Publications by authors named "Sang-we Kim"

Introduction: We describe the safety of sotorasib monotherapy in patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) and discuss practical recommendations for managing key risks.

Methods: Incidence rates of treatment-related adverse events (TRAEs) were pooled from 4 clinical trials: CodeBreaK 100 (NCT03600883), CodeBreaK 101 (NCT04185883), CodeBreaK 105 (NCT04380753), and CodeBreaK 200 (NCT04303780) and graded according to CTCAE v5.0.

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  • - The study investigates the role of thyroid immune-related adverse events (irAEs) in predicting the effectiveness of PD-1 blockade for treating non-small cell lung cancer (NSCLC), revealing they are independent of PD-L1 expression.
  • - Out of 71 metastatic NSCLC patients analyzed, those with thyroid irAE showed significantly longer progression-free survival compared to those without, indicating that thyroid irAEs can serve as a useful biomarker in treatment outcomes.
  • - Alternative staging methods that incorporate thyroid irAEs improved the prognostic accuracy for disease progression compared to standard TNM staging, emphasizing the importance of these irAEs in identifying patients likely to respond well to PD-1 blockade therapies.
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  • Lazertinib is a new type of medicine that helps treat a kind of lung cancer called NSCLC, especially for people whose cancer got worse after other treatments.
  • In a study with 78 patients, those taking lazertinib lived for an average of about 39 months and had good survival rates at 1, 2, and 3 years.
  • The study found that checking for certain cancer genes in the blood can help predict how well patients will respond to lazertinib treatment.
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Introduction: Previous results from the phase 3 ALESIA study (NCT02838420) revealed that alectinib (a central nervous system [CNS]-active, ALK inhibitor) had clinical benefits in treatment-naïve Asian patients with advanced -positive NSCLC, consistent with the global ALEX study. We present updated data after more than or equal to 5 years of follow-up from the "last patient in" date.

Methods: Adult patients with treatment-naïve, advanced -positive NSCLC from mainland China, South Korea, and Thailand were randomized 2:1 to receive twice-daily 600 mg alectinib (n = 125) or 250 mg crizotinib (n = 62).

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Introduction: The primary analysis (median follow-up 34.9 mo across all arms) of the phase 3 POSEIDON study revealed a statistically significant overall survival (OS) improvement with first-line tremelimumab plus durvalumab and chemotherapy (T+D+CT) versus CT in patients with EGFR and ALK wild-type metastatic NSCLC (mNSCLC). D+CT had a trend for OS improvement versus CT that did not reach statistical significance.

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  • FGFR genomic alterations are found in 5-10% of human cancers, and erdafitinib has shown promise in treating various advanced solid tumors but its effectiveness in Asian patients was unclear.
  • A phase IIa study was conducted to assess the efficacy of erdafitinib in Asian patients with FGFR-altered advanced cholangiocarcinoma, non-small cell lung cancer (NSCLC), and esophageal cancer by evaluating various response rates and survival metrics.
  • Results indicated a 40.9% objective response rate in cholangiocarcinoma patients, while NSCLC did not show any objective responses; however, all patients experienced adverse effects, highlighting the need for further safety assessment.
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  • The JAVELIN Lung 101 trial tested avelumab, an immune checkpoint inhibitor, alongside lorlatinib or crizotinib (tyrosine kinase inhibitors) in advanced non-small cell lung cancer (NSCLC).
  • The study aimed to determine the maximum tolerated dose (MTD) and evaluate the treatment's effectiveness based on patient response rates, focusing on dose-limiting toxicities (DLTs).
  • Results showed that avelumab with lorlatinib was manageable with a response rate of 52%, while avelumab with crizotinib was less feasible, with a lower response rate of 25% and high DLT incidence.
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Purpose: The Korean Cancer Study Group (KCSG) is a nationwide cancer clinical trial group dedicated to advancing investigator-initiated trials (IITs) by conducting and supporting clinical trials. This study aims to review IITs conducted by KCSG and quantitatively evaluate the survival and financial benefits of IITs for patients.

Materials And Methods: We reviewed IITs conducted by KCSG from 1998 to 2023, analyzing progression-free survival (PFS) and overall survival (OS) gains for participants.

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  • - The study investigates the effectiveness of amivantamab plus lazertinib compared to osimertinib in treating patients with advanced non-small-cell lung cancer (NSCLC) caused by specific genetic mutations.
  • - Results showed that patients receiving the amivantamab-lazertinib treatment had a significantly longer progression-free survival (23.7 months) than those on osimertinib (16.6 months), and the response rate was similar among both groups.
  • - Side effects primarily related to treatment were noted, but the overall survival analysis indicated a potential benefit for amivantamab-lazertinib over osimertinib, with fewer serious complications leading to treatment discontinuation.
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  • This study investigates the efficacy, safety, and pharmacokinetics of an 80 mg daily dose of osimertinib in patients with leptomeningeal metastases (LMs) who have previously been treated with other EGFR tyrosine kinase inhibitors (TKIs).
  • A total of 73 patients were treated, and findings include a median overall survival of 15.6 months and a 51.6% objective response rate, indicating substantial effectiveness in controlling the disease.
  • The results support the use of osimertinib as a promising treatment option for patients with EGFR-mutated non-small cell lung cancer who develop LMs, highlighting its significant intracranial activity and manageable safety profile.
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  • The KINDLE-Korea study focused on treatment patterns and outcomes for patients with stage III non-small cell lung cancer (NSCLC) diagnosed from 2013 to 2017.
  • It included 461 patients, predominantly older men with a high percentage of smokers, and found varied treatment approaches, with many receiving chemoradiation or surgery.
  • The study highlighted differences in survival outcomes and identified a need for better treatment options for patients not eligible for surgery, especially before durvalumab became available.
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  • The study compares the effectiveness of atezolizumab plus cabozantinib versus docetaxel in patients with advanced non-small cell lung cancer (NSCLC) who did not respond to prior immunotherapy and chemotherapy.
  • Results showed similar overall survival rates: 10.7 months for the combination treatment and 10.5 months for docetaxel, with both showing comparable median progression-free survival.
  • Adverse events were reported in both treatment groups; however, a higher percentage of serious adverse events occurred in those receiving atezolizumab plus cabozantinib compared to docetaxel.
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Introduction: For patients with unresectable, stage III non-small-cell lung cancer (NSCLC), current standard of care is concurrent chemoradiotherapy (cCRT) followed by consolidation durvalumab. However, earlier initiation of durvalumab simultaneously with cCRT may increase antitumor activity relative to initiation after cCRT. The phase 1 CLOVER study (NCT03509012) evaluated durvalumab combined with cCRT in patients with advanced solid tumors; we report findings from the NSCLC cohort.

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  • The LASER201 study analyzed the effectiveness and safety of lazertinib 240 mg as a first-line treatment for patients with EGFR-mutated non-small cell lung cancer (NSCLC) who had not undergone prior EGFR tyrosine kinase inhibitor therapy.
  • Out of 43 participants, the study found a 70% objective response rate and an 86% disease control rate, with a median duration of response and progression-free survival of 23.5 months and 24.6 months, respectively.
  • The treatment had a tolerable safety profile, with the most common side effects being rash and diarrhea, while no severe drug-related side effects were reported, indicating a long-term
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For patients with non-small-cell lung cancer (NSCLC) tumors without currently targetable molecular alterations, standard-of-care treatment is immunotherapy with anti-PD-(L)1 checkpoint inhibitors, alone or with platinum-doublet therapy. However, not all patients derive durable benefit and resistance to immune checkpoint blockade is common. Understanding mechanisms of resistance-which can include defects in DNA damage response and repair pathways, alterations or functional mutations in STK11/LKB1, alterations in antigen-presentation pathways, and immunosuppressive cellular subsets within the tumor microenvironment-and developing effective therapies to overcome them, remains an unmet need.

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  • - The study focuses on the increasing significance of exon 20 insertion mutations (E20ins) in EGFR and HER2 within non-small cell lung cancer (NSCLC) patients, highlighting the growing number of targeted therapies available for these mutations.
  • - Between December 2013 and July 2021, researchers identified E20ins in 107 patients, with a notable discordance rate of 53.1% between identification methods (PCR and NGS) for EGFR mutations, indicating the importance of using advanced testing methods like NGS for accurate detection.
  • - The results showed that targeted therapies for E20ins significantly outperformed traditional platinum-based treatments, achieving better objective response rates and progression-free survival, underscoring
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Purpose: The phase III CheckMate 722 trial (ClinicalTrials.gov identifier: NCT02864251) evaluated nivolumab plus chemotherapy versus chemotherapy in patients with epidermal growth factor receptor ()-mutated metastatic non-small-cell lung cancer (NSCLC) after disease progression on EGFR tyrosine kinase inhibitors (TKIs).

Methods: Patients with disease progression after first- or second-generation EGFR TKI therapy (without T790M mutation) or osimertinib (with/without T790M mutation) were randomly assigned 1:1 to nivolumab (360 mg once every 3 weeks) plus platinum-doublet chemotherapy (once every 3 weeks) or platinum-doublet chemotherapy alone (once every 3 weeks) for four cycles.

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  • This study investigated the effects of adding durvalumab, an immunotherapy drug, to treatment in patients with unresectable locally advanced non-small cell lung cancer (LA-NSCLC) who had already received concurrent chemoradiotherapy (CCRT).
  • Results showed that patients receiving durvalumab after CCRT had significantly improved progression-free survival (20.9 months vs. 13.7 months) and better local control rates (57.3% vs. 38.8%) than those who only received CCRT.
  • The findings indicate that durvalumab is beneficial in extending survival and controlling disease in LA-NSCLC patients, particularly for those expressing the PD-L1 biomarker, thus supporting its inclusion in standard
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  • The study evaluates the effectiveness and safety of repotrectinib, a new ROS1 tyrosine kinase inhibitor, in treating advanced solid tumors, focusing on fusion-positive non-small-cell lung cancer (NSCLC) and resistance mutations like G2032R.
  • The phase 2 trial involved patients who had not previously received ROS1 TKIs, showing a 79% response rate among these individuals, with a median response duration of 34.1 months.
  • Common side effects reported included dizziness (58%), dysgeusia (taste changes, 50%), and paresthesia (tingling sensations).
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  • Canakinumab, a monoclonal antibody targeting IL-1β, was tested in a phase III study (CANOPY-1) to see if it could improve survival rates in patients with advanced non-small-cell lung cancer (NSCLC) when combined with pembrolizumab and chemotherapy.
  • The study involved 643 patients split between canakinumab and placebo groups, with results showing no significant difference in progression-free survival (PFS) or overall survival (OS) after a median follow-up of 21.2 months.
  • While safety profiles were similar, canakinumab treatment led to delays in worsening symptoms like chest pain, coughing, and shortness of breath, suggesting it might
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Objectives: In the phase 3 POSEIDON study, first-line tremelimumab plus durvalumab and chemotherapy significantly improved overall survival and progression-free survival versus chemotherapy in metastatic non-small-cell lung cancer (NSCLC). We present patient-reported outcomes (PROs).

Patients And Methods: Treatment-naïve patients were randomized 1:1:1 to tremelimumab plus durvalumab and chemotherapy, durvalumab plus chemotherapy, or chemotherapy.

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Background: Osimertinib is a third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) that is selective for EGFR-TKI-sensitizing and T790M resistance mutations. Evidence suggests that the addition of chemotherapy may extend the benefits of EGFR-TKI therapy.

Methods: In this phase 3, international, open-label trial, we randomly assigned in a 1:1 ratio patients with -mutated (exon 19 deletion or L858R mutation) advanced non-small-cell lung cancer (NSCLC) who had not previously received treatment for advanced disease to receive osimertinib (80 mg once daily) with chemotherapy (pemetrexed [500 mg per square meter of body-surface area] plus either cisplatin [75 mg per square meter] or carboplatin [pharmacologically guided dose]) or to receive osimertinib monotherapy (80 mg once daily).

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  • The study investigates sex differences in adverse events (AEs) from chemotherapy, focusing on how these differences affect healthcare use and treatment outcomes in female patients.
  • Results show that women experienced more frequent and severe AEs like nausea and neutropenia, leading to lower chemotherapy dose intensity and more dose reductions than men.
  • The findings highlight the need for physicians to consider gender-specific responses to chemotherapy when making treatment decisions.
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  • This study explores MRI-based endpoints for evaluating brain metastasis (BM) patients receiving immunotherapy, as traditional response criteria may not be effective.
  • It involved 63 non-small cell lung cancer patients and assessed different measurement methods (mRECIST, RANO-BM, and iRANO-BM) to determine tumor response, overall response rate (ORR), and progression-free survival (PFS).
  • The findings suggest that volumetry is a strong predictor of overall survival (OS), outperforming some traditional diameter-based metrics, highlighting the importance of accurate measurement techniques in clinical trials.
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