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Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
New
Title:

Alecensa Approved by the European Commission as the First Adjuvant Treatment for People with ALK-Positive Early-Stage Non-Small Cell Lung Cancer

Published date:
06/10/2024
Excerpt:
...European Commission has approved a Chugai originated anaplastic lymphoma kinase (ALK) inhibitor Alecensa® (generic name : alectinib) monotherapy, as adjuvant treatment following tumour resection for adult patients with ALK-positive non-small cell lung cancer (NSCLC) at high risk of recurrence (Stage IB [tumors ≥ 4 cm]–IIIA NSCLC [7ᵗʰ edition UICC/AJCC]).
Evidence Level:
Sensitive: A1 - Approval
Source:
Title:

FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer

Published date:
04/18/2024
Excerpt:
On April 18, 2024, the Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc.) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.
Evidence Level:
Sensitive: A1 - Approval
Title:

China National Drug Administration grants rapid approval of Roche’s Alecensa (alectinib) as a treatment for ALK-positive lung cancer

Published date:
08/20/2018
Excerpt:
Roche...announced that the China National Drug Administration (CNDA) has granted marketing authorisation for Alecensa (alectinib) as a monotherapy treatment for patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC).
Evidence Level:
Sensitive: A1 - Approval
Title:

Alectinib (Alecensa) is accepted for use within NHSScotland

Published date:
07/06/2018
Excerpt:
Alectinib (Alecensa) is accepted for use within NHS Scotland...as monotherapy for first line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
Evidence Level:
Sensitive: A1 - Approval
Published date:
02/16/2017
Excerpt:
Alecensa as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)....Alecensa as monotherapy is indicated for the treatment of adult patients with ALK‑positive advanced NSCLC previously treated with crizotinib.
Evidence Level:
Sensitive: A1 - Approval
Source:
Published date:
12/11/2015
Excerpt:
ALECENSA is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
Evidence Level:
Sensitive: A2 - Guideline
Source:
Title:

Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

Excerpt:
Alectinib is associated with longer PFS and lower toxicity than crizotinib and showed activity against CNS disease in patients previously untreated with ALK-positive NSCLC [I, A]
DOI:
Ann Oncol (2018) 29 (suppl 4): iv192–iv237
Evidence Level:
Sensitive: A2 - Guideline
Source:
Excerpt:
…the NCCN NSCLC Panel preference stratified the first-line therapy regimens and decided that brigatinib and ceritinib are "other recommended" options for patients with ALK-positive metastatic NSCLC; alectinib is the preferred first-line therapy option for ALK-positive metastatic NSCLC.
Evidence Level:
Sensitive: B - Late Trials
Title:

Roche Garners FDA Priority Review for Alecensa Application in Adjuvant ALK-Positive Lung Cancer

Published date:
01/30/2024
Excerpt:
...US Food and Drug Administration has accepted its supplemental new drug application (sNDA) seeking approval for the ALK inhibitor Alecensa (alectinib) as adjuvant therapy for early-stage ALK-positive non-small cell lung cancer...The FDA has granted Roche's sNDA priority review and is assessing it under its Real-Time Oncology Review pilot program...
Evidence Level:
Sensitive: B - Late Trials
Title:

Roche’s Alecensa delivers unprecedented Phase III results for people with ALK-positive early-stage lung cancer

Published date:
09/01/2023
Excerpt:
Roche...announced today that the Phase III ALINA study evaluating Alecensa® (alectinib), compared with platinum-based chemotherapy, met its primary endpoint of disease-free survival (DFS) at a prespecified interim analysis. Alecensa demonstrated a statistically significant and clinically meaningful improvement in DFS as adjuvant therapy in people with completely resected stage IB (tumour ≥4cm) to IIIA (UICC/AJCC 7th edition) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

LBA11 - Alectinib (ALC) vs crizotinib (CRZ) in Asian patients (pts) with treatment-naïve advanced ALK+ non-small cell lung cancer (NSCLC): 5-year update from the phase III ALESIA study

Published date:
11/28/2022
Excerpt:
Pts had stage IIIB/IV ALK+ NSCLC by central IHC and ECOG PS 0–2…a durable PFS benefit was seen for ALC vs CRZ (HR 0.33, 95% CI 0.23–0.49; median PFS [INV] 41.6 vs 11.1 m) and a clinically meaningful improvement in OS (HR 0.60, 95% CI 0.37–0.99; 5-year OS rate 66.4 vs 56.0%....PFS/OS benefit of ALC occurred in pts with or without CNS mets at baseline (Table) and across pre-specified subgroups.....With ≥5 years follow-up, 1L alectinib 600mg BID continues to provide clinical benefit to Asian pts with advanced ALK+ NSCLC, with no new safety concerns.
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

P84.08 - First-line Brigatinib in Anaplastic Lymphoma Kinase-positive Non-small Cell Lung Cancer: A Network Meta-Analysis

Published date:
01/12/2021
Excerpt:
...phase II or III randomized controlled trials (RCTs) in ALK inhibitor-naïve ALK-positive NSCLC patients...brigatinib significantly reduced the risk of disease progression or death...No significant differences were observed between brigatinib and alectinib in IRC-assessed (HR, 0.98; 95% CI, 0.61-1.57) or investigator-assessed PFS (HR, 1.01; 95% CI, 0.64-1.58) for overall patients...
Evidence Level:
Sensitive: B - Late Trials
Title:

Final PFS analysis and safety data from the phase III J-ALEX study of alectinib (ALC) vs. crizotinib (CRZ) in ALK-inhibitor naïve ALK-positive non-small cell lung cancer (ALK+ NSCLC)

Published date:
05/26/2019
Excerpt:
ALK+ NSCLC (by IHC and FISH or RT-PCR) patients were randomized 1:1 either to receive ALC (300 mg BID, n = 103) or CRZ (250 mg BID, n = 104)....In the final PFS analysis, ALC continued to demonstrate the superiority in IRF-PFS in ALK-inhibitor naïve ALK+ NSCLC...
DOI:
10.1200/JCO.2019.37.15_suppl.9092
Evidence Level:
Sensitive: B - Late Trials
Title:

FDA grants Roche’s Alecensa Priority Review for initial treatment of people with ALK-positive lung cancer

Published date:
08/03/2017
Excerpt:
Roche...announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review for Alecensa (alectinib) as an initial (first-line) treatment for people with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
Evidence Level:
Sensitive: B - Late Trials
Title:

Chugai’s Alecensa Receives Breakthrough Therapy Designation from FDA for First-Line Treatment of ALK Positive Non-Small Cell Lung Cancer

Published date:
10/04/2016
Excerpt:
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the first-line treatment of ALK positive non-small cell lung cancer (NSCLC) to Alecensa, a highly selective ALK inhibitor created by Chugai.
Evidence Level:
Sensitive: B - Late Trials
Title:

Alectinib (ALC) versus crizotinib (CRZ) in ALK-inhibitor naive ALK-positive non-small cell lung cancer (ALK+ NSCLC): Primary results from the J-ALEX study

Published date:
05/20/2016
Excerpt:
ALK+ NSCLC pts were randomized 1:1 either to receive ALC (300 mg b.i.d.) or CRZ (250 mg b.i.d.)...The PFS HR of ALC arm to CRZ arm was 0.34 (99.6826% CI: 0.17-0.70, stratified log-rank p<0.0001)....At J-ALEX IA, ALC demonstrated significantly prolonged PFS compared with CRZ...
DOI:
10.1200/JCO.2016.34.15_suppl.9008
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Alectinib versus chemotherapy in crizotinib-pretreated anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer: results from the phase III ALUR study

Excerpt:
ALUR (MO29750; NCT02604342) was a randomized, multicenter, open-label, phase III trial of alectinib versus chemotherapy in advanced/metastatic ALK-positive NSCLC patients...Independent Review Committee-assessed PFS was also significantly longer with alectinib [HR 0.32 (95% CI: 0.17-0.59); median PFS was 7.1 months (95% CI: 6.3-10.8) with alectinib and 1.6 months (95% CI: 1.3-4.1) with chemotherapy]. In patients with measurable baseline central nervous system (CNS) disease (alectinib, n = 24; chemotherapy, n = 16), CNS objective response rate was significantly higher with alectinib (54.2%) versus chemotherapy (0%; P < 0.001).
Secondary therapy:
docetaxel + pemetrexed
DOI:
10.1093/annonc/mdy121
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Alectinib versus crizotinib in untreated Asian patients with anaplastic lymphoma kinase-positive non-small-cell lung cancer (ALESIA): a randomised phase 3 study

Excerpt:
Investigator-assessed progression-free survival was significantly prolonged with alectinib versus crizotinib (hazard ratio [HR] 0·22, 95% CI 0·13-0·38; p<0·0001; median progression-free survival not estimable vs 11·1 months)....Our results align with ALEX, confirming the clinical benefit of 600 mg of alectinib twice per day as a first-line treatment for ALK-positive non-small-cell lung cancer.
DOI:
10.1016/S2213-2600(19)30053-0
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Alectinib versus Crizotinib in Untreated ALK-Positive Non-Small-Cell Lung Cancer

Excerpt:
The rate of investigator-assessed progression-free survival was significantly higher with alectinib than with crizotinib (12-month event-free survival rate, 68.4% [95% confidence interval (CI), 61.0 to 75.9] with alectinib vs. 48.7% [95% CI, 40.4 to 56.9] with crizotinib; hazard ratio for disease progression or death, 0.47 [95% CI, 0.34 to 0.65]; P<0.001); the median progression-free survival with alectinib was not reached. The results for independent review committee-assessed progression-free survival were consistent with those for the primary end point.
DOI:
10.1056/NEJMoa1704795
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Go to data
Title:

Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Participants Previously Treated With Platinum-Based Chemotherapy and Crizotinib

Excerpt:
...Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive. ALK positivity must have been determined by a validated fluorescence in situ hybridization (FISH) test (recommended probe, Vysis ALK Break-Apart Probe) or a validated immunohistochemistry (IHC) test (recommended antibody, clone D5F3)...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Go to data
Title:

A Study to Evaluate and Compare the Efficacy and Safety of Alectinib Versus Crizotinib and to Evaluate the Pharmacokinetics of Alectinib in Asian Participants With Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC)

Excerpt:
...Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive as assessed by the Ventana immunohistochemistry (IHC) test. Sufficient tumor tissue available to perform ALK IHC is required. Ventana IHC testing will be performed at the designated central laboratory...
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Go to data
Title:

A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants (ALEX)

Excerpt:
...Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive as assessed by the Ventana immunohistochemistry (IHC) test...
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:

NAUTIKA1 Study: Preliminary Efficacy and Safety Data with Neoadjuvant Alectinib in Patients with Stage IB-III ALK+ NSCLC

Published date:
08/08/2023
Excerpt:
In this preliminary analysis from NAUTIKA1, neoadjuvant alectinib demonstrated major pathological response and was well tolerated in patients with ALK+ NSCLC.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Comparison of Alectinib/Crizotinib Data in First-Line Therapy in Patients with Anaplastic LymphomakinasePositive Nonsmall Cell Lung Carcinoma with Poor Prognostic Features for Alectinib

Published date:
07/01/2023
Excerpt:
The data of 38 patients who were diagnosed with anaplastic lymphoma kinase-positive non small cell lung carcinoma in our clinic between 2016 and 2021…The progression rate was lower in alectinib than the crizotinib patients…
DOI:
10.5152/ThoracResPract.2023.22200
Evidence Level:
Sensitive: C3 – Early Trials
Title:

ALK Inhibitor Treatment Patterns and Outcomes in Real-World Patients with ALK-Positive Non-Small-Cell Lung Cancer: A Retrospective Cohort Study

Published date:
06/21/2023
Excerpt:
We sought to assess the overall treatment pattern characteristics, safety, and effectiveness outcomes of real-world patients with ALK-positive aNSCLC receiving ALK TKIs….alectinib was associated with favorable survival outcomes with longer time to adverse events (AE) requiring medical interventions, disease progression, and death, in the context of real-world use.
DOI:
https://doi.org/10.1007/s11523-023-00973-7
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

A Bayesian network meta-analysis of ALK inhibitor treatments in patients with ALK-positive non-small cell lung cancer

Published date:
06/19/2023
Excerpt:
The aim of the present study was to investigate the efficacy and safety of ALKis in ALK-positive NSCLC….Moreover, alectinib was significantly more effective than crizotinib (1.54, 1.02 to 2.5) in achieving the best ORR.
DOI:
https://doi.org/10.1002/cam4.6241
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

A real-world study of ALK fusion detection, treatment patterns, and survival outcomes of patients with advanced non–small-cell lung cancer (aNSCLC) in Brazil.

Published date:
05/25/2023
Excerpt:
Out of 100 ALK-positive aNSCLC patients treated with ALK TKIs, median age was 60 years and 62% were female...median Overall Survival (mOS) from start of first ALK TKI was 28 months (CI95% 18-NR). In first line, exposure to alectinib was associated with numerically higher mOS (36 months) when compared to crizotinib (18 months, HR = 0.58, CI95% 0.2-1.6).
DOI:
10.1200/JCO.2023.41.16_suppl.e18655
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Alectinib for treating patients with metastatic ALK-positive NSCLC: systematic review and network metanalysis

Published date:
05/25/2023
Excerpt:
To compare the efficacy and safety of alectinib with other ALK inhibitors in treating patients with metastatic or locally advanced ALK-positive NSCLC....Subgroup analysis by brain metastasis at baseline showed the superiority of alectinib over crizotinib and a similar effect compared with second-and third-generation inhibitors.
DOI:
https://doi.org/10.2217/lmt-2022-0018
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Efficacy and safety study with alectinib in advanced ALK-positive non-small-cell lung cancer.

Published date:
05/25/2023
Excerpt:
Observational and descriptive study of patients with advanced NSCLC and ALK+ treated with alectinib in the period 2019-2022….The ORR was 57.2%. Complete response ocurred in 28.6% of patients. The median response to treatment was 16 months and the median PFS was 16 months.
DOI:
10.1200/JCO.2023.41.16_suppl.e21153
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Explore ALK: Alectinib activity in patients with ALK+ metastatic non-small cell lung cancer—A national real world analysis (GFPC 03-2019).

Published date:
05/25/2023
Excerpt:
All ALK+ advanced NSCLC pts initiating alectinib…The best response was complete (CR), partial (PR) and stable (SD) in 21%, 58% and 17%.
DOI:
10.1200/JCO.2023.41.16_suppl.9092
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Efficacy and safety of dose-escalated alectinib in patients with metastatic ALK-positive NSCLC and CNS relapse on standard dose alectinib.

Published date:
05/25/2023
Excerpt:
In this retrospective study, pts were eligible if they had advanced ALK+ NSCLC with CNS relapse on standard dose alectinib (600 mg twice daily) and subsequently received dose-escalated alectinib (900 mg twice daily)....CNS disease control rate (DCR) was 92.0% (95% CI, 74.0-99.0), with median CNS duration of response (DoR) of 5.3 mos (95% CI, 3.4-8.3) and median CNS PFS of 7.1 mos (95% CI, 4.4-13.7)....Dose intensification of alectinib demonstrated meaningful efficacy and tolerability in pts with metastatic ALK+ NSCLC who had experienced CNS disease relapse on standard dose alectinib...
DOI:
10.1200/JCO.2023.41.16_suppl.e21079
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Real-World Comparative Effectiveness of First-Line Alectinib Versus Crizotinib in Patients With Advanced ALK-Positive NSCLC With or Without Baseline Central Nervous System Metastases

Published date:
02/23/2023
Excerpt:
Adults with advanced ALK-positive NSCLC who received first-line alectinib (from December 11, 2015) or crizotinib (from January 1, 2014) were included from a real-world database…rwPFS (weighted hazard ratio [wHR] = 0.46, 95% confidence interval [CI]: 0.33-0.65) and real-world overall survival (wHR = 0.46, 95% CI: 0.31-0.69) were significantly improved with alectinib versus crizotinib....Outcomes were significantly improved with first-line alectinib versus crizotinib in patients with advanced ALK-positive NSCLC in the U.S. real-world setting.
DOI:
10.1016/j.jtocrr.2023.100483
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Real-World Treatment and Outcomes of ALK-Positive Metastatic Non-Small Cell Lung Cancer in a Southeast Asian Country

Published date:
01/13/2023
Excerpt:
This retrospective study examined data of patients with ALK-positive NSCLC from 18 major hospitals….Crizotinib was the most commonly prescribed ALK inhibitor, followed by alectinib and ceritinib....Patients who received ALK inhibitors as first-line therapy had significantly longer TOT (median of 11 months for first-generation inhibitors, not reached for second-generation inhibitors at the time of analysis) compared to chemotherapy (median of 2 months; P<0.01)....Patients on ALK inhibitors had longer median OS and significantly longer TOT compared to chemotherapy, suggesting long-term benefit.
DOI:
10.2147/CMAR.S393729
Evidence Level:
Sensitive: C3 – Early Trials
Title:

EP08.02-131 - Alectinib after Crizotinib Failure in Patients with Advanced ALK‑Positive NSCLC: Results from the Spanish Early Access Program

Published date:
07/12/2022
Excerpt:
This multicentre retrospective study was conducted to analyse the clinical characteristics, treatment approaches, associated toxicities and efficacy outcomes of alectinib in 120 patients with advanced ALK+ NSCLC...After a median duration of alectinib treatment of 9.6 months, the objective response rate (ORR) was 54.5%, disease control rate (DCR) was 80%, median progression-free survival (PFS) was 9.4 months and median overall survival (OS) was 24.1 months.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

EP02.04-005 - Phase II NAUTIKA1 Study of Targeted Therapies in Stage II-III NSCLC: Preliminary Data of Neoadjuvant Alectinib for ALK+ NSCLC

Published date:
07/12/2022
Excerpt:
The first five patients with ALK+ NSCLC who have undergone neoadjuvant treatment and surgery were included in this analysis (data as of 22 February 2022). All patients completed at least 8 weeks of neoadjuvant treatment (median treatment duration: 8.14 weeks [range: 8.0-8.7]), had surgery during the defined protocol window (Day 57 [+10 days]), and had a complete resection (R0 resection rate: 100%) without delays or major complications....In this preliminary analysis from the ALK+ cohort of NAUTIKA1, alectinib was well tolerated in patients with ALK+ NSCLC and is considered feasible for neoadjuvant treatment.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Real-world data on efficacy and safety of first-line alectinib treatment in advanced-stage, ALK-positive non-small-cell lung cancer patients: a Turkish Oncology Group study

Published date:
06/23/2022
Excerpt:
This retrospective trial included advanced-stage, ALK-positive non-small-cell lung cancer patients who were treated with first-line alectinib….A total of 274 patients (n = 177 for treatment-naive patients) were enrolled in the study. The median progression-free survival was 26 and 28.8 months for all patients and the treatment-naive group, respectively.
DOI:
10.2217/fon-2022-0083
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Alectinib versus crizotinib in ALK-positive advanced non-small cell lung cancer and comparison of next-generation TKIs after crizotinib failure: Real-world evidence

Published date:
05/26/2022
Excerpt:
Our results revealed alectinib had better PFS and higher intracranial efficacy compared to crizotinib in ALK-positive NSCLC…
DOI:
https://doi.org/10.1002/cam4.4834
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Efficacy and prognosis of sequential 2G ALK-TKI in ALK-positive advanced NSCLC after crizotinib resistance: A real-world single-center research.

Published date:
05/26/2022
Excerpt:
We retrospectively analyzed the treatment history of 104 patients with ALK[+] NSCLC....In particular, the ORR of Alectinib and Brigatinib was significantly higher than that of Ceritinib and Ensartinib (P < 0.000), while the mPFS of Alectinib was significantly better than Ensartinib (P = 0.029)....For patients with CNS metastases, treatment with Alectinib and Brigatinib results in higher ORR and PFS.
DOI:
10.1200/JCO.2022.40.16_suppl.e21075
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Alectinib Together with Intracranial Therapies Improved Survival Outcomes in Untreated ALK-Positive Patients with Non-Small-Cell Lung Cancer and Symptomatic and Synchronic Brain Metastases: A Retrospective Study

Published date:
12/30/2021
Excerpt:
Median overall progression-free survival (PFS) was 32.8 months (95% CI 24.4– 41.2 months) in patients treated with alectinib and 8.0 months (95% CI 7.3– 8.7 months) in patients treated with crizotinib….Compared with crizotinib, alectinib showed superior efficacy and lower toxicity in the treatment of ALK-positive patients with NSCLC and symptomatic and synchronic brain metastases.
DOI:
https://doi.org/10.2147/OTT.S345439
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Crizotinib versus Alectinib for the Treatment of ALK-Positive Non-Small Cell Lung Cancer: A Systematic Review and Meta-Analysis

Published date:
12/14/2021
Excerpt:
Compared with crizotinib, alectinib exhibited superior efficacy in PFS (HR [hazard ratio]: 0.35, [0.25-0.49], p < 0.00001), OS (HR: 0.66, [0.47-0.92], p = 0.02)...In both antitumor efficacy and safety, alectinib appears to be superior to crizotinib for the treatment of ALK-positive NSCLC.
DOI:
10.1159/000521452
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Clinical outcome, long-term survival and tolerability of sequential therapy of first-line crizotinib followed by alectinib in advanced ALK+NSCLC: A multicenter retrospective analysis in China

Published date:
12/01/2021
Excerpt:
Data of patients diagnosed with advanced ALK+ NSCLC treated with first-line crizotinib sequential therapy followed by alectinib (no intermittent systemic therapy was allowed between the two ALK-TKIs) were collected in six hospitals in China....Efficacy during treatment with alectinib...All patients included in the study had at least one radiological evaluation, and ORR in the overall population was 47.5% (2CR + 27PR) (Table 6). A radiological response was found in 28 patients (60.9%, 1CR + 27PR) with target lesions. Median maximum tumor shrinkage rate was 39% (Figure 1c) as over 30% of patients with measurable lesions were found to have tumor reduction of over 50% (Figure 1d)....Sequential therapy with first-line crizotinib followed by alectinib demonstrated long-term benefits.
DOI:
https://doi.org/10.1111/1759-7714.14232
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Clinical efficacy and safety of crizotinib and alectinib in ALK-positive non-small cell lung cancer treatment and predictive value of CEA and CA125 for treatment efficacy

Published date:
11/15/2021
Excerpt:
A total of 120 patients with ALK-positive NSCLC were enrolled and randomly assigned to receive crizotinib treatment (54 patients, the control group) or alectinib treatment (66 patients, the research group)….Alectinib was clinically more efficacious and safer than crizotinib for ALK-positive NSCLC treatment.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Assessment of Alectinib vs Ceritinib in ALK-Positive Non-Small Cell Lung Cancer in Phase 2 Trials and in Real-world Data

Published date:
10/01/2021
Excerpt:
Compared with ceritinib RWD, alectinib-exposed patients had significantly longer OS in alectinib trials (adjusted hazard ratio [HR], 0.59; 95% CI, 0.44-0.75; P < .001) and alectinib RWD (HR, 0.46; 95% CI, 0.29-0.63; P < .001) after adjustment for baseline confounders....Alectinib exposure was associated with longer OS compared with ceritinib in patients with ALK-positive NSCLC...
DOI:
10.1001/jamanetworkopen.2021.26306
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

1201P - Real-world comparative effectiveness of 1L alectinib (ALC) vs crizotinib (CRZ) in patients (pts) with ALK+ advanced NSCLC with or without baseline CNS metastases (mets)

Published date:
09/13/2021
Excerpt:
Adult pts with advanced ALK+ NSCLC who received 1L ALC (from 11 Dec 2015) or CRZ (from 1 Jan 2014) were included...In the RWD cohort, rwPFS and rwOS were significantly improved with ALC vs CRZ (Table)....Outcomes were significantly improved with 1L ALC vs CRZ in pts with advanced ALK+ NSCLC in the real-world setting.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

NSCLC Patients With ALK Gene Rearrangement – Croatian Experience

Published date:
08/18/2021
Excerpt:
...mPFS2 for alectinib is 12 months (95%CI 2,3 – 21,6)….treatment with alectinib in the first line gives better survival benefit than earlier generation ALK TKIs.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Effect of alectinib versus crizotinib on progression-free survival, central nervous system efficacy and adverse events in ALK-positive non-small cell lung cancer: a systematic review and meta-analysis

Published date:
06/08/2021
Excerpt:
This study aims to evaluate the different efficacies of alectinib and crizotinib on progression-free survival (PFS), central nervous system (CNS) progression and adverse events (AEs) in NSCLC patients with ALK-positive….Alectinib showed significant PFS superiority over crizotinib. The pooled HR =0.41 (95% CI: 0.29-0.53) indicated that the alectinib therapy group did have significantly longer PFS than that of the crizotinib group.
DOI:
10.21037/apm-19-643
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Comparison of Clinical Efficacy of Alectinib Versus Crizotinib in ALK-Positive Non-Small Cell Lung Cancer: A Meta-Analysis

Published date:
06/02/2021
Excerpt:
Studies about the efficacy of alectinib versus crizotinib in the treatment of ALK-positive non-small cell lung cancer...The results of meta-analysis showed that: the overall response rate [OR = 2.07, 95% CI (1.41, 3.06), P = 0.0002], the progression free survival [HR = 0.34, 95% CI (0.21, 0.55), P <0.0001], the partial response [OR = 1.71, 95% CI (1.19, 2.46), P = 0.003], P = 0.001], in alectinib group were higher than that of crizotinib group.
DOI:
10.3389/fonc.2021.646526
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

A retrospective study of alectinib versus ceritinib in patients with advanced non–small-cell lung cancer of anaplastic lymphoma kinase fusion in whom crizotinib treatment failed

Published date:
03/24/2021
Excerpt:
Of the 65 patients with ALK-positve NSCLC who underwent treatment failure of crizotinib, 43 (66.2%) received alectinib and 22 (33.8%) received ceritinib as the subsequent treatment….Patients receiving alectinib treatment, compared to ceritinib, showed a similar 12-month PFS rate (61.0% [95% confidence interval, 47.1 to 78.9%] vs. 54.5% [95% CI, 37.3 to 79.9%]); HR for disease progression or death, 0.61 (95% CI, 0.31–1.17; p = 0.135) and median PFS (20.1 vs. 13.9 months; log-rank test p = 0.100, Fig. 1a) than those receiving ceritinib treatment....A numerically higher response rate was noted in the patients who received alectinib treatment (73.2 vs. 50.0%, p = 0.096; Table 2).
DOI:
10.1186/s12885-021-08005-1
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

155P - Predictors of Treatment Response in ALK-Positive Metastatic Non-Small Cell Lung Cancer

Published date:
03/17/2021
Excerpt:
We evaluated the data of ALK-positive metastatic NSCLC patients...Patients had received alectinib (53%), crizotinib (44.1%), and ceritinib (2.9%) as ALK inhibitor. The response ratio (complete and partial) was 66.2%.
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

154P - Intracranial efficacy of Alectinib in ALK-positive NSCLC patients with CNS metastases——A multicenter retrospective study

Published date:
03/17/2021
Excerpt:
In this retrospective study, ALK+ NSCLC patients...intracranial overall response rate(ic-ORR) was 82% (9/11), 76.5% (13/17), 43% (3/7) in each cohort….Our results indicated that Alectinib showed substantial intracranial activity in ALK-positive patients...
Evidence Level:
Sensitive: C3 – Early Trials
Title:

P84.15 Alectinib in Patients with ALK-Positive Advanced Non-Small Cell Lung Cancer as First-Line or Sequential Treatment in China

Published date:
01/12/2021
Excerpt:
...patients with ALK-positive NSCLC initiating alectinib(600 mg twice daily)...The ORR was 89.7%(35/39) and 2 patients had a complete response. Among 23 patients with measurable CNS lesions at baseline, a CNS response occurred in 22 of 23 patients (95.6%);4 patients had a complete CNS response....study confirms the efficacy and safety of alectinib in real-world advanced ALK+ NSCLC...
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Later-Line Treatment with Lorlatinib in ALK- and ROS1-Rearrangement-Positive NSCLC: A Retrospective, Multicenter Analysis

Published date:
11/07/2020
Excerpt:
ALK-positive patients showed a response rate of 43.2%, while 85.7% percent of the ROS1-positive patients were considered responders. Median overall survival from lorlatinib initiation was 10.2 and 20.0 months for the ALK- and ROS1-positive groups, respectively.
DOI:
10.3390/ph13110371
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Real-World Treatment Patterns and Progression-Free Survival Associated with Anaplastic Lymphoma Kinase (ALK) Tyrosine Kinase Inhibitor Therapies for ALK+ Non-Small Cell Lung Cancer

Published date:
06/03/2020
Excerpt:
Median rwPFS in patients with advanced ALK+ NSCLC was < 8 months for first- and second-line ALK TKI therapy and was even shorter in patients with brain metastasis, highlighting the need for more effective treatments in this patient population.
DOI:
10.1634/theoncologist.2020-0011
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Efficacy and safety of alectinib in ALK-positive non-small cell lung cancer and blood markers for prognosis and efficacy: a retrospective cohort study

Excerpt:
This study assessed the efficacy of alectinib in patients with ALK-positive NSCLC and analyzed the prognostic factors….the median PFS of patients undergoing second-line treatment was 15.0 months [95% confidence interval (CI): 0.00-32.23].
DOI:
10.21037/tlcr-22-857
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Alectinib in Crizotinib-Refractory ALK-Rearranged Non-Small-Cell Lung Cancer: A Phase II Global Study

Excerpt:
Alectinib is highly active and well tolerated in patients with advanced, crizotinib-refractory ALK-positive NSCLC, including those with CNS metastases.
DOI:
10.1200/JCO.2015.63.9443
Evidence Level:
Sensitive: C4 – Case Studies
Title:

Pathological complete response to neoadjuvant alectinib in unresectable anaplastic lymphoma kinase positive non-small cell lung cancer: A case report

Published date:
08/05/2023
Excerpt:
A 41-year-old man was pathologically diagnosed with locally advanced ALK-positive stage IIIB NSCLC. Alectinib was prescribed to induce tumor downstaging and facilitate the subsequent surgical resection. The tumor was successfully downstaged and pathological complete response was achieved.
DOI:
10.12998/wjcc.v11.i22.5322
Evidence Level:
Sensitive: C4 – Case Studies
Title:

Enteral administration of alectinib for ALK-positive non-small cell lung cancer in an elderly patient

Published date:
10/29/2021
Excerpt:
We hereby report the case of a 90-year-old patient with anaplasic lymphoma kinase-rearranged lung cancer...alectinib was administered by percutaneous gastrostomy….Total tumor regression was 28%, 37%, and 60% compared with the first baseline CT-scan after 1, 3, and 6 months of treatment respectively...
DOI:
10.1097/MD.0000000000027611
Evidence Level:
Sensitive: C4 – Case Studies
Title:

Alectinib Treatment of ALK Positive Non Small Cell Lung Cancer Patients with Brain Metastases: Our Clinical Experience

Published date:
09/01/2020
Excerpt:
Patient 1 was a 46-year-old woman diagnosed with non-small cell lung cancer with an echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase fusion gene (ALK+)….Alectinib was initiated as a second line therapy,...Good response was consequently achieved, characterized with improved overall performance and without significant adverse events.
DOI:
10.2478/prilozi-2020-0030