Brigatinib in
            <i>ALK</i>
            -positive non-small cell lung cancer: real-world data in the Latin American population (Bri-world extend CLICaP)

Heredia, David; Barrón, Feliciano; Cardona, Andrés Felipe; Campos, S.; Rodríguez-Cid, Jerónimo Rafael; Martínez-Barrera, Luis Manuel; Alatorre, Jorge; Salinas, Miguel Ángel Cruz; Lara‐Mejía, Luis; Flores‐Estrada, Diana; Arrieta, Óscar

doi:10.2217/fon-2020-0747

Cited by 7 publications

(12 citation statements)

References 37 publications

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“…TTD was used as a surrogate endpoint for PFS to assess the effectiveness and treatment duration of brigatinib in our analyses, consistent with other real-world studies on ALK-TKIs. 17 , 18 , 20 A correlation between TTD and PFS was observed in a post hoc analysis ( r = . 87) and a pooled analysis ( r = .…”

Section: Discussionmentioning

confidence: 89%

“… 19 Treatment patterns for ALK-TKI usage and brigatinib sequencing in this study were aligned with the FDA approvals and access timings, as well as the approved indications, and were similar to a recent US-based real-world study, 20 and studies on patients from the brigatinib early-access program (EAP). 17 , 18 …”

Section: Discussionmentioning

confidence: 99%

“… 17 The probability of continued brigatinib therapy at 12 months in this study (43.5%) was consistent with a global real-world study (48.6%) and a study involving Latin American population (59.9%). 17 , 18 After discontinuing brigatinib, most patients were treated with another ALK TKI and benefited from the subsequent treatments, suggesting that brigatinib could be used in earlier lines.…”

Section: Discussionmentioning

confidence: 99%

“… 17 Another real-world retrospective analysis of the Latin American population in the EAP by Heredia et al showed similar positive trends for brigatinib. 18 …”

Section: Introductionmentioning

confidence: 99%

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Real-World Efficacy and Tolerability of Brigatinib in Patients with Non-Small Cell Lung Cancer with Prior ALK-TKIs in the United States

Jahanzeb

Lin

et al. 2022

The Oncologist

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Background Real-world evidence for brigatinib, a next-generation anaplastic lymphoma kinase-tyrosine kinase inhibitor (ALK-TKI) used in ALK-rearranged non-small cell lung cancer, is scarce. This retrospective study evaluated real-world brigatinib utilization in the US post other ALK-TKIs. Materials and Methods Adults with ≥1 brigatinib claim (index date) between 1 April 2017 and 30 September 2020 in the IQVIA longitudinal pharmacy claims database were followed until dose reduction, discontinuation, or end of follow-up. Patients had ≥12 months pre– and ≥1-month post–index observations. Results A total of 413 patients treated with brigatinib were analyzed. Over 80% received ≥1 prior ALK-TKI; alectinib and crizotinib were the most common (58.8% and 51.3% patients, respectively). The median follow-up was 8.4 months. The median time to treatment discontinuation (TTD) for brigatinib was 10.3 months (95% CI, 8.2-15.0), with 45% remaining on therapy at 12 months. The TTD was shortest (~8 months) in patients receiving both crizotinib and alectinib and longest in patients who received alectinib only prior to brigatinib (11.8 months). Adherence was high, with 92.7% of patients having a medication possession ratio of >80%. The mean dose compliance score was 1.0. Most patients reached the brigatinib dose of 180 mg/day (77%); 13.2% of patients had a dose reduction, with 89.3% and 84.6% continuing 180 mg/day therapy at 3 and 6 months, respectively. Conclusions Brigatinib appears to be effective and well-tolerated in the real-world ALK+ NSCLC population in the US, showing benefit in patients after a next-generation ALK-TKI. Notably, dose reduction rates appeared markedly less than those seen in trials when most trial-related dose reductions were for asymptomatic laboratory abnormalities.

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Section: Discussionmentioning

confidence: 89%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

“… 17 Another real-world retrospective analysis of the Latin American population in the EAP by Heredia et al showed similar positive trends for brigatinib. 18 …”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Real-World Efficacy and Tolerability of Brigatinib in Patients with Non-Small Cell Lung Cancer with Prior ALK-TKIs in the United States

Jahanzeb

Lin

et al. 2022

The Oncologist

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“…At the end of the study, respective 3-year PFS determined by a blinded independent review committee was 43% vs. 19%, with a median OS not reached (NR) for either group. At present, several alternatives to crizotinib are available [ 10 , 11 , 12 , 13 , 14 , 15 ], rendering real-life data essential [ 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 ] to attempt to evaluate optimal therapeutic sequences [ 28 ].…”

Section: Introductionmentioning

confidence: 99%

Brigatinib for Pretreated, ALK-Positive, Advanced Non-Small-Cell Lung Cancers: Long-Term Follow-Up and Focus on Post-Brigatinib Lorlatinib Efficacy in the Multicenter, Real-World BrigALK2 Study

Descourt¹,

Pérol

Rousseau-Bussac

et al. 2022

Cancers

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Brigatinib is a next-generation ALK inhibitor (ALKi) that shows efficacy in ALK inhibitor naïve and post-crizotinib ALK+ advanced NSCLCs (aNSCLCs). The efficacy of brigatinib was retrospectively assessed in patients with aNSCLCs included in the brigatinib French Early-Access Program (1 August 2016–21 January 2019). The primary endpoint was investigator-assessed progression-free survival (invPFS) and the primary analysis was updated in 2021 with a longer follow-up, focused on post-brigatinib lorlatinib efficacy. Sixty-six centers included 183 patients: median age 60 ± 12.7 years; 78.3% never/former smokers; median of 3 ± 1 previous lines and 2 ± 0.5 ALKis; 37.1% ECOG PS 2 and 55.6% >3 metastatic sites. The median follow-up from brigatinib initiation was 40.4 months (95% CI 38.4–42.4). InvPFS was 7.4 months (95% CI 5.9–9.6), median duration of treatment (mDOT) was 7.3 months (95% CI 5.8–9.4) and median overall survival (mOS) was 20.3 months (95% CI 15.6–27.6). The median DOT and OS from brigatinib initiation tend to decrease with the number of ALK inhibitors used in previous lines of therapy. Based on the data collected, 92 (50.3%) patients received ≥1 agent(s) post-brigatinib and 68 (73.9%) of them received lorlatinib, with 51 (75%) immediately receiving it post-brigatinib, 12 (17.6%) receiving it after one and 5 (7.4%) after ≥2 subsequent treatments. The median follow-up was 29.9 (95% CI 25.7–33.1) months. Lorlatinib mDOT was 5.3 (95% CI 3.6–7.6) months with a median OS from lorlatinib initiation of 14.1 (95% CI 10.3–19.2) months. The results of the brigALK2 study confirm the efficacy of brigatinib in a population of heavily pretreated ALK+ aNSCLC patients and provide new data on the activity of lorlatinib after brigatinib.

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Real‐world evidence of brigatinib as second‐line treatment after crizotinib for ALK+ non‐small cell lung cancer using South Korean claims data (K‐AREAL)

Lee,

Nam,

Kwon

et al. 2024

Cancer Medicine

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PurposeThere is a lack of real‐world data in Asian populations for brigatinib, a next‐generation anaplastic lymphoma kinase (ALK) inhibitor for patients with non‐small cell lung cancer (NSCLC). This study analysed real‐world outcomes and dosing patterns for brigatinib in patients with crizotinib‐refractory ALK+ NSCLC in South Korea.MethodsThis retrospective, non‐interventional, cohort study used South Korean Health Insurance and Review Assessment claims data for adults with ALK+ NSCLC who initiated brigatinib between 19 April 2019 and 31 March 2021 after receiving prior crizotinib. Patients' characteristics, time to discontinuation (TTD), time to dose reduction, overall survival (OS) and treatment adherence were assessed.ResultsThe study included 174 patients (56.9% male; 27.0% with a history of brain metastases). Median duration of prior crizotinib was 17 (range 0.3–48) months. Median follow‐up after brigatinib initiation was 18 (range 0–34) months. Overall, 88.5% of patients received full‐dose brigatinib (180 mg/day) and 93.1% of patients were adherent (proportion of days covered ≥0.8). The median TTD was 24.9 months (95% CI 15.2–not reached). The probability of continuing treatment was 63.2% at 1 year and 51.5% at 2 years. The probability of continuing at full or peak dose was 79.7% at 1 year and 75.6% at 2 years. Median OS was not reached. The 2‐year OS rate was 68.7%.ConclusionsIn this first nationwide retrospective study using national insurance claim data, brigatinib demonstrated real‐world clinical benefit as second‐line treatment after prior crizotinib in ALK+ NSCLC patients in South Korea.

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Brigatinib in ALK -positive non-small cell lung cancer: real-world data in the Latin American population (Bri-world extend CLICaP)

Cited by 7 publications

References 37 publications

Real-World Efficacy and Tolerability of Brigatinib in Patients with Non-Small Cell Lung Cancer with Prior ALK-TKIs in the United States

Real-World Efficacy and Tolerability of Brigatinib in Patients with Non-Small Cell Lung Cancer with Prior ALK-TKIs in the United States

Brigatinib for Pretreated, ALK-Positive, Advanced Non-Small-Cell Lung Cancers: Long-Term Follow-Up and Focus on Post-Brigatinib Lorlatinib Efficacy in the Multicenter, Real-World BrigALK2 Study

Real‐world evidence of brigatinib as second‐line treatment after crizotinib for ALK+ non‐small cell lung cancer using South Korean claims data (K‐AREAL)

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