MedPath

Patritumab

Generic Name
Patritumab
Drug Type
Biotech
CAS Number
1262787-83-6
Unique Ingredient Identifier
86780VJI1Q
Background

Patritumab has been used in trials studying the treatment of LUNG CANCER, Solid Tumors, Neoplasms by Site, Head and Neck Neoplasms, and Non-small Cell Lung Cancer, among others.

Merck and Daiichi Sankyo Launch Phase 3 Trial of Novel B7-H3 Targeted ADC for Advanced Esophageal Cancer

• The IDeate-Esophageal01 Phase 3 trial has begun evaluating ifinatamab deruxtecan, a potential first-in-class B7-H3 directed antibody-drug conjugate, against standard chemotherapy in advanced esophageal squamous cell carcinoma. • Esophageal squamous cell carcinoma accounts for 90% of global esophageal cancers with dismal survival rates of 15-20%, highlighting the urgent need for new treatment approaches after first-line therapy failure. • The trial follows promising early-phase results and will enroll approximately 510 patients across Asia, Europe, and North America, with overall survival as the primary endpoint.

Tarlatamab Shows Superior Survival in Small Cell Lung Cancer: Key Highlights from ASCO 2025

• Amgen's tarlatamab (Imdelltra) demonstrated superior overall survival compared to standard chemotherapy in relapsed small cell lung cancer patients, potentially establishing a new second-line treatment standard. • The phase 3 IMforte trial revealed that lurbinectedin plus atezolizumab significantly improved survival as maintenance therapy for extensive-stage SCLC following induction chemoimmunotherapy. • Neoadjuvant nivolumab plus chemotherapy showed statistically significant overall survival improvement in resectable NSCLC patients in the CheckMate 816 trial, reinforcing its role in perioperative treatment.

SystImmune to Present Promising Data on Iza-bren for HER2-Negative Breast Cancer at ESMO Breast 2025

• SystImmune will present updated safety and efficacy data for izalontamab brengitecan (iza-bren), an EGFRxHER3 bispecific antibody-drug conjugate, in locally advanced or metastatic breast cancer at ESMO Breast 2025 on May 16. • Early clinical results show encouraging efficacy across all HER2 levels in HER2-negative breast cancer patients, including HER2 0 patients, suggesting potential therapeutic benefits for patients with limited treatment options. • Iza-bren, being jointly developed by SystImmune and Bristol Myers Squibb, works by blocking EGFR and HER3 signals to cancer cells while delivering a therapeutic payload that induces cancer cell death.

Robust Pipeline of 200+ Therapies Targets Colorectal Cancer Treatment Landscape

• DelveInsight's latest report reveals a robust pipeline with over 195 companies developing 200+ therapies for colorectal cancer, highlighting significant innovation in targeted treatments and immunotherapies. • Key drug candidates include XL092 (Exelixis), Adagrasib (Mirati Therapeutics), Olaparib (Merck/AstraZeneca), and novel approaches like LYL845, an autologous tumor-infiltrating lymphocyte therapy from Lyell Immunopharma. • The metastatic colorectal cancer segment shows particular promise with 150+ companies advancing 180+ pipeline therapies, including innovative treatments targeting specific mutations and immune pathways.

Akeso Completes Patient Enrollment in Phase III Trial Comparing Ivonescimab for First-Line Squamous NSCLC Treatment

• Akeso has completed enrollment for the HARMONi-6 Phase III trial comparing ivonescimab plus chemotherapy to tislelizumab plus chemotherapy for first-line squamous non-small cell lung cancer treatment. • Ivonescimab, a novel PD-1/VEGF bispecific antibody, is currently being evaluated in six Phase III lung cancer trials globally, with potential applications across multiple cancer types. • The drug addresses a significant unmet need among 520,000 annual cases of advanced sq-NSCLC patients, offering a promising alternative for those ineligible for current anti-angiogenesis treatments.

ADCs Reshape NSCLC Treatment Landscape: Key Trials Show Promise and Challenges

Recent clinical trials demonstrate the evolving role of antibody-drug conjugates (ADCs) in non-small cell lung cancer treatment. Notable results from TROPION-Lung01 trial showed modest PFS improvement with datopotamab deruxtecan compared to docetaxel, while studies like HERTHENA-Lung01 and DESTINY-Lung02 explore targeted approaches for specific mutations.

Datopotamab Deruxtecan's Role in HR+/HER2- Breast Cancer Treatment: Sequencing and Safety Considerations

• Datopotamab deruxtecan (Dato-DXd) is poised to become a standard treatment for metastatic hormone receptor-positive, HER2-negative breast cancer after prior systemic therapy. • Optimal sequencing of antibody-drug conjugates (ADCs) like Dato-DXd, sacituzumab govitecan, and trastuzumab deruxtecan remains uncertain, especially considering overlapping toxicities. • Real-world toxicity profiles suggest sacituzumab govitecan may cause more cytopenias and diarrhea, while Dato-DXd and trastuzumab deruxtecan are linked to interstitial lung disease. • The lack of overall survival difference in the TROPION-Breast01 trial raises questions about efficacy issues or the impact of crossover between treatment arms.

Experts Highlight Advances in Lung Cancer Treatment: Immunotherapy, ADCs, and Equity in Care

• Leading oncologists at the Chicago IVBM event discussed the transformation of lung cancer treatment, emphasizing the evolution of immunotherapy from second-line to first-line and early-stage treatments. • Experts addressed emerging technologies including antibody-drug conjugates like trastuzumab deruxtecan, highlighting significant progression-free survival benefits in second-line settings. • The panel identified critical challenges in healthcare equity, calling for standardized molecular testing protocols and enhanced collaboration between academic centers and community providers.

Advancements in Breast Cancer Research Unveiled at SABCS 2024

• The PATINA trial suggests palbociclib with anti-HER2 and endocrine therapy may become a new standard for HR+, HER2+ metastatic breast cancer. • COMET trial indicates active monitoring is comparable to surgery for low-risk DCIS, offering a potential alternative management option. • OlympiA trial's long-term results reinforce olaparib's role in preventing recurrence and highlight the importance of BRCA testing for early-stage breast cancer.

FDA Issues Complete Response Letter for Subcutaneous Amivantamab in EGFR-Mutated NSCLC

• The FDA issued a Complete Response Letter (CRL) for subcutaneous amivantamab (Rybrevant) for EGFR-mutated non-small cell lung cancer (NSCLC). • The CRL was due to observations during a standard pre-approval inspection of a manufacturing facility and not related to efficacy or safety data. • The rejection does not impact the currently approved intravenous (IV) formulation of amivantamab, which remains available to patients. • Johnson & Johnson is working with the FDA to resolve the issues and bring the subcutaneous formulation to patients as quickly as possible.

Patritumab Deruxtecan Shows Efficacy in High-Risk HR+/HER2- Breast Cancer

• Patritumab deruxtecan, with or without letrozole, shows comparable efficacy to multiagent chemotherapy in high-risk, HR+/HER2- breast cancer patients. • The phase 2 SOLTI VALENTINE trial demonstrated similar pathologic complete response (pCR) and objective response rate (ORR) with the antibody-drug conjugate. • Treatment with patritumab deruxtecan resulted in fewer grade 3 or higher treatment-related adverse events compared to standard chemotherapy. • The study supports the potential incorporation of patritumab deruxtecan in treating high-risk HR-positive/HER2-negative early breast cancer.

DATROWAY® (Datopotamab Deruxtecan) Receives EU Approval for Previously Treated Metastatic HR+/HER2- Breast Cancer

• DATROWAY, a TROP2-directed antibody drug conjugate (ADC), has been approved in the European Union for treating adult patients with unresectable or metastatic HR+/HER2- breast cancer who have received endocrine therapy and at least one line of chemotherapy. • The approval is based on the TROPION-Breast01 phase 3 trial, which showed DATROWAY reduced the risk of disease progression or death by 37% compared to chemotherapy, with a median PFS of 6.9 months versus 4.9 months. • This marks the second ADC approved for breast cancer based on Daiichi Sankyo's DXd technology and the third medicine from their oncology pipeline to receive EU approval, highlighting their commitment to developing innovative cancer treatments.

FDA Wraps Up 2024 with Key Approvals for Drugs Targeting Various Conditions

• The FDA approved Vertex's Alyftrek for cystic fibrosis, offering improved dosing and potential market exclusivity. • Novo Nordisk's Alhemo was approved for hemophilia A and B, providing a new option for patients with inhibitors. • Bristol Myers Squibb's Opdivo Qvantig gained approval as a subcutaneous formulation, offering faster administration for various solid tumors. • Eli Lilly's Zepbound secured approval for obstructive sleep apnea in obese adults, marking the first prescription medicine for this condition.

Datopotamab Deruxtecan Granted FDA Breakthrough Therapy Designation for EGFR-Mutated NSCLC

• The FDA granted Breakthrough Therapy Designation to datopotamab deruxtecan (Dato-DXd) for EGFR-mutated non-small cell lung cancer (NSCLC). • The designation is based on Phase 2 TROPION-Lung05 data, indicating a potential benefit in previously treated patients. • Datopotamab deruxtecan is a TROP2-directed antibody-drug conjugate being jointly developed by AstraZeneca and Daiichi Sankyo. • AstraZeneca and Daiichi Sankyo withdrew their BLA for Dato-DXd in advanced or metastatic nonsquamous NSCLC based on Phase 3 data from the TROPION-Lung01 trial.

Trastuzumab Deruxtecan's Expanding Role in HER2-Expressing Solid Tumors

• Trastuzumab deruxtecan (T-DXd) received FDA approval for HER2-positive solid tumors, marking a significant expansion beyond breast, lung, gastric, and colorectal cancers. • Clinical trials like DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02 demonstrated T-DXd's efficacy across various tumor types, especially those with high HER2 expression. • T-DXd treatment requires careful monitoring due to potential adverse events like interstitial lung disease (ILD), necessitating proactive management strategies. • The DEBBRAH trial showed promising antitumor activity of T-DXd in HER2+ and HER2-low advanced breast cancer patients with leptomeningeal disease (LMD), warranting further investigation.

Enhertu Wins 2024 Prix Galien USA Award for Best Biotechnology Product

• Enhertu, developed by Daiichi Sankyo and AstraZeneca, received the 2024 Prix Galien USA Award for Best Biotechnology Product, recognizing its impact on improving human health. • The award acknowledges Enhertu's innovative HER2-directed antibody-drug conjugate (ADC) technology and its role in redefining metastatic breast cancer treatment. • Enhertu has received multiple approvals globally for HER2-positive and HER2-low breast cancer, NSCLC with HER2 mutations, and HER2-positive gastric or GEJ adenocarcinoma. • Ongoing clinical trials are evaluating Enhertu's efficacy and safety across various HER2-targetable cancers, both as monotherapy and in combination with other treatments.

Cobenfy: A Novel Schizophrenia Treatment Approved by FDA

• The FDA approved Cobenfy (xanomeline and trospium chloride) as a first-in-class treatment for schizophrenia, offering a new mechanism of action. • Cobenfy targets cholinergic receptors, unlike traditional dopamine receptor-targeting drugs, potentially reducing adverse side effects. • Clinical trials demonstrated significant improvements in schizophrenia symptoms with Cobenfy, including positive, negative, and cognitive aspects. • While promising, further research is needed to assess long-term tolerability and comparative effectiveness, with cost being a consideration.

FDA Approves New Therapies from Lilly, Novartis, Merck, J&J, and AstraZeneca

• Eli Lilly's Ebglyss secured FDA approval for treating moderate-to-severe atopic dermatitis in adults and children, offering significant skin clearance and itch relief. • Novartis' Kisqali gained approval for adjuvant treatment of early breast cancer, reducing recurrence risk by 28.5% when combined with an aromatase inhibitor. • Merck's Keytruda, combined with chemotherapy, received FDA approval for first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma (MPM). • J&J's Rybrevant was approved for expanded use in advanced non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions after EGFR TKI treatment.

ESMO 2024: Key Breast Cancer Advances Highlighted

• Final KEYNOTE-522 data confirmed pembrolizumab's benefit in neoadjuvant chemotherapy for early-stage triple-negative breast cancer, improving 5-year overall survival. • NATALEE trial's 4-year update showed ribociclib plus aromatase inhibition significantly improved invasive disease-free survival in high-risk, hormone receptor-positive early breast cancer. • DESTINY-Breast12 trial demonstrated trastuzumab deruxtecan's significant intracranial activity in HER2-positive metastatic breast cancer patients with brain metastases. • ICARUS-BREAST01 trial revealed promising objective response rates and progression-free survival with patritumab deruxtecan in HER3-positive, hormone receptor-positive, HER2-negative metastatic breast cancer.

Pembrolizumab Approved for Mesothelioma; Patritumab Deruxtecan Shows Promise in NSCLC

• FDA has expanded the approval of pembrolizumab (Keytruda) in combination with pemetrexed and cisplatin for previously untreated advanced/metastatic malignant pleural mesothelioma. • Patritumab deruxtecan demonstrated a statistically significant improvement in progression-free survival versus doublet chemotherapy in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer. • A novel three-drug regimen yielded an 80% response rate in a small study of patients with advanced chronic myelogenous leukemia or high-risk acute myeloid leukemia.
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