MK-6302 (pegfilgrastim biosimilar) / Merck (MSD) - LARVOL DELTA

ctDNA Assessment of EGFR Mutation Status in Chinese Patients with Advanced Non–Small-Cell Lung Cancer in Read World Setting (WCLC 2017) - P=N/A; "Using plasma samples to detect EGFR mutation is feasible. ctDNA based EGFR mutation test could be a surrogate when tissue biopsy is not available due to limited tissue availability and procedural feasibility."

Biomarker • Clinical • Real-world evidence • Non Small Cell Lung Cancer

Final Results of a Phase 2 Study of the hsp90 Inhibitor Luminespib (AUY922) in NSCLC Patients Harboring EGFR Exon 20 Insertions (WCLC 2017) - P2; "The study met its primary endpoint and suggests that luminespib may be an active therapy for advanced NSCLC patients with EGFR ins20. Luminespib is generally well-tolerated, though reversible low-grade ocular toxicity is common. Further study of luminespib and other Hsp90 inhibitors in this population is warranted, as are novel systems to continue drug supply for benefitting patients when availability of experimental compounds is limited."

Clinical • P2 data • Non Small Cell Lung Cancer

[VIRTUAL] ECOG-ACRIN 5162: A phase II study of osimertinib 160 mg in NSCLC with EGFR exon 20 insertions. (ASCO 2020) - P2 | "Osimertinib 160mg daily is well-tolerated and showed clinical activity in EGFR ins20-mutant NSCLC with a response rate of 25%, disease control rate of 85%, and mPFS of 9.7 months. The adverse events with osimertinib 160 mg QD in this cohort were consistent with other reports of this regimen; grade 3 rash and diarrhea were not observed. Research Funding: U.S. National Institutes of Health"

P2 data • Brain Cancer • Fatigue • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • Thoracic Cancer • EGFR

Activity of afatinib in patients (pts) with NSCLC harboring uncommon EGFR mutations: Pooled analysis of three large phase IIIB trials (ESMO Asia 2019) - P=N/A, P3; "Background: In the registrational trials, afatinib (afa) was active against NSCLC tumors harboring common and uncommon EGFR mutations, including G719X, L861Q and S768I,1 and is approved in this setting. In this ‘real-world’ analysis, nearly 20% of pts with EGFRm+ NSCLC harbored uncommon EGFR mutations. Afa was active in a broad range of these pts, including some with Ins20 mutations.Legal entity responsible for the study: Boehringer Ingelheim. Funding: Boehringer Ingelheim."

P3 data • Retrospective data • Brain Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • EGFR • Exon 20

[VIRTUAL] Afatinib in Asian and non-Asian patients (pts) with EGFR mutation positive (EGFRm+) NSCLC harboring major uncommon mutations (ESMO Asia 2020) - "Uncommon mutations were classed as: de novo T790M; exon 20 insertions (Ins20); major uncommon mutations (G719X/L861Q/S768I); compound mutations (≥2 uncommon mutations); and other uncommon mutations. Legal entity responsible for the study: Boehringer Ingelheim. Funding: Boehringer Ingelheim."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

[VIRTUAL] Afatinib in Asian and nonAsian patients (pts) with EGFR mutation positive (EGFRm+) NSCLC harboring major uncommon mutations (ESMO Asia 2020) - "Uncommon mutations were classed as: de novo T790M; exon 20 insertions (Ins20); major uncommon mutations (G719X/L861Q/S768I); compound mutations (≥2 uncommon mutations); and other uncommon mutations. Yang JC, et al. Lancet Oncol 2015;16:830‒8 Boehringer Ingelheim."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

[VIRTUAL] Afatinib in Asian and nonAsian patients (pts) with EGFR mutation positive (EGFRm+) NSCLC harboring major uncommon mutations (ESMO Asia 2020) - "Uncommon mutations were classed as: de novo T790M; exon 20 insertions (Ins20); major uncommon mutations (G719X/L861Q/S768I); compound mutations (≥2 uncommon mutations); and other uncommon mutations. Yang JC, et al. Lancet Oncol 2015;16:830‒8 Boehringer Ingelheim."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

[VIRTUAL] Afatinib in Asian and Non-Asian Patients (pts) with EGFR Mutation-Positive (EGFRm+) NSCLC Harboring Major Uncommon Mutations (IASLC-NACLC 2020) - "Afatinib is effective in pts with NSCLC with major uncommon and compound EGFR mutations, with broad activity against other uncommon EGFR mutations and some Ins20 mutations, unaffected by ethnicity. Asian pts appeared to have a high proportion of major uncommon mutations, known to be highly sensitive to afatinib."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Frequency of Uncommon EGFR Mutations in NSCLC in an Argentinean University Institution (WCLC 2016) - "Seven patients (50%) received EGFR-TKIs for first or second line treatment (4 erlotinib, 2 afatinib and 1 gefitinib). Although the clinical characteristics of our cohort are similar to the data published, we noted a higher and unusual frequency of EGFR uncommon mutations especially exon 18 G719X.All cases treated with EGFR-TKIs showed poor sensitivity to therapy. Time to treatment and accessibility to appropriate therapy in this subgroup are important issues to explore in future reports from public institutions of our region."

Biomarker • Retrospective data • Biosimilar • Non Small Cell Lung Cancer • Oncology

Clinical Activity of Afatinib in Patients With Non-Small-Cell Lung Cancer Harboring Uncommon EGFR Mutations: A Spanish Retrospective Multicenter Study. (PubMed, Clin Lung Cancer) - "In clinical practice, afatinib was active in patients with u-EGFRm NSCLC, particularly in complex and single mutations. Further strategies are needed for patients with ins20, a subgroup u-EGFRm with a lower clinical benefit with afatinib."

Journal • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • EGFR

Dr. Reddy’s targets Roche’s Rituxan in Europe: Corporate India (Bloomberg Business Week) - "Dr. Reddy’s Laboratories...aims to be among the first three to four companies offering copies of biotechnology drugs, including a version of Roche Holding AG (ROG)’s Rituxan, in Europe....The companies [Reddy’s Laboratories & Merck Serono] aim to together develop, manufacture and commercialize a portfolio of four biosimilar drugs...copies of Roche’s blockbuster rituximab and Amgen Inc.’s blood-related therapies filgrastim, pegfilgrastim and darbepoetin alfa."

Anticipated launch Europe • Biosimilar • Hematological Malignancies

Precise therapy for lung cancer patients with rare sensitive mutations of epidermal growth factor receptor (PubMed, Zhonghua Zhong Liu Za Zhi) - "...Except for the above two mutations and T790M point mutation, the rest are rare mutations, including Ins19, Ins20, E709, G719, S768, L861 and some compound mutations...Currently, targeted drugs for Ins20 -Ap32788 mutation has entered into clinical trials...In conclusion, when patients with rare sensitive mutations received EGFR-TKIs therapy, the efficacy and progression-free survival time is similar to or slightly lower than those with classical sensitive mutations, whereas it is higher than those with wild-type EGFR. Compared with the first generation of EGFR-TKIs, second generation EGFR-TKIs may be more suitable for the treatment of lung cancer patients harboring rare sensitive EGFR mutations."

Clinical • Journal • Biosimilar • Lung Cancer • Oncology • Solid Tumor

Activity of the Hsp90 inhibitor Luminespib Among Non-Small Cell Lung Cancers Harboring EGFR Exon 20 Insertions. (PubMed, Ann Oncol) - P2; "There are currently no approved targeted therapies for non-small-cell lung cancer (NSCLC) patients with EGFR exon 20 insertions (ins20), a subgroup of EGFR mutations that are generally refractory to first/second generation EGFR inhibitors. Luminespib is generally well-tolerated, though reversible low-grade ocular toxicity is common. Further study of luminespib and other hsp90 inhibitors in this population is warranted."

Journal

Characterization of a Species-Specific Insulinase-Like Protease in Cryptosporidium parvum. (PubMed, Front Microbiol) - "Results of a comparative genomic analysis indicated that genes encoding two C. parvum-specific insulinase-like proteases (INS19 and INS20), cgd6_5510 and cgd6_5520, are lost in many Cryptosporidium species. We observed that INS20-19 is likely a protein with high expression in the apical region of sporozoites, and neutralization of the protein led to a partial reduction of parasite load in HCT-8 and MDBK cell cultures at 24 h. Taken together, our findings support the involvement of INS20-19 in the invasion or early developmental process of C. parvum."

Journal

Clinical activity of afatinib in a cohort of patients with lung adenocarcinoma harbouring uncommon EGFR mutations: A Spanish retrospective multicentre study (ELCC 2018) - "In clinical practice, afatinib was active in u-EGFRm NSCLC, particularly in complex and single mutations. Further strategies are needed for patients with ins20, a subgroup u-EGFRm with a lower clinical benefit from afatinib."

Retrospective data

Clinical activity of afatinib in a cohort of patients with lung adenocarcinoma harbouring uncommon EGFR mutations: A Spanish retrospective multicentre study (ELCC 2018) - "In clinical practice, afatinib was active in u-EGFRm NSCLC, particularly in complex and single mutations. Further strategies are needed for patients with ins20, a subgroup u-EGFRm with a lower clinical benefit from afatinib."

Retrospective data