Browsing by Author "Yoshioka H."

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    Amivantamab plus Lazertinib in Previously Untreated EGFR -Mutated Advanced NSCLC.
    (2024-10-24) Cho B.C.; Lu S.; Felip E.; Spira A.I.; Girard N.; Lee J.S.; Lee S.H.; Ostapenko Y.; Danchaivijitr P.; Liu B.; Alip A.; Korbenfeld E.; Mourão Dias J.; Besse B.; Lee K.H.; Xiong H.; How S.H.; Cheng Y.; Chang G.C.; Yoshioka H.; Yang J.C.H.; Thomas M.; Nguyen D.; Ou S.H.I.; Mukhedkar S.; Prabhash K.; D'Arcangelo M.; Alatorre-Alexander J.; Vázquez Limón J.C.; Alves S.; Stroyakovskiy D.; Peregudova M.; Şendur M.A.N.; Yazici O.; Califano R.; Gutiérrez Calderón V.; De Marinis F.; Passaro A.; Kim S.W.; Gadgeel S.M.; Xie J.; Sun T.; Martinez M.; Ennis M.; Fennema E.; Daksh M.; Millington D.; Leconte I.; Iwasawa R.; Lorenzini P.; Baig M.; Shah S.; Bauml J.M.; Shreeve S.M.; Sethi S.; Knoblauch R.E.; Hayashi H.; Cho B.C.; Mahidol University
    Background Amivantamab plus lazertinib (amivantamab-lazertinib) has shown clinically meaningful and durable antitumor activity in patients with previously untreated or osimertinib-pretreated EGFR (epidermal growth factor receptor)-mutated advanced non-small-cell lung cancer (NSCLC). Methods In a phase 3, international, randomized trial, we assigned, in a 2:2:1 ratio, patients with previously untreated EGFR-mutated (exon 19 deletion or L858R), locally advanced or metastatic NSCLC to receive amivantamab-lazertinib (in an open-label fashion), osimertinib (in a blinded fashion), or lazertinib (in a blinded fashion, to assess the contribution of treatment components). The primary end point was progression-free survival in the amivantamab-lazertinib group as compared with the osimertinib group, as assessed by blinded independent central review. Results Overall, 1074 patients underwent randomization (429 to amivantamab-lazertinib, 429 to osimertinib, and 216 to lazertinib). The median progression-free survival was significantly longer in the amivantamab-lazertinib group than in the osimertinib group (23.7 vs. 16.6 months; hazard ratio for disease progression or death, 0.70; 95% confidence interval [CI], 0.58 to 0.85; P<0.001). An objective response was observed in 86% of the patients (95% CI, 83 to 89) in the amivantamab-lazertinib group and in 85% of those (95% CI, 81 to 88) in the osimertinib group; among patients with a confirmed response (336 in the amivantamab-lazertinib group and 314 in the osimertinib group), the median response duration was 25.8 months (95% CI, 20.1 to could not be estimated) and 16.8 months (95% CI, 14.8 to 18.5), respectively. In a planned interim overall survival analysis of amivantamab-lazertinib as compared with osimertinib, the hazard ratio for death was 0.80 (95% CI, 0.61 to 1.05). Predominant adverse events were EGFR-related toxic effects. The incidence of discontinuation of all agents due to treatment-related adverse events was 10% with amivantamab-lazertinib and 3% with osimertinib. Conclusions Amivantamab-lazertinib showed superior efficacy to osimertinib as first-line treatment in EGFR-mutated advanced NSCLC. (Funded by Janssen Research and Development; MARIPOSA ClinicalTrials.gov number, NCT04487080.)
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    Amivantamab plus lazertinib versus osimertinib as first-line treatment in EGFR-mutated advanced non-small cell lung cancer: MARIPOSA Asian subset
    (2025-06-01) Cho B.C.; Hayashi H.; Lee J.S.; Lee S.H.; Danchaivijitr P.; Cheng Y.; Liu B.; Alip A.; Xiong H.; How S.H.; Chang G.C.; Yang J.C.H.; Yoshioka H.; Nahit Şendur M.A.; Prabhash K.; Azuma K.; Lee Y.G.; Lin C.C.; Matsumoto S.; Sunpaweravong P.; Xia Y.; Martinez M.; Bauml J.M.; Sethi S.; Lu S.; Cho B.C.; Mahidol University
    Introduction: The incidence of epidermal growth factor receptor (EGFR) mutations is higher among Asian patients with advanced non-small cell lung cancer than the general advanced non-small cell lung cancer population. We evaluated the efficacy and safety of amivantamab in combination with lazertinib versus osimertinib in Asian participants from the phase 3 MARIPOSA study who had treatment-naïve advanced non-small cell lung cancer with common EGFR mutations. Methods: Participants were randomized 2:2:1 to receive amivantamab-lazertinib, osimertinib alone, or lazertinib alone. The primary endpoint was progression-free survival based on blinded independent central review per RECIST v1.1. Secondary endpoints included overall survival, objective response rate, duration of response, and safety. Exploratory endpoints included extracranial progression-free survival and post-progression outcomes. Results: Of 1074 randomized participants, 629 were Asian, with 250 and 251 randomized to the amivantamab-lazertinib and osimertinib arms, respectively. Among Asian participants, at a median follow-up of 22.5 months, amivantamab-lazertinib showed a 35 % reduction in the risk of disease progression or death versus osimertinib (hazard ratio, 0.65; P < 0.001). Consistent with the overall population, median progression-free survival was 27.5 and 18.3 months in the amivantamab-lazertinib and osimertinib arms, respectively. The objective response rate was 88 % for amivantamab-lazertinib versus 85 % for osimertinib. The median duration of response among confirmed responders improved by 8.6 months for amivantamab-lazertinib versus osimertinib. Favorable trends were also seen for overall survival, extracranial progression-free survival, and post-progression outcomes for amivantamab-lazertinib over osimertinib. Adverse events in Asian participants were similar to those in the overall population. Conclusions: Amivantamab-lazertinib demonstrated superior progression-free survival versus osimertinib in Asian participants, with a tolerable safety profile. These results were consistent with those in the overall population.
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    Development and evaluation of an artificial intelligence (AI) -assisted chest x-ray diagnostic system for detecting, diagnosing, and monitoring tuberculosis
    (2025-01-01) Kaewwilai L.; Yoshioka H.; Choppin A.; Prueksaritanond T.; Ayuthaya T.P.N.; Brukesawan C.; Matupumanon S.; Kawabe S.; Shimahara Y.; Phosri A.; Kaewboonchoo O.; Kaewwilai L.; Mahidol University
    Objectives: To develop an artificial intelligence (AI)-assisted chest x-ray diagnostic system for the detection, differential diagnosis, and follow-up of tuberculosis (TB), and prove its usefulness. Methods: This is a retrospective study. In-house developed AI-assisted chest x-ray diagnostic system was used to identify and diagnose lung abnormalities in participants' chest x-rays and to compare imaging findings from two x-rays. First, 100 chest radiographs were reviewed including TB cases (N = 43) with positive sputum test confirmation and non-TB cases (N = 57) for initial diagnosis and differential diagnosis. Next, 45 pairs of TB cases from the identical patients were reviewed for follow-up. The AI system diagnosed TB and graded the comparison images into three categories (improved, stable, or worsening). The performance was evaluated by four expert radiologists or pulmonary medicine specialists. Results: The AI system demonstrated an exceptional sensitivity of 100 %, successfully identifying all 43 TB cases. Nevertheless, it is also susceptible to misclassify other diseases as TB, resulting in low specificity score of 66.7 %. The comparison function determined that expert physicians and AI-assisted chest x-ray diagnostic system were 58 % in exact agreement and 100 % in within one grade agreement. Conclusions: The AI system successfully detected all TB patients identified in this study and demonstrated a reasonable comparison function. Therefore, our AI assisted chest x-ray diagnostic system is feasible and practical for TB screening.
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    Overall Survival with Amivantamab-Lazertinib in EGFR-Mutated Advanced NSCLC
    (2025-10-30) Yang J.C.H.; Lu S.; Hayashi H.; Felip E.; Spira A.I.; Girard N.; Kim Y.J.; Lee S.H.; Ostapenko Y.; Danchaivijitr P.; Liu B.; Alip A.; Korbenfeld E.; Mourão Dias J.; Besse B.; Passaro A.; Lee K.H.; Xiong H.; How S.H.; Cheng Y.; Chang G.C.; Yoshioka H.; Thomas M.; Nguyen D.; Ou S.H.I.; Mukhedkar S.; Prabhash K.; D'Arcangelo M.; Alatorre-Alexander J.; Vázquez Limón J.C.; Alves S.; Stroyakovskiy D.; Peregudova M.; Şendur M.A.N.; Yazici O.; Califano R.; Gutiérrez Calderón V.; de Marinis F.; Kim S.W.; Gadgeel S.M.; Owen S.; Xie J.; Sun T.; Mehta J.; Venkatasubramanian R.; Ennis M.; Fennema E.; Daksh M.; Roshak A.; Man J.; Knoblauch R.E.; Bauml J.M.; Baig M.; Shah S.; Sethi S.; Cho B.C.; Yang J.C.H.; Mahidol University
    BACKGROUND: Previous results from this phase 3 trial showed that progression-free survival among participants with previously untreated EGFR (epidermal growth factor receptor)-mutated advanced non-small-cell lung cancer (NSCLC) was significantly improved with amivantamab-lazertinib as compared with osimertinib. Results of the protocol-specified final overall survival analysis in this trial have not been reported. METHODS: We randomly assigned, in a 2:2:1 ratio, participants with previously untreated EGFR-mutated (exon 19 deletion or L858R substitution), locally advanced or metastatic NSCLC to receive amivantamab-lazertinib, osimertinib, or lazertinib. Overall survival (assessed in an analysis of the time from randomization to death from any cause) in the amivantamab-lazertinib group as compared with the osimertinib group was a key secondary end point. Additional end points included safety. RESULTS: A total of 429 participants each were assigned to receive amivantamab-lazertinib or osimertinib. Over a median follow-up of 37.8 months, amivantamab-lazertinib led to significantly longer overall survival than osimertinib (hazard ratio for death, 0.75; 95% confidence interval, 0.61 to 0.92; P = 0.005); 3-year overall survival was 60% and 51%, respectively. At the clinical cutoff date, 38% of participants in the amivantamab-lazertinib group and 28% in the osimertinib group were still receiving the assigned treatment. Adverse events of grade 3 or higher were more common with amivantamab-lazertinib (in 80% of participants) than with osimertinib (in 52%), particularly skin-related events, venous thromboembolism, and infusion-related events; these findings were consistent with the established safety profile of each treatment. No new safety signals were observed with additional follow-up. CONCLUSIONS: Amivantamab-lazertinib led to significantly longer overall survival among participants with previously untreated EGFR-mutated advanced NSCLC than osimertinib but was associated with an increased risk of adverse events of grade 3 or higher. (Funded by Janssen Research and Development; MARIPOSA ClinicalTrials.gov number, NCT04487080.).