO in previously untreated metastatic or unresectable melanoma: 2-year subgroup analyses from RELATIVITY-047

Georgina Long

Poster

Abstract #1103P

Melanoma and other skin tumors

Sunday, October 22

Onsite poster display

Comparison of intracranial (IC) response assessment criteria in patients (pts) with melanoma brain metastases (MBM) treated with combination nivolumab (NIVO) plus ipilimumab (IPI) in CheckMate 204

Raymond Huang

Poster

Abstract #1135P

Melanoma and other skin tumors

Sunday, October 22

Onsite poster display

Unraveling relatlimab (RELA)-specific biology using biomarker analyses in patients with advanced melanoma treated with nivolumab (NIVO)+RELA or NIVO alone in RELATIVITY-047

Evan Lipson

Mini Oral

Abstract #LBA51

Mini oral session – Melanoma and other skin tumors

Saturday, October 21

14:45 – 16:10 CEST / 8:45 – 10:10 AM EDT

Evaluation of surrogate endpoints for overall survival within the RELATIVITY-047 trial

Peter Mohr

Poster

Abstract #1102P

Melanoma and other skin tumors

Sunday, October 22

Onsite poster display

Cross-Tumor/Solid Tumor

Recommended phase 2 dose (RP2D) selection and pharmacodynamic (PD) data of the first-in-human immune-stimulating antibody conjugate (ISAC) BDC-1001 in patients (pts) with advanced HER2-expressing solid tumors

Bob Li

Mini Oral

Abstract #657MO

Mini oral session – Developmental therapeutics

Monday, October 23

16:30 – 18:00 CEST / 10:30 AM – 12:00 PM EDT

Clinical benefit of immunotherapies in advanced cancer in France: a population-based estimate from 2014 to 2021

Isabelle Borget

Poster

Abstract #1752P

Policy and preventive strategies

Sunday, October 22

Onsite poster display

Early Assets

GUIDE.MRD: A Consortium Guiding Multi-Modal Therapies Against Minimal Residual Disease (MRD) by Liquid Biopsy to Assess Implementation of circulating tumor DNA (ctDNA) in Clinical Practice to Improve Patient Outcomes

Klaus Pantel

Poster

Abstract #237TiP

Biomarkers (agnostic)

Saturday, October 21

Onsite poster display

All abstracts except late-breaking abstracts will be available on the ESMO (Free ESMO Whitepaper) website at 00:05 CEST Monday, October 16 (6:05 PM EDT on Sunday, October 15). All late-breaking abstracts will be available on the ESMO (Free ESMO Whitepaper) website at 00:05 CEST on Thursday, October 19 (6:05 PM EDT on Wednesday, October 18).