On December 4, 2023 PharmaMar (MSE:PHM) reported that its licensing partner, Luye Pharma Group Ltd, has received marketing approval for Zepzelca (lurbinectedin) by the Pharmaceutical Administration Bureau in Macao for the treatment of adult patients with metastatic Small-Cell Lung Cancer (SCLC), with disease progression on or after platinum-based chemotherapy (Press release, PharmaMar, DEC 4, 2023, View Source [SID1234638114]).

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The approval of lurbinectedin in Macao is mainly based on data from two clinical trials. One based on the data from the open-label, multi-center, single-arm monotherapy clinical trial in 105 adult patients with relapsed SCLC (including patients with platinum-sensitive and platinum-resistant disease), that the Food and Drug Administration (FDA) used to grant accelerated approval for lurbinectedin. The other, conducted in China, was a single-arm, dose-escalation, and dose-expansion clinical trial aiming to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of lurbinectedin in Chinese patients with advanced tumors, including relapsed SCLC.

In April 2019, PharmaMar and Luye Pharma signed an agreement for the development and commercialization of lurbinectedin in SCLC.

Lurbinectedin is now approved in 14 countries around the world plus Macao. In the meantime, lurbinectedin Marketing Authorisation applications are under review for approval in Hong Kong and mainland China.

Lung cancer is the most common of all cancers in China in terms of incidence and mortality. In 2020, there were about 815,000 new cases of lung cancer and 714,000 deaths[1] caused by it, of which SCLC accounted for 13-17%[2].

On December 4, 2023 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), reported that the Korean Ministry of Food and Drug Safety (MFDS) have approved the clinical trial to test narmafotinib (AMP945) in combination with gemcitabine and Abraxane, in advanced pancreatic cancer patients in Korea (Press release, Amplia Therapeutics, DEC 4, 2023, View Source [SID1234638106]).

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This approval means that the five preselected clinical trial sites in Korea can be opened shortly to commence enrolment of patients. Six sites in Australia were opened in November and experience at these sites with the initial 1B Phase of the ACCENT trial will help optimise the recruitment and management of patients in this important Phase 2 stage of the trial both in Australia and Korea.

Amplia’s CEO and Managing Director Dr Chris Burns commented: "The approval from the Korean MFDS comes after many months of hard work from the Amplia team, who have worked closely with the Korean regulators, to achieve this important approval. The Korean health system and their clinical trial capability is world class, and recruitment into pancreatic cancer trials has been historically strong. We look forward to opening our planned sites in Korea and working with the excellent clinical groups, to further test the impact of our drug narmafotinib in the treatment of advanced pancreatic cancer."

About the ACCENT Trial

The protocol for the ACCENT trial is entitled ‘A Phase 1b/2a, Multicentre, Open Label Study of the Pharmacokinetics, Safety and Efficacy of AMP945 in Combination with Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients’.

The trial is a single-arm open label study conducted in two stages. The Phase 1b stage of the trial, now complete, determined an optimal dose of AMP945 when dosed in combination with gemcitabine and Abraxane, in first-line patients with advanced pancreatic cancer.

The Phase 2a, second stage of the trial, is designed to assess efficacy of the triple drug combination of narmafotinib, gemcitabine and Abraxane. The primary endpoint is Objective Response Rate (ORR) with secondary endpoints including Progression Free Survival (PFS) and Overall Survival (OS). Safety and tolerability will continue to be assessed.

More information about the ACCENT trial, including a list of participating sites, can be found via our website and at ClinicalTrials.gov under the identifier NCT05355298. The Company will provide further updates as recruitment proceeds.

On December 3, 2023 Carmot Therapeutics Inc. (Carmot), a clinical-stage biotechnology company dedicated to developing life-changing therapeutics for people living with metabolic diseases including obesity and diabetes, reported that it has entered into a definitive merger agreement for Roche to acquire Carmot at a purchase price of $2.7 billion upfront and the potential for $400 million in milestone payments (Press release, Carmot, DEC 3, 2023, View Source [SID1234638120]).

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"We are proud of the pipeline that we have built in obesity and diabetes and the strong data we have generated to date," said Heather Turner, JD, Chief Executive Officer of Carmot. "With distinct routes of administration and the potential for combinations, we feel Carmot’s pipeline has the potential to meet patients where they are in their metabolic journey and have a significant impact on patients’ lives. We are confident that Roche will enable robust development of our programs and help us achieve our goal of delivering life-changing therapeutics for people living with metabolic and potentially other diseases."

Carmot’s clinical pipeline includes subcutaneous and oral incretins with best-in-class potential to treat obesity in patients with and without diabetes. CT-388 is a weekly injectable, Phase 2 ready, dual GLP-1/GIP receptor agonist for the treatment of obesity in patients with and without type 2 diabetes. CT-996, currently in Phase 1, is a once-daily oral, small molecule GLP-1 receptor agonist intended to treat patients with obesity and type 2 diabetes. CT-868 is a Phase 2, once-daily subcutaneous injectable, dual GLP-1/GIP receptor agonist intended for the treatment of type 1 diabetes patients with overweight or obesity. Carmot also has preclinical programs in development for the treatment of metabolic diseases.

"The obesity epidemic is a worldwide crisis and only continues to worsen. By 2035 it is estimated that nearly half the world’s population will be overweight or obese1," said Tim Kutzkey, PhD, Chair of Carmot’s Board of Directors. "A health problem of this magnitude requires significant commitment and resources to address, and we believe that patients will be best served with Carmot’s pipeline backed by the drug development expertise, extensive resources and worldwide reach of Roche."

Terms of the Agreement

Under the terms of the agreement, Roche will pay Carmot’s equity holders $2.7 billion in cash at the closing of the transaction. Additionally, Carmot’s equity holders are entitled to receive payments of up to $400 million on the achievement of certain milestones. Carmot and its employees will join the Roche Group as part of Roche’s Pharmaceuticals Division.

The transaction is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary closing conditions. The closing of the transaction is expected to take place in the first quarter of 2024.

Centerview Partners LLC and J.P. Morgan Securities LLC are acting as financial advisors and Cooley LLP is acting as legal counsel for Carmot.

On December 3, 2023 Ideaya Biosciences, Inc., a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported agenda topics for its Investor R&D Day (Press release, Ideaya Biosciences, DEC 3, 2023, View Source [SID1234638107]). The webcast event will be hosted by IDEAYA on Monday, December 4, 2023 at 8:00 am to 9:30 am ET.

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The presentations by IDEAYA management and key opinion leaders will showcase scientific insights and clinical development opportunities across IDEAYA’s synthetic lethality pipeline, including IDE397 (MAT2A) in Phase 2, IDE161 (PARG) in Phase 1, GSK101/IDE705 (Pol Theta Helicase) in Phase 1, and the Werner Helicase program for which an IND submission is planned for 2024. In addition, IDEAYA will highlight its next generation initiatives for MTAP-deletion, that include a wholly-owned program where a development candidate nomination is targeted in 2024 and multiple first-in-class clinical combination opportunities. The IDEAYA Investor R&D Day Webcast agenda will be the following:

Agenda Topics

The Synthetic Lethality Paradigm
­ IDEAYA Vision, Strategy and Pipeline (Yujiro S. Hata, CEO)
Computational Drug Discovery
­ Overview of Current Approaches at IDEAYA (Mike White, CSO)
IDE161 Clinical Data and Program Updates (Timothy Yap, MD Anderson)
Emerging Therapeutic Opportunities for MTAP-deletion
­ IDEAYA’s Multiple-Pronged Strategy (Mike White, CSO; Darrin Beaupre, CMO)
IDEAYA and GSK Partnership
­ Pol Theta Helicase and Werner Helicase Programs (Ramon Kemp, GSK)
Key Opinion Leader Presenters

Timothy Yap, M.D., Associate Professor, Department for Investigational Cancer Therapeutics and Department of Thoracic/Head and Neck Medical Oncology, Medical Director, Institute for Applied Cancer Science, Associate Director of Translational Research, Institute for Personalized Cancer Therapy, M.D. Anderson Cancer Center
Ramon Kemp, Ph.D., Vice President, Head, Oncology EDL, Interim Head, Oncology MDL, GSK
Investor R&D Day Webcast Presentation and Registration Information

IDEAYA’s Investor R&D Day webcast presentation will be available on the company’s website, at its Investor Relations portal (View Source) in advance of the investor webcast presentation at approximately 6:00 am ET.

Registration is available at View Sourceevents or View Source

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.