On December 2, 2024 Agendia, Inc. reported the publication of a pivotal secondary analysis from the IDEAL randomized Phase 3 clinical trial in JAMA Network Open (Press release, Agendia, DEC 2, 2024, View Source [SID1234648742]). The study highlights the ability of the MammaPrint (MP) genomic assay to predict benefit of extended endocrine therapy (EET) in post-menopausal patients with early-stage, hormone receptor positive (HR+) breast cancer.

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The published study, titled Selection of Patients with Early-Stage Breast Cancer for Extended Endocrine Therapy: A Second Analysis of the IDEAL Randomized Clinical Trial, corroborates prior findings published from the NSABP B-42 trial, demonstrating that MP can identify patients who benefit most from EET and those with minimal benefit who can avoid associated side effects, thus optimizing adjuvant treatment decisions beyond traditional clinical risk factors.

This secondary analysis focused on MammaPrint’s predictive capacity of EET in preventing late recurrences among a translational cohort of 515 IDEAL patients. The cohort consisted of post-menopausal, hormone receptor-positive early breast cancer patients who were randomized to receiving 2.5- or 5-years of extended letrozole therapy after completing an initial 5 years of endocrine therapy. The original study did not show any benefit of 5 years over 2.5 years of endocrine therapy, however, through analysis using genomic profiling with MammaPrint, this study was able to identify a subset of patients who will benefit from EET. Key findings from the study include:

Significant benefit for MP Low-Risk Patients: MP Low-Risk patients derived the largest benefit from extended letrozole treatment at 10 years post-randomization. Researchers found an absolute benefit of 10.1% for distant recurrence (DR), 11.7% for recurrence-free interval (RFI), and 9.7% for breast cancer-free interval (BCFI) for MP Low-Risk patients. The effect of letrozole on the 10-year RFI rate was significantly dependent on MammaPrint classification.
No EET Benefit for MP High-Risk Patients: Patients with MP High-Risk tumors are more likely to relapse within the first 5 years of diagnosis and as evidenced by the results of the study, derive less benefit from extending endocrine therapy beyond the initial 5-years post-diagnosis.
Ultra-Low-Risk Findings: Although few patients in the cohort had a MP Ultra-Low tumor, they did not derive any EET benefit for the above endpoints, which is consistent with B42 where a larger number of ultralow patients were analyzed.
"By demonstrating MammaPrint’s ability to predict the benefit from extended endocrine therapy based on genomic risk, particularly the recurrence-free interval for Low-Risk patients, physicians are now better equipped to identify which patients will benefit from this treatment," said Laura van ‘t Veer, PhD, Professor of Laboratory Medicine, Co-Leader of the Breast Oncology Program and Director of Applied Genomics at the Helen Diller Family Comprehensive Cancer Center, University of California, Chief Research Officer and Co-Founder of Agendia. "These findings provide clinicians with a powerful tool to optimize endocrine treatment duration, potentially sparing MP High-Risk patients from unnecessary extended therapy while ensuring MP Low-Risk patients receive the full protective benefits they need."

"These data build upon the evidence gathered from the NSABP-42 study, providing further validation of MammaPrint’s genomic profiling to help refine treatment strategies and identify patients who are more likely to benefit from extended endocrine therapy," said William Audeh, MD, MS, Chief Medical Officer of Agendia. "We know that some hormone-positive breast cancer may have a risk for late recurrences, beyond five years, and these data show that MammaPrint can predict which of those recurrences are preventable by EET. Because MammaPrint looks at the biology of the tumor early in the treatment cycle, it can distinguish Low-Risk patients who will derive substantial benefit from extended endocrine therapy from High-Risk patients who will not. This approach not only optimizes therapeutic efficacy, but also minimizes unnecessary treatment for those unlikely to benefit, thereby enhancing overall patient care."

The data from both IDEAL and NSABP-B42 validate MP’s predictive ability to determine which patients will benefit from EET and which can avoid it, potentially improving long-term survival outcomes and quality of life. These findings expand MP’s clinical utility beyond guiding neoadjuvant and adjuvant chemotherapy decisions and towards optimizing the duration of adjuvant endocrine treatment.

On December 2, 2024 Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) and Novocure (NASDAQ: NVCR) reported that the pivotal, Phase 3 PANOVA-3 trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival (mOS) versus control. PANOVA-3 evaluated the use of Tumor Treating Fields (TTFields) therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma (Press release, Zai Laboratory, DEC 2, 2024, View Source [SID1234648741]).

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"As a researcher and clinician, I have experienced the challenges of developing treatments in pancreatic cancer. It is exciting to see the PANOVA-3 trial achieve the positive primary endpoint of overall survival, a landmark outcome for this field," said Vincent Picozzi, M.D., medical oncologist and investigator in the PANOVA-3 trial. "These data for Tumor Treating Fields are very promising, especially in this difficult to treat patient population."

In the intent-to-treat population, patients treated with TTFields therapy concomitant with gemcitabine and nab-paclitaxel had an mOS of 16.20 months compared to 14.16 months in patients treated with gemcitabine and nab-paclitaxel alone, a statistically significant 2.0-month improvement (hazard ratio=0.819; P=0.039) (N=571). The survival rate benefit for patients treated with TTFields therapy increased over time with a 13% improvement in the overall survival rate at 12 months and a 33% improvement in survival rate at 24 months. TTFields therapy was well-tolerated, and safety was consistent with prior clinical studies.

"PANOVA-3 is the first and only Phase 3 trial to demonstrate a statistically significant benefit in overall survival specifically in unresectable, locally advanced pancreatic cancer, and is Novocure’s third positive Phase 3 clinical trial in the last two years," said Nicolas Leupin, M.D., PhD, Chief Medical Officer, Novocure. "We are grateful to the patients and investigators for their participation in the trial, and we look forward to sharing the full data at an upcoming medical conference."

"There are approximately 134,000 new cases of pancreatic cancer diagnosed annually in China, and this cancer is one of the most challenging to treat globally, with limited effective treatment options and poor survival outcomes," said Dr. Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. "Demonstrating a statistically significant and clinically meaningful improvement in overall survival for patients with unresectable, locally advanced pancreatic cancer is an important achievement. We are pleased to have been able to contribute to the PANOVA-3 study, and we look forward to working with Novocure to bring this therapy to patients as soon as possible."

Novocure plans to file for regulatory approval of TTFields in unresectable, locally advanced pancreatic adenocarcinoma based on PANOVA-3 and plans to submit the PANOVA-3 results for presentation at an upcoming medical congress. Zai Lab plans to file for regulatory approval in China.

About PANOVA-3

PANOVA-3 is a prospective, randomized open-label, controlled Phase 3 clinical trial designed to test the efficacy and safety of Tumor Treating Fields (TTFields) therapy used concomitantly with gemcitabine and nab-paclitaxel, as a first-line treatment of locally advanced pancreatic adenocarcinoma. Patients were randomized to receive either TTFields therapy concomitant with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone.

The primary endpoint is overall survival. Secondary endpoints include progression free survival, local progression free survival, objective response rate, one-year survival rate, quality of life, pain-free survival, puncture-free survival, resectability rate, and toxicity.

A total of 571 patients were enrolled in the study, randomized 1:1 and followed for a minimum of 18 months.

About Pancreatic Cancer in China

Pancreatic cancer is one of the most common and deadliest cancers globally. In China, there were an estimated 134,374 new cases in 2022, and it is now the eighth most common cancer type1. The current median survival of patients with locally advanced, unresectable pancreatic cancer is nine to twelve months, and the five-year survival rate was 7.2%2, making it the malignancy with the lowest survival rate in China.

About Tumor Treating Fields

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. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these 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 TTFields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

On December 2, 2024 Daiichi Sankyo (TSE: 4568) reported that it will present new clinical research across its oncology portfolio with more than 45 abstracts in multiple types of solid and blood cancers at the 2024 ESMO (Free ESMO Whitepaper) Asia Congress (#ESMOAsia24), San Antonio Breast Cancer Symposium (#SABCS24) and American Society of Hematology (ASH) (Free ASH Whitepaper) (#ASH24) Annual Meeting prior to its Science & Technology Day (Press release, Daiichi Sankyo, DEC 2, 2024, https://www.businesswire.com/news/home/20241127957948/en/Daiichi-Sankyo-Highlights-Progress-Across-Oncology-Portfolio-in-Multiple-Solid-and-Blood-Cancers-at-ESMO-Asia-SABCS-and-ASH [SID1234648740]).

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Data at ESMO (Free ESMO Whitepaper) Asia, SABCS and ASH (Free ASH Whitepaper) will showcase Daiichi Sankyo’s progress towards its goal of creating new standards of care for patients with cancer. Highlights include three late-breaking presentations, including a pooled analysis of data from the TROPION-Lung05 phase 2 and TROPION-Lung01 phase 3 trials of datopotamab deruxtecan (Dato-DXd) in patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC) at ESMO (Free ESMO Whitepaper) Asia, as well as a subgroup analysis from the DESTINY-Breast06 phase 3 trial of ENHERTU (trastuzumab deruxtecan) in patients with unresectable or metastatic HR positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer and the primary analysis from the VALENTINE phase 2 trial of patritumab deruxtecan (HER3-DXd) in patients with early HR positive, HER2 negative breast cancer at SABCS.

"Important updates in difficult-to-treat cancers including lung, breast, gastric and biliary tract cancer as well as acute myeloid leukemia and peripheral T-cell lymphoma will be highlighted at these upcoming meetings," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "We continue to make important progress with our approved and pipeline medicines with the goal of changing the standard of care across a wide range of cancers."

Innovation in Lung, Breast, Gastric and Biliary Tract Cancer at ESMO (Free ESMO Whitepaper) Asia
Late-breaking data at ESMO (Free ESMO Whitepaper) Asia will highlight a pooled analysis of results from the TROPION-Lung05 phase 2 and TROPION-Lung01 phase 3 trials of datopotamab deruxtecan in patients with previously treated EGFR-mutated advanced NSCLC during a proffered paper session.

Two mini oral presentations will feature results of the TROPION-Breast01 phase 3 trial of datopotamab deruxtecan in Chinese patients with previously treated metastatic HR positive, HER2 low or negative breast cancer and the final results of the DESTINY-Gastric06 phase 2 trial of ENHERTU in Chinese patients with previously treated HER2 positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Results of DESTINY-Gastric06 led to the recent conditional approval in China of ENHERTU as a monotherapy for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or GEJ adenocarcinoma who have received two or more prior treatment regimens.

Trials-in-progress posters also will feature the trial designs of three ongoing ENHERTU clinical trials, including the DESTINY-BTC01 phase 3 trial that will evaluate ENHERTU with rilvegostomig, AstraZeneca’s PD-1/TIGIT bispecific antibody, versus standard of care in patients with previously untreated HER2 expressing, locally advanced or metastatic biliary tract cancer, and the DESTINY-Gastric03 phase 1b/2 trial where a new arm has been added to evaluate ENHERTU in combination with rilvegostomig and chemotherapy in patients with HER2 positive or HER2 low gastric or GEJ adenocarcinoma. A second part of the DESTINY-PanTumor02 phase 2 trial of ENHERTU also will be presented where patients with previously treated HER2 expressing metastatic solid tumors will be enrolled into one of five new cohorts: patients with any tumor expressing HER2 IHC 3+ (excluding breast, gastric and colorectal cancer); patients with any tumor expressing HER2 IHC 2+/ISH+ (excluding breast, gastric and colorectal cancer); patients with HER2 IHC 2+/1+ endometrial cancer; patients with HER2 IHC 2+/1+ ovarian cancer; and patients with HER2 IHC 2+/1+ cervical cancer.

Continued Progress in Breast Cancer at SABCS
Late-breaking presentations in breast cancer at SABCS will include two oral presentations featuring a subgroup analysis of the DESTINY-Breast06 phase 3 trial reporting on the impact of response to prior endocrine-based therapy on outcomes in patients with unresectable or metastatic HR positive, HER2 low or HER2 ultralow breast cancer who failed at least one line of endocrine therapy receiving ENHERTU compared to chemotherapy, and the primary results from the VALENTINE phase 2 trial evaluating neoadjuvant patritumab deruxtecan (HER3-DXd) alone or in combination with letrozole in patients with high-risk HR positive, HER2 negative early breast cancer.

Other data at SABCS includes two spotlight poster presentations highlighting the first exploratory biomarker analysis assessing the impact of genomic alterations on the efficacy of ENHERTU compared to ado-trastuzumab emtansine (T-DM1) in patients with HER2 positive metastatic breast cancer from the DESTINY-Breast03 phase 3 trial, and the effects of ENHERTU on health-related quality of life and neurological function from the DESTINY-Breast12 phase 3b/4 trial in patients with previously treated HER2 positive metastatic breast cancer with or without brain metastases. Final results from the dose expansion portion of the DESTINY-Breast08 phase 1b trial evaluating ENHERTU in combination with capecitabine or capivasertib in patients with HER2 low metastatic breast cancer also will be presented as a poster presentation.

Trial-in-progress posters will feature the trial designs from a sub-protocol of a phase 1b master protocol trial evaluating ENHERTU in combination with valemetostat, a dual EZH1 and EZH2 inhibitor, in patients with previously treated HER2 low unresectable or metastatic breast cancer as well as a phase 1b trial evaluating the combination in patients with previously treated HER2 low, HER2 ultralow or HER2 null metastatic breast cancer.

Updates in Hematology Portfolio in Certain Leukemias and Lymphomas
At ASH (Free ASH Whitepaper), several sub-analyses of the QuANTUM-First phase 3 trial of VANFLYTA (quizartinib) in patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) will be presented. An oral presentation will highlight data on the frequency of co-mutations in trial patients and their impact on remission rate, overall survival and relapse-free survival. Three poster presentations will report new data, including the impact of continuation therapy on the efficacy of VANFLYTA, focusing on measurable residual disease status; a concordance between utilizing a FLT3-ITD mutation detection clinical trial assay and a next-generation sequencing measurable residual disease assay; and a matching adjusted indirect comparison analysis of VANFLYTA compared to midostaurin in patients with newly diagnosed FLT3-ITD AML.

Additionally, several poster presentations will report on the QUIWI phase 2 trial that evaluated VANFLYTA in combination with standard chemotherapy in patients with newly diagnosed FLT3-ITD negative AML, including the final results of QUIWI and sub-analyses of the trial by mutational status, including FLT3-TKD and NPM1, and ELN risk categorization. The QUIWI phase 2 trial formed the basis of the QuANTUM-Wild phase 3 trial that is further evaluating the addition of VANFLYTA to standard chemotherapy in this patient population. The design of the QuANTUM-Wild phase 3 trial will be highlighted as a trial-in-progress poster.

Other data at ASH (Free ASH Whitepaper) includes two poster presentations reporting the primary results of the VALYM phase 2 trial of valemetostat in patients with relapsed or refractory large B-cell lymphoma and an exploratory analysis of circulating tumor DNA, a novel biomarker, to potentially predict clinical response to valemetostat from the VALENTINE-PTCL01 phase 2 trial in patients with relapsed or refractory peripheral T-cell lymphoma, which was recently published in The Lancet Oncology.

Science & Technology Day
Daiichi Sankyo will hold "Science & Technology Day," formerly called R&D Day, for investors on Monday, December 16, 2024 from 5:30 to 7:30 pm EST / Tuesday, December 17 from 7:30 to 9:30 am JST. Executives from Daiichi Sankyo will provide an overview of the ESMO (Free ESMO Whitepaper) Asia, SABCS and ASH (Free ASH Whitepaper) research data and provide updates on R&D strategy.

ESMO Asia, SABCS and ASH (Free ASH Whitepaper) Data Highlights
Highlights of data from Daiichi Sankyo’s DXd ADC portfolio at ESMO (Free ESMO Whitepaper) Asia 2024 include:

Presentation Title

Author

Abstract

Presentation (SGT)

Datopotamab Deruxtecan (Dato-DXd)

Lung Cancer

Efficacy and safety of datopotamab deruxtecan (Dato-DXd) in patients with previously treated EGFR-mutated advanced non-small cell lung cancer: a pooled analysis of TROPION-Lung01 and TROPION-Lung05

M. Ahn

LBA7

Proffered Paper Session

Friday, December 6

10:15 – 11:45 am

Breast Cancer

Datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with pre-treated inoperable/metastatic hormone receptor positive, HER2 negative breast cancer: results from TROPION-Breast01 China cohort

S. Wang

38MO

Mini Oral Session

Saturday, December 7

2:30 – 3:40 pm

ENHERTU (trastuzumab deruxtecan; T-DXd)

Gastric

Cancer

Trastuzumab deruxtecan (T-DXd) in Chinese patients with previously treated HER2 positive advanced gastric or gastroesophageal junction adenocarcinoma: DESTINY-Gastric06 final analysis

Z. Peng

129MO

Mini Oral Session

Saturday, December 7

9:00 – 10:40 am

A phase 1b/2 open-label study evaluating trastuzumab deruxtecan (T-DXd) in combination with rilvegostomig and chemotherapy in patients with HER2 positive and HER2 low gastric or gastroesophageal junction adenocarcinoma: DESTINY-Gastric03 part 4

Y. Janjigian

264TiP

Poster Session

December 7, 2024

5:50 – 6:45 pm

PanTumor

Randomized, open-label, multicenter, phase 3 study of trastuzumab deruxtecan (T-DXd) with rilvegostomig vs standard of care in first-line HER2 expressing, locally advanced or metastatic biliary tract cancer: DESTINY-BTC01

M. Ikeda

261TiP

Poster Session

December 7, 2024

5:50 – 6:45 pm

An open-label, multicenter, phase 2 study of trastuzumab deruxtecan (T-DXd) in patients with HER2 expressing solid tumors: DESTINY-PanTumor02 part 2

J. Lee

400TiP

Poster Session

December 7, 2024

5:50 – 6:45 pm

Highlights of data from Daiichi Sankyo’s DXd ADC portfolio at SABCS 2024 include:

Presentation Title

Author

Abstract

Presentation (CST)

ENHERTU (trastuzumab deruxtecan; T-DXd)

HER2 Low & HER2 Ultralow Breast Cancer

Efficacy and safety of trastuzumab deruxtecan (T-DXd) vs physician’s choice of chemotherapy by pace of disease progression on prior endocrine-based therapy: an additional analysis from DESTINY-Breast06

A Bardia

LB1-04

Oral Session

Tuesday, December 10

6:00 – 7:00 pm

Trastuzumab deruxtecan in combination with capecitabine or capivasertib in patients with HER2 low metastatic breast cancer: a phase 1b, multicenter, open-label study (DESTINY-Breast08)

K. Jhaveri

P3-09-17

Poster Session

Thursday, December 12

12:30 – 2:00 pm

A real-world study of the effectiveness and safety of trastuzumab deruxtecan in HER2 low metastatic breast cancer among racial and ethnic minorities and older populations in the United States

M. Henderson

P2-12-20

Poster Session

Wednesday, December 11

5:30 – 7:00 pm

Agreement between the DESTINY-Breast04/06 VENTANA 4B5 HER2 IHC clinical trial assay and other comparator assays for HER2 low breast cancer: overall results of a large-scale, multicenter global ring study

G. Viale

P1-03-28

Poster Session

Wednesday, December 11

12:30 – 2:00 pm

Trastuzumab deruxtecan in HER2 low metastatic breast cancer patients with newly diagnosed or progressing brain metastases: the TUXEDO-4 phase II trial

M. Marhold

P3-08-21

Poster Session

Thursday, December 12

12:30 – 2:00 pm

Re-evaluation of human epidermal growth factor receptor 2 (HER2) immunohistochemistry (IHC) 0 or 1+ in metastatic breast cancer samples to characterize the proportion of HER2 ultralow (IHC 0 with membrane staining)

S. Krishnamurthy

P3-09-20

Poster Session

Thursday, December 12

12:30 – 2:00 pm

Valemetostat and trastuzumab deruxtecan in patients with HER2 low, previously treated, unresectable or metastatic breast cancer

S. Tolaney

P3-08-24

Poster Session

Thursday, December 12

12:30 – 2:00 pm

Phase 1b study of EZH1/2 inhibitor valemetostat in combination with trastuzumab deruxtecan in subjects with HER2 low/ultra-low/null metastatic breast cancer

T. Iwase

P3-12-28

Poster Session

Thursday, December 12

12:30 – 02:00 pm

HER2 Positive Breast Cancer

Exploratory biomarker analysis of trastuzumab deruxtecan vs trastuzumab emtansine efficacy in human epidermal growth factor receptor 2-positive metastatic breast cancer in DESTINY-Breast03

W. Jacot

PS8-03

Spotlight Poster Session

Thursday, December 12

7:00 – 8:30 am

Effects of trastuzumab deruxtecan (T-DXd) on health-related quality of life and neurological function in patients with HER2+ advanced/metastatic breast cancer with or without brain metastases: DESTINY-Breast12 results

N. Harbeck

PS14-10

Spotlight Poster Session

Friday, December 13

7:00 – 8:30 am

Real-world analysis of interstitial lung disease in patients with HER2-positive unresectable or recurrent breast cancer treated with trastuzumab deruxtecan: all-patient post-marketing surveillance study in Japan

J. Tsurutani

P1-02-10

Poster Session

Wednesday, December 11

12:30 – 2:00 pm

HER2 Expressing Breast Cancer

Trastuzumab deruxtecan with pembrolizumab in previously treated HER2 expressing advanced or metastatic breast cancer: interim analyses of the breast cohorts from the open-label, multicenter, phase 1b study DS8201-A-U106

H. Rugo

P5-07-29

Poster Session

Friday, December 13

12:30 – 2:00 pm

Patritumab Deruxtecan (HER3-DXd)

HR Positive, HER2 Negative Breast Cancer

Primary results of SOLTI VALENTINE: neoadjuvant randomized phase II trial of HER3-DXd alone or in combination with letrozole for high-risk hormone receptor positive/HER2-negative early breast cancer

M. Oliveira

LBA1-06

Oral Presentation

Tuesday, December 10

6:00 – 7:00 pm

ICARUS-BREAST02: safety, tolerability, and anti-tumor activity of patritumab deruxtecan (HER3-DXd) monotherapy and combinations in patients with inoperable advanced breast cancer following progression on trastuzumab deruxtecan (T-DXd)

B. Pistilli

P2-08-27

Poster Presentation

Wednesday, December 11

5:30 – 7:00 pm

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

Presentation Title

Author

Abstract

Presentation (PST)

VANFLYTA (quizartinib)

FTL3 -ITD Positive AML

Correlation of baseline gene mutations with quizartinib efficacy in patients with FLT3-ITD positive newly diagnosed acute myeloid leukemia in the phase 3 QuANTUM-First trial

M. Levis

848

Oral Presentation

Monday, December 9

3:00 – 3:15 pm

QuANTUM-First: effects of quizartinib on RFS, OS, CIR, and MRD in newly diagnosed patients with FMS-like tyrosine kinase 3-internal tandem duplication positive (FLT3-ITD+) acute myeloid leukemia who received continuation therapy

M. Levis

2890

Poster Presentation

Sunday, December 8

6:00 – 8:00 pm

QuANTUM-First: deep-dive analysis of FMS-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD) detection methods utilized for enrollment and longitudinal MRD detection in newly diagnosed patients with FLT3-ITD+ acute myeloid leukemia

J. Rohrbach

4278

Poster Session

Monday, December 9

6:00 – 8:00 pm

Anchored matching adjusted indirect treatment comparison of quizartinib vs midostaurin in newly diagnosed patients with FLT3-ITD positive acute myeloid leukemia

S. Unni

1509

Poster Session

Saturday, December 7

5:30 – 7:30 pm

FLT3-ITD Negative AML

Trial in progress: the phase 3, randomized, double-blind, placebo-controlled QuANTUM-Wild study of quizartinib in combination with chemotherapy and as single-agent maintenance in newly diagnosed FLT3-ITD negative acute myeloid leukemia

P. Montesinos

1504.3

Poster Session

Saturday, December 7

5:30 – 7:30 pm

Final results of QUIWI: a double blinded, randomized PETHEMA trial comparing standard chemotherapy plus quizartinib versus placebo in adult patients with newly diagnosed FLT3-ITD negative AML

P. Montesinos

1512

Poster Session

Saturday, December 7

5:30 – 7:30 pm

Enhanced validation of the FLT3-like gene expression signature as a predictive biomarker for quizartinib response in FLT3-ITD negative acute myeloid leukemia: expanded cohort and extended follow-up from the PETHEMA QUIWI trial

A.

Mosquera

Orgueira

1552

Poster Session

Saturday, December 7

5:30 – 7:30 pm

Correlation of ELN-risk and gene mutations with quizartinib efficacy in patients with FLT3-ITD negative newly diagnosed acute myeloid leukemia in the phase 2 QUIWI PETHEMA trial

R. Rodriguez- Viega

2895

Poster Session

Sunday, December 8

6:00 – 8:00 pm

Valemetostat (EZHARMIA in Japan only)

B-Cell & T-Cell

Lymphomas

Valemetostat monotherapy in patients with relapsed or refractory large B-cell lymphoma: primary results of the phase 2 VALYM study from the LYSA

E. Bachy

4479

Poster Session

Monday, December 9

6:00 – 8:00 pm

Prediction of clinical response by phased variants in circulating tumor DNA (ctDNA) in the VALENTINE-PTCL01 trial of patients with relapsed or refractory peripheral T-cell lymphoma

N. Mehta-Shah

4342

Poster Session

Monday, December 9

6:00 – 8:00 pm

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 & Co., Inc, Rahway, NJ, USA. 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 pyrrolobenzodiazepine (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 December 2, 2024 Omeros Corporation (Nasdaq: OMER) reported that two abstracts directed to zaltenibart (OMS906), Omeros’ investigational inhibitor of MASP-3, the key activator of the alternative pathway of complement, will be presented at the 66th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), to be held December 7-10, 2024 in San Diego (Press release, Omeros, DEC 2, 2024, View Source [SID1234648739]). The zaltenibart abstracts are directed to the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare, life-threatening hematological disorder. Enrollment for the zaltenibart Phase 3 clinical trials in PNH is expected to open in early 2025.

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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Both abstracts are available on the ASH (Free ASH Whitepaper) website at www.hematology.org. Details of the congress presentations and direct links to the abstracts are found below.

Monotherapy Treatment with Zaltenibart (OMS906), an Alternative Pathway Masp-3 Inhibitor, Improved Key Hematologic Parameters in Patients with PNH with a Suboptimal Response to Ravulizumab: Interim Results from a Phase 2 Proof-of-Concept Study
Abstract Number / Link: 4072
Session: 508. Bone Marrow Failure: Acquired: Poster III
Presentation Time: Monday, December 9, 2024, 6:00 PM-8:00 PM
Location: San Diego Convention Center, Halls G-H
Presenting Author: Morag Griffin, MBChB, MRCP

Population Pharmacokinetics/Pharmacodynamics and Clinical Pharmacology of Zaltenibart (OMS906) in Healthy Subjects and Patients with PNH
Abstract Number / Link: 4081
Session: 508. Bone Marrow Failure: Acquired: Poster III
Presentation Time: Monday, December 9, 2024, 6:00 PM-8:00 PM
Location: San Diego Convention Center, Halls G-H
Presenting Author: William Pullman, BMedSc, MBBS, PhD, FRACP

The presentation materials associated with each abstract will be made available on Omeros’ website at www.omeros.com following the congress presentations.

About OMS906

OMS906 is an investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-3 (MASP-3), the key and most proximal activator of the complement system’s alternative pathway. The complement system is a critical part of innate immunity and plays a central role in host homeostasis and defense against pathogens. Responsible for the conversion of pro-complement factor D to complement factor D, MASP-3 is believed to be the premier target in the alternative pathway – it has the lowest native circulating level and low relative clearance compared to the other alternative pathway proteins and, unlike C5 and C3 blockers, MASP-3 inhibition leaves intact the lytic arm of the classical pathway, important for fighting infection. Also, unlike other components of the alternative pathway, MASP-3 is believed not to be an acute phase reactant, which could provide a significant advantage to MASP-3 inhibitors, like OMS906, over other alternative pathway inhibitors. MASP-3 inhibitors are thought to have preventive or therapeutic effects across a broad range of diseases including paroxysmal nocturnal hemoglobinuria (PNH), hemolytic uremic syndrome (HUS), atypical HUS, traumatic brain injury, arthritis, geographic atrophy or "dry" macular degeneration, ischemia-reperfusion injury, transplant-related complications and other immune-related disorders.

On December 2, 2024 Mission Bio, a leader in single-cell multiomics solutions for precision medicine, reported a collaboration with Dr. C. Ola Landgren, MD, PhD, head of one of the world’s leading myeloma computational and translational research laboratories (Press release, Mission Bio, DEC 2, 2024, View Source [SID1234648738]). Dr. Landgren’s team, including Dr. David Coffey and Dr. Benjamin Diamond, at the University of Miami’s Sylvester Comprehensive Cancer Center, will work together to generate clinical data sets using Mission Bio’s Tapestri Single-cell DNA Multiple Myeloma Panel to examine Multiple Myeloma (MM) at an unprecedented level of clonal detail, promising to reveal new insights that may potentially improve outcomes for MM patients.

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MM is a challenging and incurable blood cancer that afflicts around 230,000 people worldwide. Relapse is a particular problem for many of these patients — as many as 50% experience relapse within the first year of frontline treatments, and only 20% of relapse victims survive for five years with current standard therapies.

The key to controlling relapse in MM patients lies in better understanding of resistant clones: cells that have developed mutations or alterations that help them evade treatment. However, current tools inadequately profile the disease from the initial emergence of clones to full-blown myeloma. Using clinical samples from University of Miami, the goal of the collaboration is to help predict which patients are at higher risk of relapse, and, in the event of relapse, whether it can inform and guide subsequent treatment decisions. In addition, the project will determine if blood can be used as an alternative sample for patient testing instead of bone marrow samples. The utilization of blood would vastly improve sample accessibility and alleviate the invasive patient experience.

"We recognize that Multiple Myeloma is a genetically complex disease that hasn’t been easy to comprehend fully using existing methods, particularly when it comes to the crucial questions of when patients might experience relapse and what clinicians should do next when relapse occurs," said Dr. Landgren. "Our aim is to utilize Tapestri to better understand Multiple Myeloma disease heterogeneity, which in turn will allow us to detect and treat relapse faster. Ultimately, we hope to demonstrate the clinical feasibility of the Multiple Myeloma assay and to facilitate the establishment of Tapestri to advance outcomes for patients."

"Our partners and customers continue to push the boundaries of single-cell DNA and multiomic analysis in new and inspiring ways," said Brian Kim, CEO of Mission Bio. "The work being done by Dr. Landgren and his team promises to unearth critical insights that will not only be able to help predict relapse in Multiple Myeloma patients, but also inform more effective, personalized treatment strategies in the future."