How might treatment of <i>ALK</i>-positive non-small cell lung cancer change in the near future?

Metro, Giulio; Bellezza, Guido; Puma, Francesco; Chiari, Rita

doi:10.1080/14737140.2016.1226138

Cited by 3 publications

(1 citation statement)

References 19 publications

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“…Anaplastic lymphoma kinase, a kind of tyrosine kinase inhibitor (TKI) is recently used in various cancer treatments. Rearrangement of the anaplastic lymphoma kinase (ALK) gene is responsible for 5% of non-small cell lung cancers (NSCLCs) [4]. Brigatinib is the novel second-generation ALK-TKI which has shown preclinical activity, with consistent clinical efficacy in crizotinib-intolerable patients [5,6,7,8,9].…”

Section: Graphical Abstract 1 Introductionmentioning

confidence: 99%

Development and Validation of RP-HPLC Method for the Determination of Anticancer Drug Brigatinib

Akter¹,

Hossain²,

Alam³

et al. 2023

GSC Biol. Pharm. Sci.

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Now-a-days, one of the most devastating and life-threatening disorders is cancer. Various types of cancer based on the organ affected are namely lung cancer, breast cancer, stomach cancer, colon cancer etc. A number of anticancer drugs are obtainable among which tyrosine kinase inhibitor is the superior one. The available tyrosine kinase inhibitors are namely Crizotinib, Ibrutinib, Osimertinib, Brigatinib. Among them, brigatinib is the recent INN drug which belongs to second generation of tyrosine kinase inhibitor and indicated for non-small cell lung cancer. Literature review shows that there are no developed methods available for determination of brigatinib except UPLC method. In the present study, authors aimed to develop and validate RP-HPLC method for determination of brigatinib. Regarding RP-HPLC method, C18 column (ID: 5 micron*100 Å) was employed as stationary phase while combination of methanol and distilled water (75%:25%) was used as mobile phase. The retention time of brigatinib was found 5.6 min from the chromatogram. The regression equation was y = 53344x - 239.6 with coefficient of determination (R2) 0.999 and correlation coefficient (r) 0.9994; indicating excellent linearity of the calibration curve obtained by the newly developed method. Percent (%) RSD for robustness, ruggedness, precision was below 2. Limit of detection and limit of quantification were found to be 0.332 μg/mL and 1.00 μg/mL, respectively. The findings ensure the suitability of the developed method as an established one to assay brigatinib in any quality control laboratory.

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Section: Graphical Abstract 1 Introductionmentioning

confidence: 99%

Development and Validation of RP-HPLC Method for the Determination of Anticancer Drug Brigatinib

Akter¹,

Hossain²,

Alam³

et al. 2023

GSC Biol. Pharm. Sci.

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Brigatinib for anaplastic lymphoma kinase-tyrosine kinase inhibitor naïve anaplastic lymphoma kinase-positive advanced non-small cell lung cancer: an effective but still broken option

Ricciuti

Roila

Metro

2019

Transl Lung Cancer Res

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Rearrangements of the anaplastic lymphoma kinase (ALK) gene occur in approximately 5% of non-small cell lung cancers (NSCLCs), in which they identify a distinct subtype of lung tumor that shows exquisite sensitivity to therapy with ALK tyrosine kinase-inhibitors (ALK-TKIs) (1).Despite durable responses to the first-generation ALK-TKI crizotinib, the development of acquired resistance occurs in virtually all patients (2). From a biological standpoint, resistance to crizotinib develops either by 'on target' (ALK secondary mutations in the tyrosine kinase domain or ALK amplification) or 'off target' mechanisms (activation of signaling pathways other than ALK) (3). The novel second-generation ALK-TKI brigatinib has shown preclinical activity against a wide spectrum of ALK secondary mutations associated with resistance to crizotinib, and consistently, it proved to be clinically effective in crizotinib-refractory patients (4-6). Against this background, in September 2018, Camidge and colleagues reported in the New England Journal of Medicine the eagerly awaited results of the 'ALTA-1L' trial, which compared brigatinib with crizotinib in ALK-TKI naïve patients with ALK-positive advanced NSCLC (7). Study overview'ALTA-1L' is a multicenter, randomized, open-label, phase 3 trial that allocated 275 patients with ALK-TKI naïve ALK-positive advanced NSCLC in a 1:1 ratio to either brigatinib 180 mg once daily (after a 7 days lead-in phase at 90 mg; N=137) or crizotinib 250 mg twice daily (N=138) (7). Crossover to brigatinib was allowed for patients in the crizotinib arm, upon confirmation of disease progression by blinded independent review assessment. The primary endpoint of the study was progression-free survival (PFS), while secondary endpoints included objective response rate (ORR), intracranial ORR (IORR), intracranial PFS, and overall survival. The first pre-specified interim analysis was performed at 50% of expected events (99/198). With a median follow-up of 11.0 months in the brigatinib group and 9.3 months in the crizotinib group, blinded independent review-assessed PFS was significantly longer for brigatinib [median PFS not reached versus 9.8 months (95% CI, 9.0-12.9 months), respectively], with an estimated 12-month progression-free rate of 67% (95% CI, 56-75%) versus 43% (95%, CI, 32-53%), respectively, and a hazard ratio (HR) for progression or death of 0.49 in favor of brigatinib [(95% CI, 0.33-0.74), P<0.001]. The subgroup analysis showed that brigatinib was superior to crizotinib across several clinical characteristics, including performance status (0 or 1), presence of brain metastases (BMs) at baseline, and prior exposure to chemotherapy for advanced disease (the study allowed

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Development and Validation of Uv-Vis Spectroscopic Method for the Determination of Anticancer Drug Brigatinib

Akter,

Hossain,

Saikh

et al. 2023

Preprint

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How might treatment of ALK-positive non-small cell lung cancer change in the near future?

Cited by 3 publications

References 19 publications

Development and Validation of RP-HPLC Method for the Determination of Anticancer Drug Brigatinib

Development and Validation of RP-HPLC Method for the Determination of Anticancer Drug Brigatinib

Brigatinib for anaplastic lymphoma kinase-tyrosine kinase inhibitor naïve anaplastic lymphoma kinase-positive advanced non-small cell lung cancer: an effective but still broken option

Development and Validation of Uv-Vis Spectroscopic Method for the Determination of Anticancer Drug Brigatinib

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