On December 2, 2023 Merus N.V. (Nasdaq: MRUS) ("Merus", "the Company", "we", or "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported updated interim clinical data on MCLA-129 from ongoing expansion cohorts in non-small cell lung cancer (NSCLC) and in previously treated head and neck squamous cell carcinoma (HNSCC) were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia Congress 2023 (Press release, Merus, DEC 2, 2023, View Source [SID1234638113]).

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"MCLA-129 is a very active drug in EGFRm NSCLC and we’re planning a focused investment to evaluate MCLA-129 in combination with chemotherapy, which we expect to start early in 2024," said Bill Lundberg M.D., President, Chief Executive Officer of Merus. "We are in a fortunate position to have a strong balance sheet. We also recognize the importance of being responsible with our resources to maintain financial strength, as we plan to initiate a phase 3 trial of petosemtamab in 2L+ HNSCC by mid-2024."

The reported data are from three expansion cohorts in the open label trial evaluating MCLA-129 in combination with osimertinib, a third generation EGFR TKI, in treatment-naïve EGFR mutant (m) NSCLC (1L) and in EGFRm NSCLC that has progressed on osimertinib (2L+), as well as MCLA-129 monotherapy in previously treated HNSCC.

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

Observations in the presentation include:

As of an August 10, 2023 data cutoff date, 60 patients (pts) with advanced/metastatic EGFRm NSCLC were treated (16/1L, 44/2L+)
In the 1L setting, 16 pts were treated, with all pts evaluable for response
All 16 pts experienced tumor shrinkage
9 confirmed partial responses (PRs) and 3 unconfirmed PRs were observed (12/16, 75%; 95% CI 48-93) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. per investigator assessment; 11 responses were ongoing, including the 3 unconfirmed PRs
94% disease control rate (DCR) (95% CI 70-100)
5.1 months (range 0.5-8.5) median duration of exposure with 81% continuing treatment
In the 2L+ setting, 44 pts were treated, with 34 pts evaluable for response
All received prior osimertinib in the 1L/2L setting, 50% as only prior therapy; 36% received prior chemotherapy
11 confirmed PRs and 1 unconfirmed PR were observed (12/34, 35%; 95% CI 20-54) by RECIST v1.1. per investigator assessment, 9 responses were ongoing as of the data cutoff date, including the 1 unconfirmed PR
74% DCR (95% CI 56-87)
2.8 months (range: 0.3-11.5) median duration of exposure with 39% continuing treatment
Early safety assessment in 60 NSCLC pts treated with MCLA-129 plus osimertinib included
Most common adverse events (AEs) regardless of causality were infusion related reactions (IRRs; composite term) in 87% (12% ≥ grade(G) 3)
Treatment emergent adverse events (TEAEs) led to discontinuations in 14 (23%) pts
Treatment related interstitial lung disease (ILD)/pneumonitis in 13 pts (22%), four were G1, two were G2, four were G3, and three were G5
Venous thromboembolic (VTE) events in 23%; 5% treatment related
Efficacy and safety of MCLA-129, an anti-EGFR/c-MET bispecific antibody, in head and neck squamous cell cancer (HNSCC) 

Observations in the presentation include:

As of an August 10, 2023 data cutoff date, 22 pts with previously treated HNSCC were treated
20 pts were evaluable for response
Pts received a median of 3 lines of prior therapy, 22% prior chemotherapy, 20% prior anti-PD-(L) 1, 36% prior cetuximab
1 confirmed and 1 unconfirmed PR were observed (2/20, 10%, 95% CI 1–32) by RECIST v1.1. per investigator assessment
The confirmed response was ongoing with a duration of response of 3.4+ months at data cutoff date
The unconfirmed PR was confirmed after the data cutoff date with treatment still ongoing at the time of presentation
60% DCR (95% CI 36–81)
2.2 months (range 0.5–6) median duration of exposure
Early safety assessment in 22 HNSCC pts treated with MCLA-129 monotherapy included
IRRs (composite term) in 73% (14% ≥ G3) all on cycle 1 day 1
Skin toxicity (composite term) in 86% (14% ≥ G3)
No ILD or VTE events were reported
No G5 TEAEs were reported

The full presentations are available on the Publications page of our website.

On December 1, 2023 Xspray Pharma reported the outcome of exercised warrants of series TO5, issued in connection with the rights issue in June this year and for which the subscription period ended on November 30, 2023 (Press release, Xspray, DEC 1, 2023, View Source [SID1234649579]). In total, 2,307,242 series TO5-warrants were exercised to subscribe for new shares. Xspray Pharma thereby receives proceeds of SEK 92.3 million which will be used for the US launch of the company’s first product, Dasynoc, as well as for continued development of other product candidates in the company’s portfolio.

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"I’m pleased that we once again secure a high subscription rate in a challenging market. The outcome is evidence that not only our institutional and other major shareholders as well as key individuals in management participated, but also that a large number of smaller investors decided to subscribe. Our shareholders have once again demonstrated their strong support for our commercialization plan which we now can pursue with undeterred force," comments Per Andersson, CEO of Xspray Pharma.

In connection to the rights issue completed in June 2023, 3,132,946 warrants of series TO5 were issued. Each TO5 gave the right to subscribe for a newly issued share for SEK 40 during the period 16 – 30 November 2023. When the subscription period had ended 2,307,242 warrants had been used to subscribe for shares at SEK 40 each. The number of shares in the company thereby increases by 2,307,242 and the share capital increases by SEK 2,307,242.

"We feel confident in continuing on our chosen path, strengthened by the knowledge that we now have necessary funds to successfully finance our operations until launch. The budgeted cost ahead of the launch has also been reduced, partly by determining the launch date and partly by the fact that we no longer need to allocate funds for a legal dispute," comments Per Andersson.

The proceeds raised by the exercise of warrants of series TO5 will primarily be used to fund pre-launch activities for Dasynoc on the US market as well as general operation purposes, ongoing operational costs and continued development of product candidates.

On December 1, 2023 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that it will participate in one upcoming investor conference in December (Press release, Allogene, DEC 1, 2023, View Source [SID1234638088]).

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The JMP Securities Hematology and Oncology Summit
Wednesday, December 6, 2023
8:30AM PT/11:30AM ET

Any available webcasts will be posted to the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following a live webcast, a replay will be available on the Company’s website for approximately 30 days.

On December 1, 2023 Daiichi Sankyo (TSE: 4568) reported that it will present new clinical research across its oncology portfolio in multiple types of solid and blood cancers at the 2023 ESMO (Free ESMO Whitepaper) Asia Congress (#ESMOAsia23), San Antonio Breast Cancer Symposium (#SABCS23) and American Society of Hematology (ASH) (Free ASH Whitepaper) (#ASH23) Annual Meeting prior to its annual R&D Day (Press release, Daiichi Sankyo, DEC 1, 2023, https://www.businesswire.com/news/home/20231130031289/en/Daiichi-Sankyo-Demonstrates-Breadth-and-Depth-of-Oncology-Portfolio-Across-Multiple-Cancers-with-New-Data-at-ESMO-Asia-SABCS-and-ASH [SID1234638102]).

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Presentation highlights include the first presentation of results from three trials from Daiichi Sankyo’s DXd ADC and hematology portfolio, which include the DESTINY-Gastric06 phase 2 trial of ENHERTU (trastuzumab deruxtecan) in Chinese patients with previously treated HER2 positive locally advanced/metastatic gastric cancer or gastroesophageal junction adenocarcinoma at ESMO (Free ESMO Whitepaper) Asia, the DESTINY-Breast08 phase 1b trial of ENHERTU in combination with anastrozole or fulvestrant in patients with HER2 low metastatic breast cancer at SABCS and the VALENTINE-PTCL01 phase 2 trial of valemetostat in patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) at ASH (Free ASH Whitepaper).

"Our goal is to push the boundaries of science to change the way cancer is treated," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "These data reinforce the breadth and depth of our oncology pipeline and the important progress we are making in developing innovative medicines and exploring combination strategies for patients across a wide range of cancers, including breast, lung, gastric, acute myeloid leukemia and peripheral T-cell lymphoma."

Subgroup analyses of the TROPION-Lung05 phase 2 trial of datopotamab deruxtecan (Dato-DXd) in Asian patients with non-small cell lung cancer (NSCLC) with actionable genomic alterations and the DESTINY-Lung02 phase 2 trial of ENHERTU in Asian patients with HER2 mutant NSCLC will be presented at ESMO (Free ESMO Whitepaper) Asia. Additional subgroup analyses of the QuANTUM-First phase 3 trial in patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML), which formed the basis of recent approvals of VANFLYTA (quizartinib) in the EU, Japan and U.S. will be presented at ASH (Free ASH Whitepaper).

Daiichi Sankyo will hold its annual R&D Day for investors, analysts and media on Monday, December 11 at 5:30 – 7:00 pm EST/Tuesday, December 12 at 7:30 – 9:00 am JST. Company executives will provide highlights of Daiichi Sankyo’s research data presented at SABCS and ASH (Free ASH Whitepaper), as well as updates on the company’s R&D strategy.

ESMO Asia Data
Encore presentations of the TROPION-Lung01 phase 3 trial and TROPION-Lung05 phase 2 trial of datopotamab deruxtecan (Dato-DXd) as well as the DESTINY-PanTumor02 phase 2 trial of ENHERTU will be presented at ESMO (Free ESMO Whitepaper) Asia from December 1 – 3 in Singapore, along with other data, including:

Presentation Title

Presenter

Abstract

Presentation

ENHERTU (trastuzumab deruxtecan; T-DXd)

Lung

Trastuzumab deruxtecan (T-DXd) in Asian patients with human epidermal growth factor receptor 2 (HER2; ERBB2) mutant (HER2m) metastatic non–small cell lung cancer: subgroup analysis of DESTINY-Lung02

Y. Goto

510MO

Mini-Oral Session
December 2, 2023
9:00 – 10:30 am SGT

Pan
Tumor

Trastuzumab deruxtecan (T-DXd) for pretreated patients with HER2 expressing solid tumors: primary analysis from the DESTINY-PanTumor02 study

D. Oh

74MO

Mini-Oral Session
December 1, 2023
10:45 am – 12 :15 pm SGT

Gastric

Trastuzumab deruxtecan (T-DXd) in Chinese patients with previously treated HER2 positive locally advanced/ metastatic gastric cancer or gastroesophageal junction adenocarcinoma: primary efficacy and safety from the phase 2 single-arm DESTINY-Gastric06 trial

L. Shen

172P

Poster Presentation
December 2, 2023

Datopotamab deruxtecan (Dato-DXd)

Lung

Datopotamab deruxtecan (Dato-DXd) vs docetaxel in previously treated advanced/metastatic non-small cell lung cancer: results of the randomized phase 3 study TROPION-Lung01

M. Ahn

509MO

Mini-Oral Session
December 2, 2023
9:00 – 10:30 SGT

TROPION-Lung05: datopotamab deruxtecan (Dato-DXd) in previously treated non-small cell lung cancer with actionable genomic alterations

S. Kitazono

518MO

Mini-Oral Session
Sunday, December 3
9:00 – 10:30 am SGT

TROPION-Lung05: datopotamab deruxtecan (Dato-DXd) in Asian patients with previously treated non-small cell lung cancer with actionable genomic alterations

Y. Goto

552P

Poster Presentation
December 2, 2023

SABCS Data
Highlights of Daiichi Sankyo data across several subtypes of breast cancer to be presented at SABCS from December 5 – 9 in San Antonio, Texas, include:

Presentation Title

Author

Abstract

Presentation

ENHERTU (trastuzumab deruxtecan; T-DXd)

HER2 Low
Breast

Trastuzumab deruxtecan (T-DXd) in combination with anastrozole or fulvestrant in patients with HER2 low HR+ advanced/metastatic breast cancer: a phase 1b, open-label, multicenter, dose-expansion study (DESTINY-Breast08)

K. Jhaveri

RF02-03

Rapid-Fire Mini-Oral
December 7, 2023
12:00 – 12:45 pm CST

An open-label, interventional multicenter study of trastuzumab deruxtecan monotherapy in patients with unresectable and/or metastatic HER2 low or HER2 immunohistochemistry 0 breast cancer: DESTINY-Breast15

S. Modi

PO2-19-06

Poster Presentation
December 6, 2023
5:00 – 7:00 pm CST

HER2 Positive
Breast

European real-world experience of patients with HER2+ advanced/metastatic breast cancer accessing trastuzumab deruxtecan through a named patient program: first interim analysis of EUROPA T-DXd

M. De Laurentiis

PO3-16-12

Poster Presentation
December 7, 2023
12:00 – 2:00 pm CST

Real-world experience with trastuzumab deruxtecan in patients with breast cancer: 6 month interim analysis of an all patient post marketing surveillance in Japan

J. Tsurutani

PO3-17-07

Poster Presentation
December 7, 2023
12:00 – 2:00 pm CST

Population pharmacokinetics of trastuzumab deruxtecan (T-DXd) in HER2 positive breast cancer subjects: analyses across 12 Phase 1-3 studies

C. Li

PO3-04-01

Poster Presentation
December 7, 2023
12:00 – 2:00 pm CST

Exposure-efficacy and exposure-safety analysis of trastuzumab deruxtecan in patients with advanced metastatic HER2+ breast cancer: analyses from phase 3 studies DESTINY-Breast02 and DESTINY-Breast03

C. Li

PO3-04-02

Poster Presentation
December 7, 2023
12:00 – 2:00 pm CST

Datopotamab deruxtecan (Dato-DXd)

HR Positive
Breast

Randomized phase 3 study of datopotamab deruxtecan vs chemotherapy for patients with previously treated inoperable or metastatic hormone receptor positive, HER2 negative breast cancer: results from TROPION-Breast01

A. Bardia

GS02-01

Oral Presentation
December 7, 2023
8:15 – 8:30 am CST

TNBC

Durvalumab + datopotamab deruxtecan in patients with PD-L1 positive advanced/metastatic triple negative breast cancer: arm 8 of the phase 1b/2, open label, platform BEGONIA study

P. Schmid

PO1-19-10

Poster Presentation
December 6, 2023
12:00 – 2:00 pm CST

ASH Data
Highlights of Daiichi Sankyo data from its hematology portfolio to be presented at ASH (Free ASH Whitepaper) from December 9 – 12 in San Diego, California, include:

Presentation Title

Presenter

Abstract

Presentation

Valemetostat (EZHARMIA in Japan only)

T-cell
Lymphoma

Efficacy and safety of valemetostat monotherapy in patients with relapsed or refractory peripheral T-cell lymphomas: primary results of the phase 2 VALENTINE-PTCL01 study

S. Horwitz

302

Oral Presentation
December 9, 2023
4:15 pm PST

Valemetostat for relapsed or refractory peripheral T- cell lymphomas: primary results from a phase 1 trial

E. Jacobsen

303

Oral Presentation
December 9, 2023
4:30 pm PST

B-cell
Lymphoma

Valemetostat for relapsed or refractory B-cell lymphomas: primary results from a phase 1 trial

K. Izutsu

1731

Poster Presentation
December 9, 2023
5:30 – 7:30 pm PST

VANFLYTA (quizartinib)

FLT3-ITD
AML

QuANTUM-First: FMS-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD)-specific measurable residual disease (MRD) clearance assessed through induction and consolidation is associated with improved overall survival in newly diagnosed FLT3-ITD+ AML patients

A. Perl

832

Oral Presentation
December 11, 2023
3:30 pm PST

QuANTUM-First: safety by treatment phase and by age in newly diagnosed patients with FMS-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD) positive acute myeloid leukemia (AML)

H. Erba

972

Oral Presentation
December 11, 2023
5:45 pm PST

Patient-reported outcomes in acute myeloid leukemia patients with FLT3-ITD mutation receiving quizartinib vs. standard chemotherapy: results from the QuANTUM-First trial

E. Oliva

918

Oral Presentation
December 11, 2023
4:00 pm PST

QuANTUM-First: clinical bridging study for FMS-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD) companion diagnostic development

J. Rohrbach

4260

Poster Presentation
December 11, 2023
6:00 – 8:00 pm PST

Kinetics of complete remission (CR) and CR duration and its impact on overall survival (OS) and event-free survival (EFS) in QuANTUM-First

P. Montesinos

4254

Poster Presentation
December 11, 2023
6:00 – 8:00 pm PST

About the DXd ADC Portfolio of Daiichi Sankyo
The DXd ADC portfolio of Daiichi Sankyo currently consists of six ADCs in clinical development across multiple types of cancer. ENHERTU, a HER2 directed ADC, and datopotamab deruxtecan (Dato-DXd), a TROP2 directed ADC, 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. U.S.A. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo.

Designed using Daiichi Sankyo’s proprietary DXd ADC technology to target and deliver a cytotoxic payload inside cancer cells that express a specific cell surface antigen, 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.

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

On December 1, 2023 Strata Oncology, Inc. ("Strata"), a next-generation precision oncology company enabling smarter cancer treatment, reported that it will present new data in scientific posters at the 2023 North America Conference on Lung Cancer (NACLC) taking place December 1-3, 2023 in Chicago, Illinois and the San Antonio Breast Cancer Symposium (SABCS) taking place December 5-9, 2023 in San Antonio, Texas (Press release, Strata Oncology, DEC 1, 2023, View Source [SID1234638101]).

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The data to be presented includes results for innovative, proprietary predictive biomarkers for response to anti-PD-1/PD-L1 immunotherapy and antibody-drug conjugates (ADCs) — the Immunotherapy Response Score (IRS) and ADC Treatment Response Score (ADC TRS), respectively. Strata has developed these biomarkers and others using data collected through an observational clinical trial protocol called the Strata Trial (NCT03061305). All of these biomarkers take advantage of the company’s unique molecular profiling platform that combines DNA and quantitative RNA sequencing on a single small tumor tissue sample.

"Many of the most exciting recent advances in cancer treatment – such as immunotherapy and antibody-drug conjugates – do not currently have biomarkers that can accurately predict response. Strata has taken on this challenge by advancing multivariate predictive treatment selection algorithms that capture the complex biology required for a tumor response," said Scott Tomlins, M.D., Ph.D., Strata Oncology co-founder and chief medical officer. "We believe that this type of strategy is required to fully realize the potential of precision oncology to improve patient outcomes. We look forward to sharing our latest advances at NACLC and SABCS."

Poster presentation details are below. Both posters will be available on the Strata Oncology website following the presentation.

North America Conference on Lung Cancer (NACLC)

Poster Title: Validation of Immunotherapy Response Score (IRS) for Predicting Pembrolizumab Monotherapy Benefit in First Line (1L) Non-small cell lung cancer (NSCLC)

Session Date and Time: Saturday, December 2, 5:40-6:55 PM CST

San Antonio Breast Cancer Symposium (SABCS)

Poster Title: A Multivariate Biomarker to Guide Antibody-Drug Conjugate Selection and Provide Insight on Response Differences Across Breast Cancer Subtypes

Session Date and Time: Wednesday, December 6, 12:00-2:00 PM CST