On September 17, 2024 Merck reported that the HERTHENA-Lung02 phase 3 trial evaluating patritumab deruxtecan in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who received prior EGFR tyrosine kinase inhibitor (TKI) treatment met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement versus platinum plus pemetrexed induction chemotherapy followed by pemetrexed maintenance chemotherapy (Press release, Merck & Co, SEP 17, 2024, View Source [SID1234646705]). Overall survival (OS) data were immature at the time of the analysis and the trial will continue to further assess OS, a secondary endpoint.

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Patritumab deruxtecan is a specifically engineered potential first-in-class HER3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed by Daiichi Sankyo and Merck (NYSE: MRK), known as MSD outside of the United States and Canada.

NSCLC accounts for approximately 85% of all lung cancers worldwide with up to 70% of NSCLC cases diagnosed at an advanced stage and EGFR-activating mutations occur in 14% to 38% of all NSCLC tumors worldwide.1,2,3 Following initial treatment for metastatic EGFR-mutated NSCLC with an EGFR TKI, many patients experience disease progression and currently available therapies in the second-line setting are limited, highlighting the need for new approaches to improve outcomes.3,4

Data from the HERTHENA-Lung02 trial will be presented at an upcoming medical meeting and shared with global regulatory authorities.

"These results from HERTHENA-Lung02 demonstrate the potential of patritumab deruxtecan to become an important treatment option for certain patients with EGFR-mutated non-small cell lung cancer with prior tyrosine kinase inhibitor treatment," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "We plan to share these findings with regulatory authorities to discuss next steps."

"We are encouraged by these results demonstrating a statistically significant progression-free survival improvement compared to platinum plus pemetrexed induction chemotherapy followed by pemetrexed maintenance chemotherapy in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer who received prior tyrosine kinase inhibitor treatment," said Marjorie Green, MD, Senior Vice President and Head of Oncology, Global Clinical Development, Merck. "Together with Daiichi Sankyo, we are committed to helping patients with previously treated EGFR-mutated non-small cell lung cancer, where there is a high unmet need."

The safety profile seen in HERTHENA-Lung02 was consistent with that observed for patritumab deruxtecan in previous lung cancer clinical trials with no new safety signals identified. The majority of interstitial lung disease (ILD) events were low grade (grade 1 and 2). There were two grade 5 ILD events observed.

About HERTHENA-Lung02

HERTHENA-Lung02 is a global, multicenter, open-label, phase 3 trial evaluating the efficacy and safety of patritumab deruxtecan (5.6 mg/kg every three weeks) versus four cycles of pemetrexed and platinum chemotherapy in patients with metastatic or locally advanced NSCLC with an EGFR-activating mutation (exon 19 deletion or L858R) after failure of third-generation (e.g., osimertinib, lazertinib, aumolertinib, alflutinib) EGFR TKI therapy. Patients in the comparator arm without disease progression after four cycles of pemetrexed and platinum chemotherapy are able to continue treatment with maintenance pemetrexed with no restriction on the number of cycles.

The primary endpoint of HERTHENA-Lung02 was PFS as assessed by blinded independent central review (BICR). Secondary endpoints included OS, objective response rate, duration of response, clinical benefit rate, time to response, disease control rate, and safety. Patients enrolled in the study underwent brain imaging to allow for assessment of intracranial endpoints, including intracranial PFS as assessed by BICR.

HERTHENA-Lung02 enrolled 586 patients in Asia, Europe, North America and Oceania. For more information about the trial, visit ClinicalTrials.gov.

About EGFR-Mutated Non-Small Cell Lung Cancer

Nearly 2.5 million lung cancer cases were diagnosed globally in 2022.5 Lung cancer is the most common cancer and the leading cause of cancer-related deaths worldwide.5 Approximately 85% of lung cancer is classified as NSCLC with EGFR-activating mutations occurring in 14 to 38% of all NSCLC tumors worldwide.1,3 NSCLC is diagnosed at an advanced stage in up to 70% of patients and often has a poor prognosis with worsening outcomes after each line of subsequent therapy.2,6

Following initial treatment for metastatic EGFR-mutated NSCLC with an EGFR TKI, many patients experience disease progression and currently available therapies in the second-line setting are limited, highlighting the need for new approaches to improve outcomes.3,4

About HER3

HER3 is a member of the HER family of receptor tyrosine kinases.7 It is estimated that about 83% of primary NSCLC tumors and 90% of advanced EGFR-mutated tumors express HER3 after prior EGFR TKI treatment.8 HER3 is associated with poor treatment outcomes, including shorter relapse-free survival and significantly reduced survival.9,10 There is currently no HER3 directed therapy approved for the treatment of any cancer.

About Patritumab Deruxtecan

Patritumab deruxtecan (HER3-DXd) is an investigational HER3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, patritumab deruxtecan is composed of a fully human anti-HER3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Patritumab deruxtecan is currently being evaluated as both a monotherapy and in combination with other therapies in a global development program, which includes HERTHENA-Lung02, a phase 3 trial evaluating the efficacy and safety of patritumab deruxtecan versus pemetrexed plus platinum chemotherapy in patients with EGFR-mutated locally advanced or metastatic NSCLC following disease progression on or after treatment with a third-generation EGFR TKI; HERTHENA-Lung01, a phase 2 trial in metastatic or locally advanced NSCLC with an activating EGFR mutation previously treated with at least one EGFR TKI and one platinum-based chemotherapy-containing regimen; HERTHENA-PanTumor01, a phase 2 trial in 10 locally advanced or metastatic solid tumor types, including melanoma, gastric and head and neck cancer, among other types of cancer, previously treated with at least one prior systemic therapy; a phase 1 trial in combination with osimertinib in EGFR-mutated locally advanced or metastatic NSCLC; and a phase 1 trial in previously treated patients with advanced NSCLC. A phase 1/2 trial in HER3 expressing metastatic breast cancer also has been completed.

On September 17, 2024 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 the acceptance of an abstract on petosemtamab, a Biclonics targeting EGFR and LGR5, in previously treated (2L+) patients with recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC) for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia Congress 2024 taking place in Singapore December 6-8, 2024 (Press release, Merus, SEP 17, 2024, View Source [SID1234646706]).

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Rapid oral presentation:
Title: Petosemtamab (MCLA-158) monotherapy in previously treated (2L+) recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC): Phase 2 trial
Abstract #: 411MO
Session Title: Mini Oral session: Head and Neck cancers
Session Date and Time: December 7, 2024; 3:25-3:30 p.m. SGT
Location Hall: 404

The abstract will be available on the ESMO (Free ESMO Whitepaper) Asia Congress website on Sunday, Dec. 1, 2024 at 11:05 a.m. ET. The full presentation will be available on the Merus website at the start of each session.

Merus provided an interim clinical update on petosemtamab monotherapy in 2L+ HNSCC at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, demonstrating a 37% response rate among 43 evaluable patients. The presentation at ESMO (Free ESMO Whitepaper) Asia will include updated efficacy, durability and safety data from that initial 2L+ HNSCC cohort along with interim data from the dose optimization cohort evaluating petosemtamab monotherapy 1500 or 1100 mg dose levels in 2L+ HNSCC.

Merus has confirmed through feedback with the U.S. Food and Drug Administration (FDA) that petosemtamab 1500 mg every two weeks is appropriate for further development in HNSCC as monotherapy, and in combination with pembrolizumab.

Merus is currently enrolling LiGeR-HN2, a phase 3 trial evaluating the efficacy and safety of petosemtamab compared to investigator’s choice of single agent chemotherapy or cetuximab in previously treated (2/3L) patients with r/m HNSCC and plans to initiate LiGeR-HN1, a phase 3 trial evaluating petosemtamab in combination with pembrolizumab in frontline (1L) HNSCC by year end 2024.

About Petosemtamab
Petosemtamab, or MCLA-158, is a bispecific Biclonics low-fucose human full-length IgG1 antibody targeting the epidermal growth factor receptor (EGFR) and the leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5). Petosemtamab is designed to exhibit three independent mechanisms of action including inhibition of EGFR-dependent signaling, LGR5 binding leading to EGFR internalization and degradation in cancer cells, and enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) activity.

About LiGeR-HN2
LiGeR-HN2, a phase 3 trial, will evaluate the safety and efficacy of petosemtamab compared to investigator’s choice of methotrexate, docetaxel, or cetuximab in 2/3L r/m HNSCC patients. The trial is open to adult patients that have progressed on or after anti-PD-1 therapy and platinum-containing therapy. The primary endpoints are overall response rate as assessed by BICR based on RECIST v1.1 and overall survival. Secondary endpoints are duration of response and progression free survival. Merus plans to enroll approximately 500 patients in the trial.

On September 17, 2024 Immutep reported new data from EFTISARC-NEO, a Phase II investigator-initiated trial of eftilagimod alpha (efti) in combination with radiotherapy plus KEYTRUDA (pembrolizumab) for patients with soft tissue sarcoma (STS), will be presented at the Connective Tissue Oncology Society (CTOS) 2024 Annual Meeting taking place 13-16 November 2024, in San Diego, California (Press release, Immutep, SEP 17, 2024, View Source [SID1234646707]).

Results from triple combination of efti, radiotherapy and KEYTRUDA (pembrolizumab) to be presented at the Connective Tissue Oncology Society 2024 Annual Meeting
EFTISARC-NEO is the first trial to evaluate efti in a neoadjuvant (prior to surgery) setting
Soft tissue sarcoma is a hard-to-treat orphan disease with poor prognosis & high unmet medical need

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Presentation Details
Title: Preliminary Results from a Phase 2 EFTISARC-NEO Trial of Neoadjuvant Soluble LAG-3 Protein Eftilagimod Alpha, Pembrolizumab, and Concurrent Radiotherapy in Patients with Resectable Soft Tissue Sarcoma
Presenter: Pawel Sobczuk, M.D., Ph.D., Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland
Date: Thursday, 14 November 2024
Format: Poster Presentation

EFTISARC-NEO is the first to evaluate efti in a neoadjuvant setting, which importantly provides access to tumour tissue before and after treatment to assess efti’s impact on the tumour microenvironment. Initial efficacy data from this novel triple combination reported in May 2024 showed very encouraging results in the first six patients with the majority having deep responses rarely seen in STS patients with standard therapeutic approaches.

STS is an orphan disease with high unmet medical need and a poor prognosis for patients. The incidence of STS varies in different regions across Europe, with ~23,400 cases annually according to the RARECARE project. In the United States, the number of new STS cases in 2024 is estimated to be ~13,590 with ~5,200 deaths, according to the American Cancer Society.

The open-label EFTISARC-NEO Phase II study will treat up to 40 patients and is being conducted by the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw. The trial is primarily funded with an approved grant from the Polish government awarded by the Polish Medical Research Agency program. For more information, visit clinicaltrials.gov (NCT06128863).

Immutep will announce the data to the ASX and make the poster presentation available on the Posters & Publications section of Immutep’s website, after the presentation at CTOS 2024.

On September 17, 2024 Senhwa Biosciences, Inc. (TPEx: 6492), , a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, reported that an Investigational New Drug (IND) application for Pidnarulex has been submitted to the U.S. FDA by the NCI. Senhwa’ investigational drug, Pidnarulex (CX-5461), has been selected as an experimental drug in the NExT (NCI Experimental Therapeutics) cancer program, sponsored by the Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), for a five-year period (Press release, Senhwa Biosciences, SEP 17, 2024, View Source [SID1234646709]). This drug will be used in a pharmacodynamic (PD) pilot study involving patients with advanced solid tumors.

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In addition to this monotherapy trial, NCI is considering to plan future clinical trials for Pidnarulex (CX-5461) in combination with other therapies, including immunotherapy, antibody-drug conjugates (ADC), and PARP inhibitors (Poly ADP-ribose Polymerase inhibitors, PARPi). Should these trials be realized, they will be led by the NCI, leveraging its medical team, scientific talent network, and regulatory resources—capabilities that most biotech companies would struggle to accomplish independently. This support from the NCI is hoped to significantly accelerate the development and expansion of indications for Pidnarulex (CX-5461), ultimately benefiting patients with an earlier market launch.

This clinical trial, for which the IND application has been submitted by NCI’s Division of Cancer Treatment and Diagnosis (DCTD), aims to explore the response of various biomarkers to Pidnarulex (CX-5461) in patients with or without homologous recombination deficiency (HRD).

Pidnarulex (CX-5461), developed by Senhwa, is a first-in-class small-molecule designed to stabilize G-quadruplex (G4) structures, which are frequently observed in promoters of oncogenes. By stalling replication fork progression, Pidnarulex induces DNA damage and promotes cancer cell death. Through this mechanism, Pidnarulex holds great potential as a therapeutic agent for various cancers.

In recent years, immunotherapy has become the fastest-growing category in the cancer drug market, while the development of antibody-drug conjugates (ADC) is undoubtedly an important trend in biopharmaceuticals. Major pharmaceutical companies, including Pfizer, AbbVie, AstraZeneca, and Merck, have invested billions of dollars in acquiring or licensing related technologies. According to a recent report from market research firm Evaluate, the ADC market is expected to reach $30 billion by 2028, while the global cancer immunotherapy market will surpass a staggering $224 billion by 2030. Given that only about 20% to 25% of patients are effectively treated with immunotherapy, combining immunotherapy with targeted drugs is becoming increasingly important in cancer treatment. Combination therapies can address multiple treatment pathways within the complex tumor microenvironment and may enhance the efficacy of immunotherapy, making it a hot research area for major pharmaceutical companies. Therefore, Senhwa is confident and optimistic about the NCI’s plans to advance clinical trials of Pidnarulex (CX-5461) in combination with immunotherapy and ADCs.

On September 17, 2024 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, reported that clinical data of IBI354 (HER2 monoclonal antibody-camptothecin derivative conjugate) in advanced solid tumors was presented at the 2024 ESMO (Free ESMO Whitepaper) Congress (ClinicalTrials.gov, NCT05636215) (Press release, Innovent Biologics, SEP 17, 2024, View Source [SID1234646710]).

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The data presented is from a Phase 1/2 study aimed at evaluating the safety, tolerability, and preliminary efficacy of IBI354 in participants with advanced solid tumors. A total of 368 participants with advanced solid tumors were enrolled and received different doses of IBI354 monotherapy, including 178 with breast cancer, 92 with ovarian cancer, 38 with colorectal cancer, and 60 with other tumors. Among them, 42.7% of the participants had previously undergone five or more systemic treatment regimens.

IBI354 monotherapy demonstrated excellent safety profile.

The dosage was escalated to 18mg, with no DLT events observed.
The most common treatment-related adverse events (TRAEs) were nausea, decreased white blood cell count and anemia. The incidence of interstitial lung disease (ILD) was only 1.6%, all of which were grade 1.
Overall, 21.5% of patients experienced TRAEs ≥ grade 3, 2.4% experienced TRAEs leading to dose reduction and 1.6% experienced TRAEs leading to discontinuation, with no TRAEs leading to death.
IBI354 monotherapy showed promising efficacy signals in multiple tumor types.

In platinum-resistant ovarian cancer cohort (n=87, treated at 6~12mg/kg IBI354), the overall objective response rate (ORR) was 40.2% and the disease control rate (DCR) was 81.6%. In the 12mg/kg subgroup (n=40), the ORR reached 52.5% and the DCR was 90.0%. In participants with HER2 1+ (n=27), the ORR reached 55.6% and the DCR was 88.9%. As of the data cutoff date, the median follow-up time was 6.5 months, and both progression-free survival (PFS) and duration of response (DoR) had not yet matured.
In HER2-positive breast cancer cohort (n= 59, treated at 6~15mg/kg IBI354), the ORR and DCR were 67.8% and 88.1%, respectively.
In HER2-low breast cancer cohort (n=67, treated at 6~15mg/kg IBI354), the ORR and DCR were 41.8% and 82.1%, respectively. In the 12mg/kg subgroup (n=26), the ORR and DCR were 61.5% and 88.5%, respectively.
In HER2-positive gastrointestinal malignancies cohort (n=35, treated at 6~15mg/kg IBI354), the ORR and the DCR were 57.1% and 91.4%, respectively. 26 participants were diagnosed with colorectal cancer, of which 14 achieved an objective response (1 subject with HER2 IHC2+ FISH+ achieved a confirmed objective response), resulting in an ORR and DCR of 53.8% and 92.3%, respectively. As of press date, another participant with HER2 low expression (IHC2+ FISH-) colorectal cancer achieved a confirmed objective response.
Professor Qi Zhou, Chief Physician at the Gynecologic Oncology Center of Chongqing University Affiliated Cancer Hospital and the Principal Investigator of the gynecologic oncology cohort study, stated, "Approximately 70% of ovarian cancer patients experience relapse within 3 years following surgery and platinum-based adjuvant therapy, eventually developing platinum resistance after multiple recurrences[1]. These patients have limited effective treatment options. Current evidence indicates that non-platinum single-agent chemotherapy or the addition of anti-angiogenic therapy results in an ORR of just 4-13.2% and a median OS of merely 10.9-14 months[2]-[3][4][5][6]. As a fully-validated target, HER2-targeted therapy has proven effective in breast and gastric cancers. IBI354, an anti-HER2 monoclonal antibody-camptothecin derivative conjugate, has shown good anti-tumor activity in platinum-resistant ovarian cancer with HER2 expression of 1+. In our Phase 1 study, the ORR was 67.5%, DCR was 88.9%, and median rate is 39.0% at the 12mg/kg Q3W dose level, while maintaining a favorable safety profile. Extending the PFS and OS remains a critical clinical challenge in platinum-resistant recurrent ovarian cancer. The development of antibody-drug conjugates for the treatment of resistant recurrent cancers has become a hot spot, and promising results have been observed. The clinical efficacy of antibody-drug conjugates targeting HER2 low expression warrants further clinical research and exploration, which could benefit more patients with platinum-resistant ovarian cancer."

Doctor Daphne Day from the Medical Oncology Department at Monash Health in Melbourne, Australia, stated: "Breast cancer is the second most commonly diagnosed cancer globally, the most common cancer in women, and a cause of cancer-related deaths. HER2 amplification or overexpression has been proven to play a significant role in the occurrence and progression of breast cancer, underscoring the importance of HER2-directed therapy. IBI354, as an anti-HER2 monoclonal antibody-camptothecin derivative conjugate, has shown promising preliminary results, with meaningful objective response and disease control rates in HER2-positive and -low breast cancer. Additionally, IBI354 has demonstrated excellent clinical safety and tolerability. Existing clinical data suggest that IBI354 has substantial development potential in the breast cancer population."

Professor Lin Shen from Peking University Cancer Hospital, stated, "Colorectal cancer (CRC) has become the second most common malignant tumor in China, and its incidence and mortality rates are still rising annually[7]. The HER2-targeted therapy plays an important role in the later-line treatment of CRC. Preliminary results suggest that IBI354, an anti-HER2 monoclonal antibody-camptothecin derivative conjugate, has shown positive efficacy in HER2-positive gastrointestinal malignancies. Notably, IBI354 has also demonstrated antitumor effects in HER2-low CRC populations, where HER2-targeted therapies are relatively less effective. IBI354 has exhibited good clinical safety and tolerability in later-line CRC patients, supporting further exploration and development in this population."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "With the rapid advancements in ADC drugs for oncology treatment, Innovent is strategically positioning itself in the ADC field. At this year’s ESMO (Free ESMO Whitepaper) conference, we are showcasing, for the first time, the safety and efficacy data of IBI354 across various advanced solid tumors, fully demonstrating Innovent’s platform capabilities in ADC drug development. We will continue to invest in research and development of ADC innovative molecules, with the aim of providing patients more and better treatment options."

About IBI354 (Anti-HER2 Antibody-Camptothecin Derivative Conjugate)

IBI354 is an innovative HER2-targeted antibody–drug conjugate developed using Innovent’s proprietary novel topoisomerase inhibitor NT3 platform. With a drug-to-antibody ratio (DAR) of 8, IBI354 delivers a high payload of effective drugs to tumors. The highly hydrophilic linker design contributes to its excellent biophysical and pharmacokinetic (PK) properties, while the hydrophobic payload enhances its bystander effect, targeting adjacent antigen-low or negative tumor cells. IBI354 exhibits extremely low exposure of free toxin in circulation and has an ideal safety profile based on pre-clinical and clinical studies. IBI354 has demonstrated remarkable anti-tumor activity in various tumor-bearing mice models, particularly in those resistant to HER2-targeted therapies and in metastatic tumors. Innovent Biologics is conducting clinical research in China, the United States, and Australia to assess the efficacy and safety of IBI354 for treating various advanced malignancies. Additionally, multiple new ADC molecules from Innovent’s NT3 platform are under clinical development and have shown promising safety and efficacy signals.