On September 4, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that new data for four approved medicines and six pipeline candidates in more than 20 types of cancer will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 in Barcelona, Spain, from Sept. 13-17 (Press release, Merck & Co, SEP 4, 2024, View Source [SID1234646343]). Study findings from the Phase 3 KEYNOTE-522 trial (#LBA4) in high-risk early-stage triple-negative breast cancer (TNBC), the Phase 3 KEYNOTE-A18 trial (#709O) in high-risk locally advanced cervical cancer and the Phase 3 LEAP-012 trial (#LBA3) in unresectable, non-metastatic hepatocellular carcinoma, in collaboration with Eisai, have been selected for the ESMO (Free ESMO Whitepaper) Presidential Symposium Sessions. Data being shared at the Congress showcase the company’s continued progress in advancing clinical research for Merck’s broad portfolio and diverse pipeline of investigational candidates, with a total of 80 abstracts being presented.

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"Over the past decade, data on KEYTRUDA have contributed to paradigm shifts in the treatment of some of the deadliest forms of cancer and the rewriting of medical textbooks. We are very proud that today marks ten years since KEYTRUDA received its first approval in the U.S.," said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. "The compelling data for KEYTRUDA at this year’s ESMO (Free ESMO Whitepaper) are demonstrative of KEYTRUDA’s impressive journey, from 10-year survival data in unresectable or metastatic melanoma to new overall survival data in earlier stages of two types of women’s cancers. We’re also excited to show how we’re building on our leadership in oncology with data from our broad and diverse pipeline as we work toward improved outcomes for as many patients as possible."

Presentations at the Congress will feature new or updated findings from Merck’s broad portfolio of cancer medicines: KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy; WELIREG (belzutifan); LENVIMA (lenvatinib), in collaboration with Eisai; and LYNPARZA (olaparib), in collaboration with AstraZeneca.

Key data from Merck’s portfolio to be presented at ESMO (Free ESMO Whitepaper) Congress 2024:

First-time overall survival (OS) results from the Phase 3 KEYNOTE-522 trial evaluating KEYTRUDA in combination with chemotherapy as neoadjuvant treatment and then continuing as single agent as adjuvant treatment in patients with high-risk early-stage TNBC (Presentation #LBA4; Presidential Symposium II: Practice-changing trials).
OS data from the Phase 3 KEYNOTE-A18 trial evaluating KEYTRUDA in combination with concurrent chemoradiotherapy (CRT) as treatment for patients with high-risk locally advanced cervical cancer (Presentation #709O; Presidential Symposium I: Practice-changing trials).1
First presentation of results from the first interim analysis of the Phase 3 LEAP-012 trial evaluating KEYTRUDA plus LENVIMA in combination with transarterial chemoembolization (TACE) in patients with unresectable, non-metastatic hepatocellular carcinoma (Presentation #LBA3; Presidential Symposium I: Practice-changing trials).2
Ten-year OS data from the Phase 3 KEYNOTE-006 trial evaluating KEYTRUDA compared to ipilimumab as first-line treatment for patients with advanced melanoma (Presentation #LBA44; Mini oral session: Melanoma and other skin tumours).
OS data from the per protocol final analysis of the Phase 3 KEYNOTE-811 trial evaluating KEYTRUDA plus trastuzumab and chemotherapy as first-line treatment for patients with advanced human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma (Presentation #1400O; Proffered paper session 2: GI tumours, upper digestive).
Data from the per protocol final analysis of the Phase 3 LITESPARK-005 trial evaluating WELIREG as treatment for adult patients with advanced renal cell carcinoma that progressed following PD-1/L1 inhibitor and vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI) therapies (Presentation #LBA74; Proffered paper session 1: GU tumours, non-prostate).
Additionally, new data on investigational candidates from Merck’s pipeline will be presented at the Congress, including for: patritumab deruxtecan (HER3-DXd), a HER3-directed antibody-drug conjugate (ADC), and ifinatamab deruxtecan (I-DXd; also known as MK-2400) being developed in collaboration with Daiichi Sankyo; sacituzumab tirumotecan (sac-TMT; also known as MK-2870/SKB264), an investigational anti-TROP2 ADC being developed in collaboration with Kelun-Biotech; and opevesostat (also known as MK-5684/ODM-208), an investigational steroid synthesis inhibitor in collaboration with Orion.

Key data on investigational candidates from Merck’s pipeline to be presented at ESMO (Free ESMO Whitepaper) Congress 2024:

Data from the Phase 2 ICARUS-BREAST01 trial evaluating HER3-DXd as treatment for patients with hormone-receptor (HR)-positive/HER2-negative advanced breast cancer (Presentation #340O; Proffered paper session: Breast cancer, metastatic).3
First-time data from a Phase 2 study conducted in China, independently led by Kelun-Biotech, evaluating sac-TMT as treatment for patients with previously treated advanced endometrial carcinoma and ovarian cancer (Presentation #715MO; Mini oral session 2: Gynaecological cancers).4
Findings from a Phase 2 study conducted in China, independently led by Kelun-Biotech, evaluating sac-TMT plus KEYTRUDA as treatment for patients with recurrent or metastatic cervical cancer (Presentation #716MO; Mini oral session 2: Gynaecological cancers).4
Details on abstracts listed above and additional key abstracts for Merck

Breast cancer

Neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for high-risk early-stage TNBC: Overall survival results from the Phase 3 KEYNOTE-522 study. P. Schmid.

Presentation #LBA4, Presidential Symposium II: Practice-changing trials

Efficacy, safety and biomarker analysis of ICARUS-BREAST01: a Phase 2 Study of Patritumab Deruxtecan (HER3-DXd), in patients (pts) with HR+/HER2- advanced breast cancer (ABC). B. Pistilli.3

Presentation #340O, Proffered paper session: Breast cancer, metastatic

Intensified alkylating chemotherapy with autologous stem cell rescue (IACT) or conventional chemotherapy followed by olaparib (CCT-O) in stage III, HER2-negative, homologous recombination deficient (HRD) breast cancer (BC): Survival results of the randomized-controlled SUBITO trial. S. Linn.5

Presentation #LBA14, Mini oral session: Breast cancer, early stage

Gastrointestinal cancers

Transarterial Chemoembolization (TACE) With or Without Lenvatinib (len) + Pembrolizumab (pembro) for Intermediate-Stage Hepatocellular Carcinoma (HCC): Phase 3 LEAP-012 Study. J. Llovet.2

Presentation #LBA3, Presidential Symposium I: Practice-changing trials

Final overall survival for the Phase 3, KEYNOTE-811 study of pembrolizumab plus trastuzumab and chemotherapy for HER2+ advanced, unresectable or metastatic G/GEJ adenocarcinoma. S. Lonardi.

Presentation #1400O, Proffered paper session 2: GI tumours, upper digestive

Genitourinary cancers

Final analysis of the Phase 3 LITESPARK-005 study of belzutifan versus everolimus in participants (pts) with previously treated advanced clear cell renal cell carcinoma (ccRCC). B. I. Rini.

Presentation #LBA74, Proffered paper session 1: GU tumours, non-prostate

Opevesostat (MK-5684/ODM-208), an oral CYP11A1 inhibitor, in metastatic castration-resistant prostate cancer (mCRPC): updated CYPIDES Phase 2 results. K. Fizazi.6

Presentation #1605P, Poster

Alliance A031501: AMBASSADOR Study of Adjuvant Pembrolizumab (Pembro) in Muscle-Invasive Urothelial Carcinoma (MIUC) vs Observation (Obs): Extended follow-up disease-free survival (DFS) results and metastatic (met) disease recurrence distribution. A. B. Apolo.7

Presentation #1964MO, Mini oral session: GU tumours, non-prostate

Study EV-103 Dose Escalation/Cohort A (DE/A): 5y Follow-Up Of First-Line (1L) Enfortumab Vedotin (EV) + Pembrolizumab (P) in Cisplatin (cis)-Ineligible Locally Advanced Or Metastatic Urothelial Carcinoma (la/mUC). J. E. Rosenberg.8

Presentation #1968P, Poster

Preliminary Efficacy And Safety Of Disitamab Vedotin (DV) With Pembrolizumab (P) In Treatment (Tx)-Naive HER2-Expressing, Locally Advanced Or Metastatic Urothelial Carcinoma (la/mUC): RC48G001 Cohort C. M. D. Galsky.8

Presentation #1967MO, Mini oral session: GU tumours, non-prostate

Gynecologic cancers

Pembrolizumab plus chemoradiotherapy for high-risk locally advanced cervical cancer: Overall survival results from the randomized, double-blind, Phase 3 ENGOT-cx11/GOG-3047/KEYNOTE-A18 study. D. Lorusso.1

Presentation #709O, Presidential Symposium I: Practice-changing trials

Safety and Efficacy of Sacituzumab Tirumotecan (sac-TMT) in Patients (pts) with Previously Treated Advanced Endometrial Carcinoma (EC) and Ovarian Cancer (OC) from a Phase 2 Study. D. Wang.4

Presentation #715MO, Mini oral session 2: Gynaecological cancers

Efficacy and Safety of Sacituzumab Tirumotecan (sac-TMT) Plus Pembrolizumab in Patients with Recurrent or Metastatic Cervical Cancer. X. Wu.4

Presentation #716MO, Mini oral session 2: Gynaecological cancers

Lung cancer

Neoadjuvant Pembrolizumab (pembro) or Placebo (pbo) Plus Chemotherapy and Adjuvant Pembro or Pbo for Early-Stage NSCLC: Subgroup Analyses of the Phase 3 KEYNOTE-671 Study. M. C. Garassino.

Presentation #1210P, Poster

Ifinatamab deruxtecan (I-DXd; DS-7300) in patients with advanced solid tumors: Updated clinical and biomarker results from a phase I/II study. M. R. Patel. 3

Presentation #690P, Poster

Melanoma and other skin cancers

Pembrolizumab vs Ipilimumab in Advanced Melanoma: 10-Year Follow-Up of the Phase 3 KEYNOTE-006 Study. C. Robert

Presentation #LBA44, Mini oral session: Melanoma and other skin tumours

Pembrolizumab versus placebo after a complete resection of high-risk stage III melanoma: 7-year results of the EORTC 1325-MG/Keynote-054 double-blind Phase 3 trial. A. M. Eggermont.

Presentation #1095P, Poster

KEYMAKER-U02 substudy 02C: neoadjuvant pembrolizumab (pembro) and investigational agents followed by adjuvant pembro for stage IIIB-D melanoma. G. V. Long.

Presentation #1082O, Proffered paper session: Melanoma and other skin tumours

Pembrolizumab (pembro) vs placebo as adjuvant therapy for high-risk stage II melanoma: Long-term follow-up, rechallenge, and crossover in KEYNOTE-716. J. J. Luke.

Presentation #1078MO, Mini oral session: Melanoma and other skin tumours

KEYMAKER 02B: A randomized trial of pembrolizumab (pembro) alone or with investigational agents as first-line treatment for advanced melanoma. R. Dummer.

Presentation #1083P, Poster

Primary Results from TACTI-003: A Randomized Phase IIb Trial Comparing Eftilagimod Alpha (soluble LAG-3) Plus Pembrolizumab Versus Pembrolizumab Alone in First-Line Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with CPS ≥1. C. A. Kristensen.9

Presentation #LBA35, Proffered paper session: Head and neck cancer

1 In collaboration with the European Network for Gynaecological Oncology Trial (ENGOT) groups and the GOG Foundation, Inc. (GOG)
2 In collaboration with Eisai
3 In collaboration with Daiichi Sankyo
4 Independent study led by Kelun-Biotech
5 In collaboration with AstraZeneca
6 In collaboration with Orion Pharma
7 Sponsored by U.S. National Cancer Institute (NCI)/led by Alliance for Clinical Trials in Oncology
8 In collaboration with Astellas/Pfizer
9 In collaboration with Immutep

On September 4, 2024 Arsenal Biosciences, Inc. (ArsenalBio), a clinical stage programmable cell therapy company focused on engineering advanced CAR T-cell therapies for solid tumors, reported the close of an oversubscribed $325 million Series C financing round (Press release, ArsenalBio, SEP 4, 2024, View Source [SID1234646359]). The funding round included new investors ARCH Venture Partners, Milky Way Investments Group, Regeneron Ventures, NVentures (NVIDIA’s venture capital arm), Luma Group, funds and accounts advised by T. Rowe Price Associates, Inc., Rock Springs Capital, among others, with ongoing support from existing investors the Parker Institute for Cancer Immunotherapy (PICI), SoftBank Vision Fund 2, Bristol-Myers Squibb Company, Westlake Village BioPartners, Kleiner Perkins, Byers Capital, and Hitachi Ventures.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Proceeds from the financing will be used to advance ArsenalBio’s lead programs through development as the company continues to build its pipeline of therapeutic candidates for solid tumor cancers based on its proprietary T cell engineering technology, including logic gating. The funds will also drive further innovation in developing tools and processes for identifying new candidate cell therapies, helping ArsenalBio remain at the forefront of the rapidly evolving field of cell therapy, and bringing it closer to its goal of addressing unmet needs across the oncology category.

"Our initial clinical trials and preclinical studies have shown the promise of our T cell engineering approach and have given us the confidence to broaden the application of our technology to address additional cancer types," said Ken Drazan, M.D., ArsenalBio’s co-founder, CEO and Chairman. "This new investment enables us to continue our development roadmap, scale up our manufacturing capabilities, and invest in new avenues for innovation in T cell medicine."

ArsenalBio’s robust pipeline includes potential therapies in development for ovarian, kidney, and prostate cancers, as well as other solid tumors being co-developed through a collaboration with Bristol-Myers Squibb Company. The fundraising follows ArsenalBio’s recent entry into clinic with its second T cell product candidate, AB-2100, being studied in a Phase 1/2 clinical trial for clear-cell renal cell carcinoma (ccRCC). The candidate has been granted Fast Track designation by the U.S. Food and Drug Administration.

On September 4, 2024 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer patients, reported that Chandler D. Robinson, MD, Monopar’s Chief Executive Officer, will present at the H.C. Wainwright 26th Annual Global Investment Conference (Press release, Monopar Therapeutics, SEP 4, 2024, https://ir.monopartx.com/news/detail/100/monopar-to-participate-in-theh-c-wainwright-26th-annual-global-investment-conference [SID1234646344]). The Company’s presentation will be webcast beginning on Monday, September 9, 2024 at 7:00 a.m. ET. In person one-on-one meetings will take place at the Lotte New York Palace, NY, NY from September 9 – 11, 2024.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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On September 4, 2024 Daiichi Sankyo (TSE: 4568) reported that it will present new clinical research across its antibody drug conjugate (ADC) portfolio with more than 25 abstracts across multiple types of cancer at the IASLC 2024 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC24) and the 2024 European Society for Medical Oncology (#ESMO24) (Press release, Daiichi Sankyo, SEP 4, 2024, https://www.businesswire.com/news/home/20240903292956/en/Daiichi-Sankyo-Unveils-New-Research-Across-Industry-Leading-ADC-Portfolio-in-Multiple-Cancers-at-WCLC-and-ESMO [SID1234646360]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Data at WCLC and ESMO (Free ESMO Whitepaper) showcasing Daiichi Sankyo’s progress towards its goal of creating new standards of care for patients with cancer will include six late-breaking presentations, including two back-to-back presentations during Presidential Symposium 1 featuring datopotamab deruxtecan (Dato-DXd) data at WCLC, and the first presentation of clinical data of DS-9606, a CLDN6 directed modified pyrrolobenzodiazepine (PBD) ADC from Daiichi Sankyo’s second ADC platform, at ESMO (Free ESMO Whitepaper).

"New data in lung, breast, gastric, ovarian, endometrial and other cancers from several of our DXd antibody drug conjugates demonstrates how we are making substantial progress toward creating new standards of care for patients with cancer," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "We look forward to presenting initial clinical data from our second antibody drug conjugate platform at ESMO (Free ESMO Whitepaper), which underscores how Daiichi Sankyo is applying our expertise in this technology to craft new innovation for patients."

Progress in Lung Cancer at WCLC and ESMO (Free ESMO Whitepaper)
Late-breaking data at WCLC to be reported during back-to-back presentations at Presidential Symposium 1 will highlight the first interim results from the NeoCOAST-2 phase 2 platform trial evaluating novel perioperative treatment combinations including one arm studying datopotamab deruxtecan with durvalumab and chemotherapy as neoadjuvant treatment followed by adjuvant treatment with durvalumab in patients with resectable early-stage (IIA to IIIB) non-small cell lung cancer (NSCLC).

The second Presidential Symposium 1 presentation will feature results from the application of quantitative continuous scoring (QCS), AstraZeneca’s proprietary computational pathology platform, to measure TROP2 in tissue samples collected in the TROPION-Lung01 phase 3 trial that evaluated datopotamab deruxtecan versus docetaxel in patients with locally advanced or metastatic NSCLC treated with at least one prior line of therapy. Overall survival results from TROPION-Lung01 also will be presented as a late-breaking oral presentation.

Other data at WCLC include two oral presentations featuring the interim results from the dose optimization part of the IDeate-Lung01 phase 2 trial of ifinatamab deruxtecan (I-DXd) in patients with pretreated extensive-stage small cell lung cancer and results from the ENHERTU (trastuzumab deruxtecan) monotherapy arm of the DESTINY-Lung03 phase 1b trial in patients with previously treated HER2 overexpressing unresectable, locally advanced or metastatic NSCLC. A trial-in-progress poster from the NSCLC cohort of a phase 1b trial evaluating the combination of datopotamab deruxtecan and valemetostat, a dual inhibitor of EZH1 and EZH2, in previously treated locally advanced, unresectable or metastatic nonsquamous NSCLC with or without actionable genomic alterations also will be highlighted.

At ESMO (Free ESMO Whitepaper), additional data in lung cancer being reported include poster presentations featuring a post-hoc analysis of patients with nonsquamous NSCLC by baseline brain metastases status in the TROPION-Lung01 phase 3 trial of datopotamab deruxtecan and intracranial responses seen in the IDeate-Lung01 phase 2 trial of ifinatamab deruxtecan, as well as a trial-in-progress poster featuring the design of the IDeate-Lung03 phase 1b/2 trial of ifinatamab deruxtecan in combination with atezolizumab with or without carboplatin as first-line induction or maintenance therapy in patients with extensive-stage small cell lung cancer.

Continued Innovation in Breast Cancer at ESMO (Free ESMO Whitepaper)
Late-breaking presentations in breast cancer at ESMO (Free ESMO Whitepaper) will include a proffered paper session featuring the primary results of the DESTINY-Breast12 phase 3b/4 trial evaluating ENHERTU in patients with HER2 positive advanced or metastatic breast cancer with or without brain metastases, and two mini oral sessions highlighting patient reported outcomes and determination of the HER2 low and HER2 ultralow status of tumors from the DESTINY-Breast06 phase 3 trial in patients with HR positive, HER2 low and HER2 ultralow metastatic breast cancer.

Two proffered paper sessions will highlight results from the ICARUS-BREAST01 phase 2 study of patritumab deruxtecan (HER3-DXd) in patients with HR positive, HER2 negative advanced breast cancer with disease progression following two or more treatments and the investigator-initiated ERICA phase 2 trial evaluating olanzapine-based triplet antiemetic therapy for prevention of nausea and vomiting in combination with ENHERTU in patients with metastatic breast cancer. A mini oral session will feature a supplementary biomarker analysis from the DAISY phase 2 trial evaluating ENHERTU in three cohorts of patients with HER2 expressing metastatic breast cancer and a poster presentation will report on an exploratory biomarker analysis of ENHERTU in patients with HR positive, HER2 low metastatic breast cancer from the DESTINY-Breast04 phase 3 trial. A poster reporting on exposure-adjusted incidence rates of adverse events from the TROPION-Breast01 phase 3 trial of datopotamab deruxtecan versus chemotherapy in patients with previously treated HR positive, HER2 negative metastatic breast cancer also will be featured.

Data from Daiichi Sankyo’s Second ADC Platform and DXd ADC Data in Multiple Additional Cancers at ESMO (Free ESMO Whitepaper)
At ESMO (Free ESMO Whitepaper), a proffered paper session will highlight preliminary results from a phase 1 trial of DS-9606, a CLDN6 directed modified PBD ADC from Daiichi Sankyo’s second ADC platform, in patients with solid tumors known to express CLDN6. Results from the DESTINY-Gastric03 phase 1b/2 trial evaluating ENHERTU monotherapy or ENHERTU combinations with chemotherapy and/or immunotherapy in patients with HER2 expressing advanced/metastatic gastric or gastroesophageal junction carcinoma also will be presented at a proffered paper session.

A mini oral session will feature results from the TROPION-PanTumor03 phase 2 trial of datopotamab deruxtecan in patients with previously treated recurrent endometrial or ovarian cancer. Trial-in-progress poster presentations will highlight the HERTHENA-PanTumor01 phase 2 trial evaluating patritumab deruxtecan in patients with a broad range of solid tumors including bladder, cervical, endometrial, esophageal, gastric, head and neck, melanoma, ovarian, pancreatic and prostate and a phase 1 trial of DS-1471, a CD147 monoclonal antibody, in patients with locally advanced or metastatic solid cancers.

Investor Conference Call Following ESMO (Free ESMO Whitepaper)
Daiichi Sankyo will hold a virtual conference call for investors on Tuesday, September 17, 2024 from 8:00 to 9:30 am EDT / 9:00 to 10:30 pm JST. Executives from Daiichi Sankyo will provide an overview of the WCLC and ESMO (Free ESMO Whitepaper) research data and address questions.

WCLC and ESMO (Free ESMO Whitepaper) Data Highlights
Highlights of data from Daiichi Sankyo’s ADC portfolio at WCLC 2024 include:

Presentation Title

Author

Abstract

Presentation (PDT)

NSCLC

NeoCOAST-2: efficacy and safety of neoadjuvant durvalumab (D) + novel anticancer agents + CT and adjuvant D ± novel agents in resectable NSCLC

T. Cascone

PL02.07

Presidential Symposium 1
Sunday, September 8
8:30 – 10:00 am

Normalized membrane ratio of TROP2 by quantitative continuous scoring is predictive of clinical outcomes in TROPION-Lung01

M.C. Garassino

PL02.11

Presidential Symposium 1
Sunday, September 8
8:30 – 10:00 am

Datopotamab deruxtecan vs docetaxel in patients with non-small cell lung cancer: final overall survival from TROPION-Lung01

J. Sands

OA08.03

Oral Presentation
Monday, September 9
10:45 – 12:00 pm

Trastuzumab deruxtecan monotherapy in pretreated HER2 overexpressing nonsquamous non-small cell lung cancer: DESTINY-Lung03 part 1

D. Planchard

OA16.05

Oral Presentation
Tuesday, September 10
1:30 – 2:45 pm

Valemetostat and datopotamab deruxtecan in previously treated, advanced, unresectable, or metastatic non-squamous NSCLC

A. Spira

P2.10A.04

Poster Session

Sunday, September 8

6:15 – 7:45 pm

SCLC

Ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer (ES-SCLC): interim analysis of IDeate-Lung01

C. Rudin

OA04.03

Oral Presentation
Sunday, September 8
2:00 – 3:15 pm

Exposure-response analyses to support phase 3 dose selection for I-DXd (ifinatamab deruxtecan) in extensive stage SCLC patients

N. Midde

P1.13A.12

Poster Session
Sunday, September 8
12:00 – 2:00 pm

Highlights of data from Daiichi Sankyo’s ADC portfolio at ESMO (Free ESMO Whitepaper) 2024 include:

Presentation Title

Author

Abstract

Presentation (CEST)

NSCLC

Datopotamab deruxtecan (Dato-DXd) vs docetaxel in patients with advanced nonsquamous non-small cell lung cancer with brain metastases: results from TROPION-Lung01

E. Pons-Tostivint

1312P

Poster Session
Saturday, September 14

SCLC

Intracranial response in patients with baseline brain metastases and extensive-stage small cell lung cancer treated with ifinatamab deruxtecan (I-DXd) in the IDeate-Lung01 study

M. Johnson

1787P

Poster Session
Saturday, September 14

IDeate-Lung03: a phase 1b/2 study of ifinatamab deruxtecan (I-DXd) plus atezolizumab with or without carboplatin as first line induction or maintenance in patients with extensive stage small cell lung cancer

C. Rudin

1812TiP

Poster Session
Saturday, September 14

BREAST

Trastuzumab deruxtecan (T-DXd) in patients with HER2+ advanced/metastatic breast cancer with or without brain metastases: primary results from DESTINY-Breast12

N. Lin

LBA18

Proffered Paper Session
Friday, September 13
4:00 – 5:30 pm

HER2 low and HER2 ultralow status determination in tumors of patients with HR+ mBC in DESTINY-Breast06

G. Viale

LBA 21

Mini Oral Session
Sunday, September 15
8:30 – 10:00 am

Effects of trastuzumab deruxtecan (T-DXd) vs treatment of physician’s choice on patient-reported outcomes in hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2) low/ultralow metastatic breast cancer: results from DESTINY-Breast06

X. Hu

LBA22

Mini Oral Session
Sunday, September 15
8:30 – 10:00 am

Efficacy, safety and biomarker analysis of ICARUS-BREAST01: a phase 2 study of patritumab deruxtecan (HER3-DXd) in patients with HR+/HER2- advanced breast cancer

B. Pistilli

340O

Proffered Paper Session
Friday, September 13
4:00 – 5:30 pm

A multicenter, randomized, double-blind, placebo-controlled study of olanzapine-based triplet antiemetic therapy for prevention of delayed and persistent nausea and vomiting induced by trastuzumab deruxtecan in patients with metastatic breast cancer: ERICA study

H. Sakai

1816O

Proffered Paper Session
Saturday, September 14
2:45 – 4:25 pm

Unraveling the mechanisms of action and resistance to trastuzumab deruxtecan (T-DXd): supplementary biomarker analyses from DAISY trial

F. Mosele

343MO

Mini Oral Session
Sunday, September 15
8:30 – 10:00 am

Exploratory biomarker analysis of trastuzumab deruxtecan versus treatment of physician’s choice in HER2-low, hormone receptor-positive metastatic breast cancer in DESTINY-Breast04

N. Ueno

432P

Poster Session
Monday, September 16

Exposure-adjusted incidence rates of adverse events from the TROPION-Breast01 study of datopotamab deruxtecan (Dato-DXd) vs investigator’s choice of chemotherapy in patients with pretreated, inoperable/ metastatic HR+/HER2- breast cancer

H. Rugo

431P

Poster Session
Monday, September 16

Treatment patterns and outcomes in HER2 low, HR+ metastatic breast cancer patients previously treated with endocrine therapy in the United States

S. Modi

399P

Poster Session
Monday, September 16

OTHER SOLID TUMORS

Preliminary results from a phase 1, first-in-human study of DS-9606a, a Claudin 6 (CLDN6) directed antibody drug conjugate, in patients with tumor types known to express CLDN6

M. Patel

610O

Proffered Paper Session
Sunday, September 15
2:45 – 4:15 pm

Trastuzumab deruxtecan (T-DXd) monotherapy and combinations in patients with advanced/metastatic HER2 positive esophageal, gastric or gastroesophageal junction adenocarcinoma: DESTINY-Gastric03

Y. Janjigian

1401O

Proffered Paper Session
Saturday, September 14
8:30 – 10:00 am

Datopotamab deruxtecan (Dato-DXd) monotherapy in patients with endometrial or ovarian cancer: results from the phase 2 TROPION-PanTumor03 study

A.

Oaknin

714MO

Mini Oral Session
Sunday, September 15
2:45 – 4:15 pm

HERTHENA-PanTumor01: A global phase 2 trial of HER3-DXd in metastatic solid tumors

T. Powles

690TiP

Poster Session
Saturday, September 14

A phase 1, first-in-human study of DS-1471 in patients with advanced/metastatic solid tumors

S. Koganemaru

682TiP

Poster Session
Saturday, September 14

Claudin-6 expression in primary and recurrent epithelial ovarian cancer: a potential therapeutic target for high-grade serous ovarian cancer

D. Shintani

771P

Poster Session
Saturday, September 14

About the ADC Portfolio of Daiichi Sankyo
The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo.

The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and datopotamab deruxtecan (Dato-DXd), a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo.

The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified PBD payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform.

Datopotamab deruxtecan, ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.

On September 4, 2024 Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene elimination, gene insertion, and gene excision, reported that the Company will participate in a panel discussion and fireside chat at the H.C. Wainwright 26th Annual Global Healthcare Conference taking place September 9-11, 2024 in New York (Press release, Precision Biosciences, SEP 4, 2024, View Source [SID1234646345]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Details are as follows:

Panel: Cutting-Edge Approaches to Viral Hepatitis: Is a Cure on the Horizon?
Date: September 9, 2024
Time: 11:00-12:00PM ET
Presenter: Cassie Gorsuch, Ph.D., Vice President, Gene Therapy Discovery

Fireside Chat:
Date: September 10, 2024
Time: 5:00-5:30PM ET
Webcast Registration: Link

The Fireside Chat will be available on Precision’s website in the Investors section under Events & Presentations on at investor.precisionbiosciences.com. An archived replay will be available for approximately 30 days following the event. Please contact your H.C. Wainwright representative for details regarding access to the panel presentation.