Alecensa (alectinib) News

«123 4 5 6 7 8 9 10 11 12 13...36 37 »

|||||||||| Alecensa (alectinib) / Roche
Journal: Alectinib in Early-Stage Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer: Current Evidence and Future Challenges. (Pubmed Central) - Jul 27, 2024
In resectable anaplastic lymphoma kinase-positive lung cancer, adjuvant alectinib represents the new standard of care and could soon be used in perioperative treatment.

|||||||||| Alecensa (alectinib) / Roche
Journal: Oral absorption from surfactant-based drug formulations: the impact of molecularly dissolved drug on bioavailability. (Pubmed Central) - Jul 27, 2024
In the present study, we aimed at comparing the effect of molecularly and apparently (i.e., the sum of molecularly and colloid-associated drug) dissolved drug concentrations on the oral absorption of a poorly water-soluble drug compound, Alectinib...In contrast, by using the molecularly dissolved drug (i.e., free fraction) as the model input, the predicted plasma concentration-time profiles were in excellent agreement with observed data for all formulations under both fed and fasted conditions. By combining an advanced in vitro assessment with PBBM, the present study confirmed that only the molecularly dissolved drug, and not the colloid-associated drug, is available for direct absorption.

|||||||||| Tagrisso (osimertinib) / AstraZeneca, Alecensa (alectinib) / Roche
Journal, Surgery: Tyrosine Kinase Inhibitors With and Without Up-Front Stereotactic Radiosurgery for Brain Metastases From EGFR and ALK Oncogene-Driven Non-Small Cell Lung Cancer (TURBO-NSCLC). (Pubmed Central) - Jul 26, 2024
The addition of up-front SRS to CNS-penetrant TKI improved time-to-CNS progression and local CNS control, but not OS, in patients with BM from EGFR- and ALK-driven NSCLC. Patients with larger BM (?1 cm) may benefit the most from up-front SRS.

||||||||||  Alecensa (alectinib) / Roche
Enrollment closed:  The Food-effect on Alectinib Pharmacokinetics (clinicaltrials.gov) -  Jul 24, 2024
P=N/A, N=10, Active, not recruiting,  Sponsor: The Netherlands Cancer Institute
Patients with larger BM (?1 cm) may benefit the most from up-front SRS. Enrolling by invitation --> Active, not recruiting

|||||||||| MET Fusions in NSCLC: Prevalence, Oncogenicity, and Resistance Mechanism (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2507;
Within the DFCI cohort, a MET fusion was detected after targeted therapy in other oncogene-driven NSCLC (1 case of ALK fusion-positive NSCLC after alectinib and crizotinib treatment; and 1 case of EGFR -mutant NSCLC after osimertinib treatment), suggesting the potential implication of MET fusion in conferring resistance to targeted therapy in the setting of other oncogene-driven NSCLC...The MET D1228V mutation led to resistance to type I MET TKIs (i.e. crizotinib, APL-101, capmatinib, tepotinib)...Similar to NSCLC with MET exon 14 skipping alterations, a mutation in the kinase domain of the MET fusion could conferred resistance to a MET TKI. Additionally, MET fusions were detected at resistance after targeted therapy for other oncogene-driven NSCLC, with in vitro modeling showing that it could be overcome by combinatorial treatments with TKIs.

|||||||||| Imfinzi (durvalumab) / AstraZeneca
Survival after Salvage Treatment Following Durvalumab Consolidation in Locally Advanced Non-Small Cell Lung Cancer (LA-NSCLC) (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2401;
Table 1. Treatment Category Patients (n) Median Mos from Durvalumab Start to Subsequent Therapy (IQR) Median Mos from Durvalumab End to Subsequent Therapy (IQR) Median Overall Survival from Start of Post-durvalumab Therapy, mos (IQR) Chemotherapy 349 8.0 (4.4-13.0) 1.8 (0.9-5.2) 10.8 (5.6-18.8) Chemotherapy + PD-(L)1 147 8.3 (3.9-17.7) 1.5 (0.9-7.2) 12.9 (6.0-24.2) PD-(L)1 monotherapy 114 14.2 (6.2-20.8) 3.3 (1.4-11.6) 23.8 (8.7-34.5) PD-(L)1+CTLA4 37 14.0 (8.5-21.9) 5.5 (1.7-13.2) 12.7 (4.5-20.7) Targeted Therapy 104 7.6 (5.0-13.7) 1.9 (1.0-4.9) 30.1 (9.5-NR)

|||||||||| Alunbrig (brigatinib) / Takeda, Alecensa (alectinib) / Roche
The Cumulative Incidence of Brain Metastases in US Medicare Patients with ALK+ mNSCLC Treated with Second-generation ALK TKIs (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2328;
Conclusions : In this cohort study of US patients with ALK+ NSCLC treated with second-generation ALK TKIs in the first-line setting, we found that close to 30% had BM at baseline and an additional 20% developed a new BM following second-generation ALK TKI initiation at 5 years. Future research should examine the impact of third-generation ALK TKIs on BM incidence in patients with ALK+ NSCLC.

|||||||||| Alecensa (alectinib) / Roche
Challenges in Diagnosis and Management of Epithelioid Inflammatory Myofibroblastic Sarcoma - Case Report (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2293;
Subsequently, upon approval of the medication, treatment with alectinib was undertaken on June 6, 2020, and external radiotherapy was interrupted...Accurate diagnosis and targeted therapy guided by ALK expression patterns remain crucial for managing this challenging malignancy. Further research and collaborative efforts are needed to enhance outcomes for patients affected by EIMS.

|||||||||| Lorbrena (lorlatinib) / Pfizer
A Patient-Centric, Phase II Trial of First-Line Lorlatinib&alk TKIs in China Advanced ALK+ Non-Small Cell Lung Cancer (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2211;
The RO cohort is designed to serve as comparison cohort, which will enroll 63 treatment-naive subjects who may receive crizotinib, ceritinib, alectinib, brigatinib, ensartinib, lorlatinib, etc. Real-world efficacy and safety data of ALK TKIs were collected in the same cross-section. The primary endpoint is real-world progression-free survival (rwPFS) of ALK TKIs in the first-line treatment of advanced NSCLC patients with ALK fusion.

|||||||||| OBX02-011 / Oncobix
OBX02-011, a Novel Oral ALK and EGFR Dual-target Tyrosine Kinase Inhibitor for the Treatment of Advanced NSCLC Patients (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2194;
In addition, OBX02-011 demonstrated superior inhibition compared to lorlatinib in ALK_C1156Y, G1202R, and L1196M mutations associated with clinical resistance to the first generation ALK inhibitor crizotinib and/or the second generation ALK inhibitors alectinib, brigatinib, and ceritinib...OBX02-011 also demonstrated tumor regression in the osimertinib-resistant lung cancer patient-derived xenograft model with EGFR_exon 19 deletion/T790M/C797S...In vitro cell-based assay results showed that OBX02-011 does not inhibit NTRK2 (TRKB), which causes neurological toxicity, and there were also no significant findings for OBX02-011 in the CNS safety pharmacology study. Based on these studies, a first-in-human study will be conducted in 2024 to address the current resistance mechanisms in ALK-positive or EGFR-positive NSCLC patients and prolong progression free survival.

|||||||||| Alecensa (alectinib) / Roche
Effectiveness of Alectinib in ALK Rearrangement NSCLC: Real World Data of Peru (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2178;
Alectinib demonstrated high ORR, even favorable responses in patients with CNS metastasis, which is often a challenging site of management. Median PFS and median OS were not reached, suggesting a potentially durable benefit from alectinib therapy in this patient population.

|||||||||| Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
Intrinsic ALK-TKI Resistance Due to Met-Coamplification in ALK+ NSCLC, Effectively Treated by Alectinib-crizotinib Combination (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2174;
The recognition of this mechanism of ALK-TKI resistance by FISH, especially in NGS-negative cases, should be considered before initiating 1 st line treatment. This is of clinical importance, as effective combined therapy with ALK-TKI and MET-inhibitor is feasible.

|||||||||| Alecensa (alectinib) / Roche
Patterns and Clinical Impact of Alectinib Dose Reduction in Patients with ALK-Positive Non- Small Cell Lung Cancer (NSCLC) (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2172;
There was also no significant difference in overall survival in both groups. Overall, findings from this study suggest that when dose reduction is needed, it does not appear to negatively impact patient outcomes including CNS disease control, however further studies are needed to confirm findings and to determine whether the same holds true for other ALK inhibitors.

|||||||||| Characterizing the Severity and Timing of Real-World ALK-Inhibitor Associated Weight Gain in Non-Small Cell Lung Cancer (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2170;
Future investigation of optimal prevention and management of weight gain is encouraged. Table 1: Real World Weight Gain Characteristics on ALK-TKIs Crizotinib Brigatinib Alectinib Lorlatinib p-value Mean Max Weight Gain (% baseline) [95% CI] +4.2% [1.9-6.7] +4.5% [2.3-6.6] +6.4% [4.4-8.5] +13.3% [9.3-17.4] <0.001 Mean Time to Max Weight Gain (mo) [95% CI] 20.0mo [12.4-27.6] 24.6mo [14.0-35.2] 16.0mo [11.8-20.1] 22.2mo [13.7-30.8] 0.24 Mean Max Weight Gain by 6 mo (% baseline) [95% CI] -1.4% [-4.0-1.2] +0.9% [-1.2-3.0] +3.2% [1.3-5.1] +5.8% [2.9-8.7] 0.02 % Grade 2-3 Weight Gain [% Grade 3] 11.8% [0%] 13.0% [0%] 30.2% [3.9%] 61.3% [29.0%] <0.001

|||||||||| Lorbrena (lorlatinib) / Pfizer, Alecensa (alectinib) / Roche
BMF Deficiency Leads to an Increase of Drug Tolerant Persister Cells in ALK-Positive Lung Cancer (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2166;
BMF loss has been observed in approximately 1% of NSCLC cases in the cBioportal database, but further evaluation of clinical significance is needed using pre- and post-TKI treated samples. Additionally, preclinical in vivo studies are needed to assess the efficacy and toxicity of the potential combination therapy for depleting DTP cells after ALK-TKI treatment.

|||||||||| Real-World Treatment Patterns and Effectiveness in Patients with ALK+ Advanced NSCLC Treated with 1L ALK TKIs (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2164;
Conclusions : In patients with ALK+ advanced NSCLC, 1L alectinib and 1L brigatinib had similar rwTTD and rwTTNT. These real-world findings mirror and support the Phase 3 ALTA-1L trial data demonstrating the efficacy of 1L brigatinib vs. crizotinib in patients with ALK+ advanced NSCLC.

|||||||||| Alecensa (alectinib) / Roche
Weight Gain and Metabolic Changes Associated with Alectinib Use in ALK-Positive Lung Cancer (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2163;
Conclusions : First-line alectinib in a real-world cohort is associated with >30% incidence of G1-G2 weight gain, more than 3-fold higher than previously reported in Phase 3 clinical trial results and significantly increased relative to a similar EGFR -mut cohort treated with a comparably well tolerated and highly effective TKI. Prospective evaluation of weight and potential long-term metabolic complications related to alectinib and other ALK TKIs is warranted.

|||||||||| Tagrisso (osimertinib) / AstraZeneca, Opdivo (nivolumab) / BMS, Alecensa (alectinib) / Roche
Real-World Outcomes of Patients with Resectable Early-Stage Non-Small Cell Lung Cancer Treated with Neoadjuvant Chemoimmunotherapy (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1948;
Eighteen (69%) received carboplatin/pemetrexed, 6 (23%) carboplatin/paclitaxel, and 2 (8%) carboplatin/gemcitabine for a median of 3 cycles (range 2-4)...Five (19%) received adjuvant therapy; 3 (12%) nivolumab and 2 (8%) targeted therapies (one osimertinib and one alectinib)...All patients were able to undergo surgical resection via lobectomy suggesting room for outcome improvement. Results from this study corroborate the use of neoadjuvant chemoimmunotherapy in the real-world setting.

|||||||||| Xalkori (crizotinib) / Pfizer, Qi Xinke (iruplinalkib) / Qilu Pharma
Iruplinalkib in Patients with ALK-Positive Crizotinib-Resistant NSCLC: Updated Efficacy and Safety Data from a Phase 2 Trial (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1602;
P2
The updated results provided new evidence for the use of iruplinalkib in patients with ALK-positive crizotinib-resistant advanced NSCLC. Investigator-assessed response in pts with measurable intracranial lesions and with CNS metastases Per investigator Patients with measurable intracranial lesions (n=42) Patients with central nervous system metastases (n=90) Best of response, n (%) Complete response 3 (7.1%) 0 Partial response 24 (57.1%) 50 (55.6%) Stable disease 13 (31.0%) 34 (37.8%) Progressive disease 1 (2.4%) 4 (4.4%) Not evaluable 1 (2.4%) 2 (2.2%) Objective response rate, n (%) 27 (64.3%) 50 (55.6%) 95% confidence interval 48.0% to 78.4% 44.7% to 66.0% Disease control rate, n (%) 40 (95.2%) 84 (93.3%) 95% confidence interval 83.8% to 99.4% 86.1% to 97.5% Median duration of response, months 18.69 17.25 95% confidence interval 15.01 to 20.99 10.35 to 19.48

|||||||||| Central Nervous System (CNS) Progression on CNS Penetrable ALK TKI: Real-World Practice Patterns and Patient Outcomes (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1599;
Our findings support continuing some form of TKI therapy among select patients with ALK -rearranged NSCLC who develop CNS progression on a CNS penetrable TKI. Table: Baseline and Disease Progression Characteristics Characteristic Total Patients (N=36)n (%) TKI unaltered (n=16)n (%) TKI altered (switched TKI or increased TKI dose)(n=14)n (%) TKI discontinued (n=6)n (%) p-value Baseline Characteristics Female 21 (58) 10 (63) 8 (57) 3 (50) 0.91 TKI at time of CNS progression (T0) 0.01 Alectinib 23 (64) 9 (56 12 (86) 2 (33) Brigatinib 4 (11) 0 (0) 2 (14) 2 (33) Ensartinib 6 (17) 5 (31) 0 (0) 1 (17) Lorlatinib 3 (8.3) 2 (12.5) 0 (0) 1 (17) Baseline CNS parenchymal disease 0.25 Present 31 (86) 15 (94) 12 (86) 4 (67) Absent 4 (11) 1 (6.3) 1 (7.2) 2 (33) Missing 1 (2.8) 5 (14) 1 (7.2) 0 (0) Baseline leptomeningeal disease 0.18 Present 2 (5.6) 0 (0) 2 (14) 0 (0) Absent 29 (81) 15 (94) 10 (71) 4 (67) Missing 5 (14) 1 (6.3) 2 (14) 2 (33) Number of prior systemic lung cancer treatments, including prior TKI 0.03 0 7 (19) 5 (31) 1 (7.2) 1 (17) 1-2 16 (44) 7 (44) 9 (64) 0 (0) ?3 13 (36) 4 (25) 4 (29) 5 (83) Prior stereotactic radiosurgery 14 (39) 4 (25) 9 (64) 1 (17) 0.06 Prior whole brain radiation therapy 6 (17) 1 (6.3) 5 (36) 0 (0) 0.09 Disease Progression Characteristics Leptomeningeal progression 7 (19) 0 (0) 6 (43) 1 (17) 0.01 CNS parenchymal progression 33 (92) 16 (100) 11 (79) 6 (100) 0.12 Type of CNS parenchymal progression 0.26 No CNS parenchymal progression 3 (8.3) 0 (0) 3 (21) 0 (0) New CNS parenchymal lesion(s) 13 (36) 6 (37) 4 (29) 3 (50) Growth in baseline CNS parenchymal lesion(s) 10 (28) 7 (44) 2 (14) 1 (17) Both new and growth in baseline CNS parenchymal lesions 10 (28) 3 (19) 5 (36) 2 (33) Concurrent CNS and systemic progression 18 (50) 4 (25) 8 (57) 6 (100) 0.01 Abbreviations: ALK, anaplastic lymphoma kinase; CNS, central nervous system; NSCLC, non-small cell lung cancer; TKI, tyrosine kinase inhibitor

|||||||||| Alunbrig (brigatinib) / Takeda
Real-World Outcomes of 2L ALK TKIs Following 1L Brigatinib for Patients with ALK+ NSCLC from the ALTA-1L Trial (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1598;
Introduction : In the phase III ALTA-1L trial, brigatinib showed superior efficacy vs. crizotinib in first line (1L) for anaplastic lymphoma kinase positive ( ALK +) non-small cell lung cancer (NSCLC)...Of these, 30 received a 2L ALK TKI (median follow-up, 17.0 months; median age, 57.5 years; White, 46.7%; Asian, 50.0%; female, 60.0%), including 16 (53.3%) on 2L lorlatinib and 8 (26.7%) on 2L alectinib...This study was limited by small sample size. 1 Delmonte A. Poster #38P ELCC 2024

|||||||||| Alecensa (alectinib) / Roche
Mechanisms of Resistance to First-Line vs Later-Line Alectinib in ALK Fusion-Positive Non-Small Cell Lung Cancer (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1595;
Conclusions : In this largest series of alectinib-resistant biopsies to date, on-target resistance (i.e., ALK resistance mutation) was significantly less common when alectinib was used as 1L vs 2L+ therapy, highlighting the importance of elucidating strategies to overcome off-target resistance to next-generation ALK TKI. Our findings additionally underscore the complementary role of tissue and plasma re-biopsies in delineating the resistance landscape, with tissue more likely to detect MET amplification and capable of identifying histologic transformation and plasma more likely to detect ?2 co-occurring ALK mutations.

|||||||||| Alecensa (alectinib) / Roche
Mechanisms of Resistance to First-Line vs Later-Line Alectinib in ALK Fusion-Positive Non-Small Cell Lung Cancer (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1579;
Conclusions : In this largest series of alectinib-resistant biopsies to date, on-target resistance (i.e., ALK resistance mutation) was significantly less common when alectinib was used as 1L vs 2L+ therapy, highlighting the importance of elucidating strategies to overcome off-target resistance to next-generation ALK TKI. Our findings additionally underscore the complementary role of tissue and plasma re-biopsies in delineating the resistance landscape, with tissue more likely to detect MET amplification and capable of identifying histologic transformation and plasma more likely to detect ?2 co-occurring ALK mutations.

|||||||||| Keytruda (pembrolizumab) / Merck (MSD), Tagrisso (osimertinib) / AstraZeneca, Alecensa (alectinib) / Roche
Revolutionizing Survival: The Real-World Impact of High-Cost Therapies on Advanced NSCLC (30A) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1052;
Patients were divided into 3 cohorts according to their access to high-cost drugs; A) patients who did not have access to targeted therapy or immunotherapy at all; B) patients who had access only to erlotinib and, C) patients who had access to osimertinib, alectinib or immunotherapy...Erlotinib, alectinib and pembrolizumab were used as 1L in 70.34%, 75% and 92% of patients, respectively...Conclusions : Access to standard-of-care drugs remains a challenge for Latin American NSCLC patients, affecting the choice of initial treatment. Our real-world data affirms that incorporating these high-cost medications significantly improves survival rates, thus, it is imperative to strive for expanding access to these treatments.

|||||||||| Ensacove (ensartinib) / Betta Pharma
Predictors of Long-Term Ensartinib Response from the eXalt3 Trial (20D) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_980;
Conclusions : We profiled three patients who have continued to respond to ensartinib for over 70 cycles, despite exhibiting clinically validated resistance mechanisms to other ALK inhibitors at enrollment. The REvolution, long-term evolution system, identified biomarkers which predicted response to ensartinib.

|||||||||| Lorbrena (lorlatinib) / Pfizer
Patterns of Progression with Lorlatinib and Insights into Subsequent Anticancer Therapy Efficacy in Advanced ALK+ NSCLC (20D) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_978;
P3
Best Overall Response and Objective Response Rate on First Subsequent Anticancer Therapy Study treatment Lorlatinib Crizotinib First Subsequent Therapy Any ALK TKI (n=23) a Any non-ALK TKI (n=15) b Overall (n=38) Any ALK TKI (n=101) a Any non-ALK TKI (n=8) b Overall (n=109) Objective response rate (95% CI), % c 26.1 (10.2-48.4) 20.0 (4.3-48.1) 23.7 (11.4-40.2) 17.8 (10.9-26.7) 12.5 (0.3-52.7) 17.4 (10.8-25.9) Best overall response, n (%) Complete response 2 (9) 1 (7) 3 (8) 1 (1) 0 1 (1) Partial response 4 (17) 2 (13) 6 (16) 17 (17) 1 (13) 18 (17) Stable disease 1 (4) 3 (20) 4 (11) 23 (23) 0 23 (21) Progressive disease 6 (26) 3 (20) 9 (24) 10 (10) 2 (25) 12 (11) Unknown 3 (13) 5 (33) 8 (21) 9 (9) 4 (50) 13 (12) Not reported, therapy ongoing 7 (30) 1 (7) 8 (21) 41 (41) 1 (13) 42 (39) a Includes alectinib, brigatinib, ceritinib, crizotinib, and lorlatinib. b Includes chemotherapy

|||||||||| Alecensa (alectinib) / Roche
ALINA Safety Results: Adjuvant Alectinib vs Chemotherapy in Patients with Resected ALK+ Non-Small Cell Lung Cancer (NSCLC) (20A) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_951;
P3
Conclusions : Alectinib had a manageable safety profile; coupled with the previously reported efficacy data, these results support the use of adjuvant alectinib in patients with resected, stage IB-IIIA, ALK + NSCLC. No new safety concerns were identified.

|||||||||| Alecensa (alectinib) / Roche
Neoadjuvant Alectinib in Potentially Resectable Stage III ALK-Positive NSCLC: Interim Analysis of ALNEO-GOIRC-01-2020 Phase II Trial (20BC) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_830;
P2
Conclusions : Results of the first stage interim analysis allowed to continue the accrual in order to reach the total of 33 planned patients. Neoadjuvant alectinib appeared to be safe in potentially resectable locally advanced stage III ALK-positive NSCLC patients.

|||||||||| Journal, HEOR, Real-world evidence, Real-world: Real-World Treatment Patterns and Outcomes Across Three Lines of Therapy in Patients with ALK+ NSCLC. (Pubmed Central) - Jul 22, 2024
Patients receiving third-line non-ALK-directed therapy had suboptimal outcomes on prior TKIs. Patients with longer duration of prior ALK TKI treatment appeared to benefit from third-line ALK TKIs.

|||||||||| Alecensa (alectinib) / Roche
Journal, Metastases: Symptomatic androgen deficiency and sexual dysfunctions in male patients receiving alectinib for ALK-positive (Pubmed Central) - Jul 20, 2024
Patients with longer duration of prior ALK TKI treatment appeared to benefit from third-line ALK TKIs. Symptoms of androgen deficiency should be tracked in male patients with ALK-positive ANSCLC who are receiving alectinib, and testosterone replacement should be considered, as appropriate.

|||||||||| Alecensa (alectinib) / Roche
ALINA: Exploratory biomarker analyses in patients (pts) with resected ALK+ non-small cell lung cancer (NSCLC) treated with adjuvant alectinib vs chemotherapy (chemo) (Sevilla Auditorium - Hall 2) - Jul 16, 2024 - Abstract #ESMO2024ESMO_1691;
P3
In ALINA, DFS benefit with alectinib was seen regardless of EML4-ALK variant. Pts with WT TP53 at baseline showed a trend for improved DFS with alectinib vs mutated TP53.

|||||||||| Lorbrena (lorlatinib) / Pfizer, Alecensa (alectinib) / Roche
P3 data, Review, Journal: Alectinib vs. Lorlatinib in the Front-Line Setting for ALK-Rearranged Non-Small-Cell Lung Cancer (NSCLC): A Deep Dive into the Main Differences across ALEX and CROWN Phase 3 Trials. (Pubmed Central) - Jul 13, 2024
Furthermore, the rate of permanent treatment discontinuation due to adverse events was numerically higher with alectinib (26%) than with lorlatinib (7%). In conclusion, despite the immature OS data for both drugs, the efficacy of lorlatinib appears higher than alectinib while maintaining a manageable toxicity profile.

|||||||||| Alecensa (alectinib) / Roche
Journal, Real-world evidence, Real-world, Metastases: Analysis of the resistance profile of real-world alectinib first-line therapy in patients with ALK rearrangement-positive advanced non-small cell lung cancer using organoid technology in one case of lung cancer. (Pubmed Central) - Jul 10, 2024
NGS testing of patients' blood or tissue samples after disease progression may provide insight into the etiology of alectinib resistance. Patient-sourced drug sensitivity testing of lung cancer-like organs selects drug-sensitive medications based on NGS results and provides a reference for subsequent drug therapy for patients after drug resistance, particularly those who remain ALK rearrangement-positive at baseline.

|||||||||| Alecensa (alectinib) / Roche
Journal: Solubility, pH-Solubility Profile, pH-Rate Profile, and Kinetic Stability of the Tyrosine Kinase Inhibitor, Alectinib. (Pubmed Central) - Jun 27, 2024
The optimal dissolution media for in vitro oral dosage form evaluation were determined, achieving sink conditions at pH levels of 6.8 and 4.5 with specific additives. This study enhances the existing database on ALBHCL's physicochemical properties, emphasizing the importance of pH optimization in pharmaceutical processes and providing valuable insights into its pharmaceutical application.

|||||||||| Alecensa (alectinib) / Roche
Journal: Evaluation of Solubility, Dissolution Rate, and Oral Bioavailability of ?-Cyclodextrin and Hydroxypropyl ?-Cyclodextrin as Inclusion Complexes of the Tyrosine Kinase Inhibitor, Alectinib. (Pubmed Central) - Jun 27, 2024
This study enhances the existing database on ALBHCL's physicochemical properties, emphasizing the importance of pH optimization in pharmaceutical processes and providing valuable insights into its pharmaceutical application. Pharmacokinetic profiles revealed increased Cmax (240

|||||||||| Lorbrena (lorlatinib) / Pfizer, Alunbrig (brigatinib) / Takeda, Alecensa (alectinib) / Roche
Journal: Successful intracranial response of lorlatinib after resistance with alectinib and brigatinib in patients with ALK-positive lung adenocarcinoma: Implications of CNS penetration rate of brigatinib. (Pubmed Central) - Jun 26, 2024
Taken together, we speculate that the low CNS penetration rate of brigatinib confers CNS progression. Further studies are warranted to reveal the resistance mechanism and propose a treatment strategy for CNS progression in ALK-positive patients.

|||||||||| Alecensa (alectinib) / Roche
Journal: Adjuvant alectinib improves outcomes in ALK-mutant NSCLC. (Pubmed Central) - Jun 24, 2024
Further studies are warranted to reveal the resistance mechanism and propose a treatment strategy for CNS progression in ALK-positive patients. No abstract available

|||||||||| Alecensa (alectinib) / Roche
Review, Journal, Metastases: ALK Inhibition With Alectinib for Refractory Metastatic Renal Cell Carcinoma With ALK Rearrangement: A Rare Case Report and Literature Review. (Pubmed Central) - Jun 17, 2024
No abstract available ALK-rearranged RCC refractory to several lines of treatment has a durable response when treated with alectinib.

|||||||||| Journal: Resistance to anti-EGFR through the successive and cumulative acquisition of two new oncogenic addictions: BRAF and ALK (Pubmed Central) - Jun 10, 2024
Subsequent to additional progression and given the ALK rearrangement shown on the re-biopsy, 6th-line treatment with alectinib was proposed...This exceptional case is characterized by resistance to anti-EGFR through the successive and cumulative acquisition of two new oncogene addictions. The authors underline the importance of re-biopsy at each progression, leading (if at all feasible) to yet around round of targeted therapy.

|||||||||| Preclinical, Journal: Transforming tumoroids derived from ALK-positive pulmonary adenocarcinoma to squamous cell carcinoma in vivo. (Pubmed Central) - Jun 3, 2024
The authors underline the importance of re-biopsy at each progression, leading (if at all feasible) to yet around round of targeted therapy. PDT-LUAD#119 lung tumoroids were sensitive to the ALK tyrosine kinase inhibitors (ALK TKIs) crizotinib, alectinib, entrectinib, and lorlatinib, similar to NCI-H3122 cells harboring EML4-ALK variant 1

|||||||||| Journal, HEOR, Cost-effectiveness, Cost effectiveness: Cost-Effectiveness Analysis of 6 Tyrosine Kinase Inhibitors as First-Line Treatment for ALK-Positive NSCLC in China. (Pubmed Central) - Jun 3, 2024
Under a willingness-to-pay threshold of $38?223/QALY, ceritinib and brigatinib were cost-effective compared with ensartinib, while lorlatinib and alectinib were not cost-effective when compared with ensartinib. Overall, brigatinib emerged as the most cost-effective treatment among all the options considered.

|||||||||| Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
Alectinib versus crizotinib as first-line treatment in patients with advanced ALK-mutated non-small cell lung cancer: a Chinese, real-world cohort study (PS-27; Poster board no. 17) - May 31, 2024 - Abstract #ERS2024ERS_5072;
Overall, brigatinib emerged as the most cost-effective treatment among all the options considered. Alectinib is the preferred drug for ALK mutation patients when compared to crizotinib

|||||||||| Enrollment open, Enrollment change, Trial completion date, Trial primary completion date, Metastases: ALK Tyrosine Kinase Inhibitors in ALK-rearranged Advanced Squamous Cell Carcinoma (clinicaltrials.gov) - May 31, 2024
P=N/A, N=120, Recruiting, Sponsor: Hunan Province Tumor Hospital
Alectinib is the preferred drug for ALK mutation patients when compared to crizotinib Completed --> Recruiting | N=5927 --> 120 | Trial completion date: Aug 2021 --> Aug 2027 | Trial primary completion date: Jun 2021 --> Jun 2026

|||||||||| Alunbrig (brigatinib) / Takeda
Journal: Inflammation-related molecular signatures involved in the anticancer activities of brigatinib as well as the prognosis of EML4-ALK lung adenocarcinoma patient. (Pubmed Central) - May 27, 2024
In summary, our results delineate clinical responses of sequential ALK-TKIs treatments and provide insights into the mechanisms underlying the superior effects of brigatinib in patients harboring ALKG1269A mutation and resistant towards alectinib, lorlatinib and crizotinib. The molecular signatures model based on the combination of IL6, CXCL1 and CXCL5 has the potential to predict prognosis of EML4-ALK positive NSCLC patients.

|||||||||| Alecensa (alectinib) / Roche
Lung adenocarcinoma with thyroid metastasis: a rare case (Mezzanine level of the exhibition area) - May 17, 2024 - Abstract #BAHNO2024BAHNO_92;
Conclusion There is diagnostic complexity in establishing the primary cancer in cases with unusual distribution of metastases and this case report demonstrates the fundamental role of the MDTM; correlation of clinical, radiological and cytomorphological features were key in establishing the correct diagnosis and appropriate treatment. The distinction between primary and secondary thyroid tumours is important to determine staging and treatment.

||||||||||  Alecensa (alectinib) / Roche
Trial completion date, Trial primary completion date:  A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer (clinicaltrials.gov) -  May 14, 2024
P3, N=200, Recruiting,  Sponsor: Hoffmann-La Roche
The distinction between primary and secondary thyroid tumours is important to determine staging and treatment. Trial completion date: Jun 2024 --> Jun 2026 | Trial primary completion date: Jun 2024 --> Jun 2026

|||||||||| Xalkori (crizotinib) / Pfizer, Qi Xinke (iruplinalkib) / Qilu Pharma, Alecensa (alectinib) / Roche
Journal, HEOR, Cost-effectiveness, Cost effectiveness, Metastases: The cost-effectiveness of iruplinalkib versus alectinib in anaplastic lymphoma kinase-positive crizotinib-resistant advanced non-small-cell lung cancer patients in China. (Pubmed Central) - May 3, 2024
From the PSA, iruplinalkib had a 90% probability of being cost-effective at a willingness-to-pay threshold of $37,863.56/QALY. Compared to alectinib, iruplinalkib is a cost-effective therapy for patients with ALK-positive crizotinib-resistant advanced NSCLC.

|||||||||| Real-world barriers to CAR-T access: A Canadian referral center perspective. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5003;
Our study did not capture patients not referred due to geographical considerations but highlights dismal outcomes for patients ineligible for CAR-T. Widespread access to novel therapies is awaited.

|||||||||| Alecensa (alectinib) / Roche
Health-related quality of life (HRQoL) results for adjuvant alectinib vs chemotherapy in patients with resected ALK+ non-small cell lung cancer (NSCLC): Data from ALINA. (Arie Crown Theater) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3272;
P3
With chemotherapy, HRQoL was low during treatment, but improved in the post-chemotherapy period. Together with the DFS benefit seen in ALINA, these data support alectinib as an important new adjuvant treatment for patients with resected ALK+ NSCLC.

|||||||||| Imfinzi (durvalumab) / AstraZeneca
Global retrospective study comparing consolidation ALK tyrosine kinase inhibitors (TKI) to durvalumab (durva) or observation (obs) after chemoradiation (CRT) in unresectable locally-advanced ALK+ non-small cell lung cancer (NSCLC). (S406) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3260;
Furthermore, we show a high rate of progression following CRT alone in ALK+ NSCLC. These findings underscore the need for prospective molecularly driven trials to determine the optimal consolidation therapy for unresectable ALK+ NSCLC.



	Diseases Companies Products Productz Mechanisms of Action Sites