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- Xalkori (crizotinib) / Pfizer, Zykadia (ceritinib) / Novartis, Alecensa (alectinib) / Roche
Real-world data on treatment outcome of ALK positive non-small cell lung cancer from an Indian multi-centric cancer registry (Exhibition / Poster Area) - Oct 9, 2022 - Abstract #ESMOAsia2022ESMO_Asia_875;
Patients who received ALKi in second or later lines fared much better in comparison to chemotherapy. Use of ALKi in any lines of therapy resulted in significantly prolonged OS.
- Alecensa (alectinib) / Roche
Cost-effectiveness of alectinib compared with chemotherapy in first-line treatment for anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer in Thailand (Exhibition / Poster Area) - Oct 9, 2022 - Abstract #ESMOAsia2022ESMO_Asia_811;
Alectinib has been a standard of care in many settings where the treatment is demonstrated as a cost-effective option. Alectinib for treating Thai patients exceeds the current WTP threshold and it would result in limited access to this treatment.
- | Alecensa (alectinib) / Roche
Journal: Acute kidney injury and long-term renal effects of alectinib in anaplastic lymphoma kinase-positive non-small cell lung carcinoma: a case report. (Pubmed Central) - Oct 7, 2022
Adverse acute renal effects of alectinib may be prevented by avoiding other medication influencing renal hemodynamics, in particular nonsteroidal anti-inflammatory drugs. Without these co-medications, alectinib could be reintroduced in our patient.
- | Journal: Prediction of Resistance Mutations Against Upcoming Anaplastic Lymphoma Kinase Inhibitors. (Pubmed Central) - Oct 7, 2022
When this system was applied to repotrectinib and ensartinib, the results suggested that these drugs can be used for the second-line treatment of ALK-positive NSCLC. Predicting resistance mutations against TKIs will provide useful information to aid in the development of effective therapeutic strategies.
- ||||| Lorbrena (lorlatinib) / Pfizer, Alunbrig (brigatinib) / Takeda, Alecensa (alectinib) / Roche
Clinical, Adverse events: #LungSummit22 Great overview of the ALK space in nsclc by Sze Wei Chan 🇿🇦 where she highlights the critical questions: - intracranial efficacy - 1L Alectinib v brigatinib v lorlatinib - managing neurocog side effects of lorlatinib #LCSM @OncoAlert (Twitter) - Oct 7, 2022
- | Ensacove (ensartinib) / Xcovery, Alecensa (alectinib) / Roche
Journal: A Case of Advanced Lung Squamous Cell Carcinoma with CLIP1-ALK Fusion Gene (Pubmed Central) - Oct 6, 2022
Aletinib was effective for this patient but the patients died on September 30, 2021. This is a report of lung squamous cell carcinoma patients with CLIP1-ALK fusion gene treated with ALK inhibitors..
- | Alecensa (alectinib) / Roche
Journal: Inhibiting ALK-TOPK signaling pathway promotes cell apoptosis of ALK-positive NSCLC. (Pubmed Central) - Oct 5, 2022
Our findings reveal a novel ALK-TOPK signaling pathway in ALK-positive NSCLC. The combination of alectinib and HI-032 might be a promising therapeutic strategy for improving the sensitivity of ALK-positive NSCLC to targeted therapy.
- || Biomarker, Trial primary completion date: NAUTIKA1: A Study of Multiple Therapies in Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer (clinicaltrials.gov) - Oct 5, 2022
P2, N=80, Recruiting, Sponsor: Genentech, Inc.
The combination of alectinib and HI-032 might be a promising therapeutic strategy for improving the sensitivity of ALK-positive NSCLC to targeted therapy. Trial primary completion date: Mar 2023 --> Mar 2024
- | Journal: Therapy for Stage IV Non-Small-Cell Lung Cancer With Driver Alterations: ASCO Living Guideline. (Pubmed Central) - Oct 1, 2022
For patients with a RET rearrangement, a PS of 0-2, and previously untreated NSCLC, clinicians may offer selpercatinib or pralsetinib. In second line, for patients with a RET rearrangement who have not received RET-targeted therapy, clinicians may offer selpercatinib or pralsetinib.Additional information is available at www.asco.org/thoracic-cancer-guidelines.
- Alecensa (alectinib) / Roche
Durable complete response to Alectinib in a second line setting in metastatic ALK+ve NSCLC patient with poor PS with initial NG tube administration (Summit 2) - Oct 1, 2022 - Abstract #ESMOAsia2022ESMO_Asia_395;
On follow up in March 2022, PET CT and MRI brain confirmed ongoing complete response at more than 3 years of follow up with patient doing well and carrying out activities of daily living independently. No significant toxicity nor dose delay were noted.
- Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
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 (Hall 406) - Oct 1, 2022 - Abstract #ESMOAsia2022ESMO_Asia_280;
P3
ALC had a favourable safety profile vs CRZ despite longer treatment duration (42.3 vs 12.6 m), with fewer Grade 3–5 AEs (48 vs 55%), serious AEs (28 vs 29%) or AEs leading to treatment discontinuation (11 vs 15%). Conclusions 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.
- Xalkori (crizotinib) / Pfizer, Alunbrig (brigatinib) / Takeda, Alecensa (alectinib) / Roche
ALTA-3: A randomized trial of brigatinib (BRG) vs alectinib (ALC) in crizotinib (CRZ)-refractory advanced ALK+ NSCLC (Hall 406) - Oct 1, 2022 - Abstract #ESMOAsia2022ESMO_Asia_277;
P3
Conclusions At the IA, BIRC PFS was numerically similar between arms. No new safety findings were observed, with safety profiles consistent with known BRG and ALC profiles.
- | Journal: Investigation of cell signalings and therapeutic targets in PTPRK-RSPO3 fusion-positive colorectal cancer. (Pubmed Central) - Sep 29, 2022
Among these pathways, the most altered cancer genes (ALK, ACSL3, AXIN, MYC, TP53, GNAQ, ACVR2A, and FAS) specific for P:R fusion and involved in multiple cancer pathways were considered to have a key role in P:R fusion-positive CRC. Based on the drug-target network analysis, crizotinib, alectinib, lorlatinib, brigatinib, ceritinib, erdafitinib, infigratinib and pemigatinib were selected as putative therapeutic candidates, since they were already used in routine clinical practice in other cancer types and target genes of the drugs were involved in multiple cancer-pathways.
- || Retrospective data, Review, Journal: ALK inhibitors in ALK-rearranged non-small cell lung cancer with and without brain metastases: systematic review and network meta-analysis. (Pubmed Central) - Sep 28, 2022
The limited OS follow-up and inadequate sample sizes might contribute to having no statistically significant difference in OS of lorlatinib versus crizotinib. More high-quality and longer follow-up RCTs are warranted to prove our findings.
- Next-generation sequencing (NGS) for identifying actionable molecular alterations in newly diagnosed and recurrent IDHwt-glioblastoma (GBM) patients: a large mono institutional experience (West/Central Hall) - Sep 28, 2022 - Abstract #SNO2022SNO_316;
All patients received radiotherapy and/or temozolomide as first line therapy...To date, 10% of patients received a personalized treatment as compassionate use, off-label use or in clinical trials (9 Dabrafenib/Trametinib, 8 Alpelisib, 3 Erdafitinib, 2 Ipatasertib, 1 Alectinib, 1 Capmatinib, 1 Palbociclib, 1 Entrectinib, 1 Pamiparib)...The activity analysis is ongoing. However, the incidence of actionable molecular alterations may differ between diagnosis and recurrent GBM samples.
- Alecensa (alectinib) / Roche
Genomic alterations in ALK fusion-positive non-small cell lung cancer (NSCLC) patients with brain metastases (West/Central Hall) - Sep 28, 2022 - Abstract #SNO2022SNO_302;
This study is the first analysis of CNS specific outcomes with detailed genomic annotation for ALK+ NSCLC patients who received definitive alectinib for BM. Further investigation into the role of CNS-penetrant TKIs and the genomic alterations predictive of CNS failure are needed.
- Alecensa (alectinib) / Roche
Genomic alterations in ALK fusion-positive non-small cell lung cancer (NSCLC) patients with brain metastases (West/Central Hall) - Sep 28, 2022 - Abstract #SNO2022SNO_244;
This study is the first analysis of CNS specific outcomes with detailed genomic annotation for ALK+ NSCLC patients who received definitive alectinib for BM. Further investigation into the role of CNS-penetrant TKIs and the genomic alterations predictive of CNS failure are needed.
- Alecensa (alectinib) / Roche
SAFETY AND PHARMACOKINETICS OF ALECTINIB FOR JAPANESE PEDIATRIC PATIENTS WITH RELAPSED/REFRACTORY MALIGNANT SOLID TUMORS OR MALIGNANT LYMPHOMA (NCCH1708): A SINGLE-CENTER PHASE I TRIAL () - Sep 25, 2022 - Abstract #SIOP2022SIOP_694;
The RP2D determined in this trial was 150, 300, 450, and 600 mg/day for patients <15, ≥15 and <25, ≥25 and <35, and ≥35 kg, respectively. After this trial, enrollment of pediatric patients began in an ongoing phase 2 study with alectinib for patients with solid tumors with ALK alteration identified via next generation gene sequencing.
- ||| Lorbrena (lorlatinib) / Pfizer, NVL-655 / Nuvalent, Alecensa (alectinib) / Roche
Armed with slides now, Dr. @JessicaJLinMD discusses #ALK resistance particularly in relation to lorlatinib. Encouraging data from new TKIs like NVL-655 (ALKOVE-1) and note that post lorlatinib, some patients did respond to alectinib (preclinical data in ALK L1256F). #NACLC22 (Twitter) - Sep 24, 2022
- | Alecensa (alectinib) / Roche
Journal: Case Report of CCDC149-ALK fusion: a novel genetic alteration and a clinically relevant target in metastatic papillary thyroid carcinoma. (Pubmed Central) - Sep 24, 2022
The patient was started on alectinib, a second-generation ALK inhibitor...Our case highlights the role of ALK fusions in thyroid cancer and highlights its clinical significance in PTC. We recommend deep mutational sequencing in BRAFV600E-negative, RAIR PTC to identify targetable genetic alterations, including gene fusions, that may result in dramatic therapeutic benefits.
- | Alecensa (alectinib) / Roche
Journal: Lung adenocarcinoma with EGFR 19Del and an ALK rearrangement benefits from alectinib instead of an EGFR-TKI: A case report. (Pubmed Central) - Sep 20, 2022
Our results may indicate differential sensitivities to TKIs in patients harboring an EGFR mutation and an ALK rearrangement. Our patient's response to alectinib, instead of to EGFR-TKIs, may lead to an expanded list of alectinib beneficiaries who have rare gene co-alterations in lung adenocarcinoma.
- || Lorbrena (lorlatinib) / Pfizer, Alunbrig (brigatinib) / Takeda, Alecensa (alectinib) / Roche
It's a fine way to go, IMO. I'd just be a bit more concerned about progression and clin decline on beigatinib after alectinib than lorlatinib, but brigatinib has documented activity here as well. (Twitter) - Sep 20, 2022
- || Lorbrena (lorlatinib) / Pfizer, Alunbrig (brigatinib) / Takeda, Alecensa (alectinib) / Roche
What do you think about the sequence alectinib-brigatinib-lorlatinib? (Twitter) - Sep 20, 2022
- ||| Lorbrena (lorlatinib) / Pfizer, Alecensa (alectinib) / Roche
Clinical: Yes. Agree lorlatinib isn't easy (& can have prohibitive toxicity), but prospectively, I'd favor lorlatinib at least to try in just about every ALK+ patient who develops acquired resistance on alectinib. (Twitter) - Sep 19, 2022
- ||| Enrollment change, Trial completion date, Trial primary completion date, Metastases: The Drug Rediscovery Protocol (DRUP Trial) (clinicaltrials.gov) - Sep 19, 2022
P2, N=1550, Recruiting, Sponsor: The Netherlands Cancer Institute
Our patient's response to alectinib, instead of to EGFR-TKIs, may lead to an expanded list of alectinib beneficiaries who have rare gene co-alterations in lung adenocarcinoma. N=950 --> 1550 | Trial completion date: Dec 2022 --> Dec 2027 | Trial primary completion date: Aug 2022 --> Sep 2027
- | Zykadia (ceritinib) / Novartis, Alunbrig (brigatinib) / Takeda, Alecensa (alectinib) / Roche
Journal: Efficacy of Brigatinib in Patients With Advanced Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer Who Progressed on Alectinib or Ceritinib: ALTA-2 Study. (Pubmed Central) - Sep 14, 2022
P2
In ALTA-2, brigatinib demonstrated limited activity in patients with ALK+ NSCLC post-ceritinib or post-alectinib therapy. Median PFS was longer with brigatinib in patients without baseline detectable plasma ALK fusion.
- Genotypic Characteristics and Resistance Mutations in Advanced ALK+ NSCLC: The ALK-PATHFINDER Study (Ballroom FGH) - Sep 14, 2022 - Abstract #IASLCNACLC2022IASLC_NACLC_88;
Currently, 20 patients with blood sample collected have been enrolled. The recruitment is expected to be completed by September 2023.
- Alecensa (alectinib) / Roche
ALK-rearranged lung cancer and uncomplicated pregnancies on Alectinib: dream o reality? (ePoster kiosks (Exhibition area)) - Sep 12, 2022 - Abstract #ESGO2022ESGO_1145;
These cases, albeit only two, reveals that Alectinib during pregnancy is not necessarily associated with detectable changes in the embrio-fetal development. For the time, fertile patient treated with this new drugs must be recommended for contraception, but in case of desire of motherhood or ongoing pregnancy a multidisciplinary team should comfort the patient in making choices: a well-informed patient can choose consciously.
- | Lorbrena (lorlatinib) / Pfizer
Journal: Pan-HER inhibitors overcome lorlatinib resistance caused by NRG1/HER3 activation in ALK-rearranged lung cancer. (Pubmed Central) - Sep 12, 2022
Pharmacological inhibition of HER3 with pan-HER inhibitors or genetic knockdown of HER3 with siRNA resensitized H3122LR and A925LLR cells to lorlatinib in vitro, indicating that H3122LR and A925LLR acquired resistance by NRG1/HER3 activation. These findings demonstrate that targeting NRG1/HER3 is a potential novel therapeutic option for lorlatinib-resistant ALK-rearranged lung cancer.
- | Alunbrig (brigatinib) / Takeda
Retrospective data, Journal, Real-world evidence: Real-World Efficacy and Tolerability of Brigatinib in Patients with Non-Small Cell Lung Cancer with Prior ALK-TKIs in the United States. (Pubmed Central) - Sep 10, 2022
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.
- Next-generation sequencing (NGS) for identifying actionable molecular alterations in newly diagnosed and recurrent IDHwt-glioblastoma (GBM) patients: a large mono institutional experience (Gardehalle I & II) - Sep 9, 2022 - Abstract #EANO2022EANO_560;
Potentially, a high rate of patients could receive a personalized treatment. The activity analysis is ongoing.
- ||| Enrollment closed, Tumor mutational burden, Metastases: MyTACTIC: A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response (clinicaltrials.gov) - Sep 9, 2022
P2, N=252, Active, not recruiting, Sponsor: Genentech, Inc.
The activity analysis is ongoing. Recruiting --> Active, not recruiting
- || Review, Journal: Radiation therapy and targeted therapies: Risks and opportunities (Pubmed Central) - Sep 7, 2022
Recruiting --> Active, not recruiting This review provides a point of view in the current state of knowledge, and its limitations highlight the need for more solid data in a field full of promise.
- | Adcetris (brentuximab vedotin) / Seagen, Takeda, Alecensa (alectinib) / Roche
Journal, Monotherapy, Residual disease: Successful alectinib monotherapy for residual disease after brentuximab vedotin combined chemotherapy in ALK-positive anaplastic large cell lymphoma (Pubmed Central) - Sep 7, 2022
Alectinib showed high efficacy and tolerability, though the optimal period and long-term adverse effects of administration remain unclear. Therefore, further studies are necessary.
- |||| Retevmo (selpercatinib) / Eli Lilly, Alecensa (alectinib) / Roche
Clinical: Agree very effective targeted tx don't need to be randomized v chemo, like selpercatinib/pralset for RET+ or alectinib/brigat in ALK+ NSCLC. U know it when u see it. But KRAS G12C inhibs, HER2/3 ADCs, tx w ORR ~20-30% can make an argument that a trial for OS makes sense. #LCSM (Twitter) - Sep 5, 2022
- Ensacove (ensartinib) / Xcovery, Lorbrena (lorlatinib) / Pfizer, Alecensa (alectinib) / Roche
Differentiating Ensartinib from Lorlatinib and Alectinib for first line use in an ALK+ non-small cell lung cancer preclinical model (ResCu) (Exhibition Hall) - Sep 3, 2022 - Abstract #AACRNCIEORTC2022AACR_NCI_EORTC_440;
Alectinib led to the most cross-resistance to other ALKi while lorlatinib led to the most cross-resistance to other drug classes in both backgrounds. Biomarkers of ALKi escape and cross-resistance were derived from RNA-seq, and we are currently validating these alterations against clinical samples.
- Lorbrena (lorlatinib) / Pfizer, NVL-655 / Nuvalent
Preclinical activity of NVL-655 in patient-derived models of ALK cancers, including those with lorlatinib-resistant G1202R/L1196M compound mutation (Exhibition Hall) - Sep 3, 2022 - Abstract #AACRNCIEORTC2022AACR_NCI_EORTC_354;
NVL-655 showed activity in diverse patient-derived models of ALK-positive cancers, including ones that exhibited clinical resistance to prior-generation ALK TKIs. The broad preclinical activity of NVL-655 suggests potential utility as a best-in-class therapy for ALK-positive cancer patients.
- || Review, Journal: Anti-Angiogenic Therapy in ALK Rearranged Non-Small Cell Lung Cancer (NSCLC). (Pubmed Central) - Sep 3, 2022
The role for anti-angiogenic therapy in ALK rearranged NSCLC, however, remains to be elucidated. This review will discuss the pre-clinical rationale, clinical trial evidence to date, and future directions to evaluate anti-angiogenic therapy in ALK rearranged NSCLC.
- | Alecensa (alectinib) / Roche
Journal: The percentage of ALK-positive cells and the efficacy of first-line alectinib in advanced non-small cell lung cancer: is it a novel factor for stratification? (Turkish Oncology Group Study). (Pubmed Central) - Sep 2, 2022
Our study demonstrated that the efficacy of alectinib varies significantly across patient subgroups with different percentages of ALK-positive cells. If these findings are prospectively validated, the percentage of ALK-positive cells may be used as a stratification factor in randomized trials comparing different ALK-TKIs.
- |||||| New trial, Tumor mutational burden, Metastases: KOSMOSII: KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II (clinicaltrials.gov) - Sep 2, 2022
P=N/A, N=1000, Not yet recruiting, Sponsor: Seoul National University Bundang Hospital
- A Bayesian Network Meta-Analysis of the Tyrosine Kinase Inhibitors (TKI) for ALK-Positive Advanced Non-Small Cell Lung Cancer With or Without Brain Metastasis (Virtual) - Sep 1, 2022 - Abstract #ISPOREU2022ISPOR_EU_2577;
If these findings are prospectively validated, the percentage of ALK-positive cells may be used as a stratification factor in randomized trials comparing different ALK-TKIs. Lorlatinib showed better estimates of efficacy in comparison to the first and second generation TKIs especially in PFS, with its ranking by the front, which can be considered as the best option for clinical treatment.
- Tecentriq (atezolizumab) / Roche, Alecensa (alectinib) / Roche
Distributional Cost-Effectiveness Analysis of Lung Cancer Treatments From an NHS England Perspective (Virtual) - Sep 1, 2022 - Abstract #ISPOREU2022ISPOR_EU_1888;
Key drivers in the analysis are the incremental costs and QALYs, epidemiological characteristics of the disease and the opportunity cost threshold. Guidance for building DCEAs and transparency on how HTA agencies, such as NICE, would interpret the results and incorporate them in the decision-making would be valuable.
- Lorbrena (lorlatinib) / Pfizer
Lorlatinib As a First-Line Treatment for Alk+ Advanced Non-Small Cell Lung Cancer: A Cost-Effectiveness Analysis in Spain (Virtual) - Sep 1, 2022 - Abstract #ISPOREU2022ISPOR_EU_1020;
Guidance for building DCEAs and transparency on how HTA agencies, such as NICE, would interpret the results and incorporate them in the decision-making would be valuable. Lorlatinib dominated alectinib and was a cost-effective option versus brigatinib, assuming a willingness-to-pay threshold of €25,000/QALY, for the treatment of ALK+ advanced NSCLC in Spain.
- || Keytruda (pembrolizumab) / Merck (MSD), Tagrisso (osimertinib) / AstraZeneca, Alecensa (alectinib) / Roche
If completely resected till when will you continue alectinib or Osimertinib/ pembro? (Twitter) - Sep 1, 2022
- | Alecensa (alectinib) / Roche
New P4 trial: ADAPT ALEC: Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels (clinicaltrials.gov) - Sep 1, 2022
P4, N=196, Recruiting, Sponsor: University Medical Center Groningen
- ||| Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
P3 data, Journal: Final overall survival analysis from the phase III J-ALEX study of alectinib versus crizotinib in ALK inhibitor-naïve Japanese patients with ALK-positive non-small-cell lung cancer. (Pubmed Central) - Aug 31, 2022
Final OS analysis from J-ALEX did not show superiority of alectinib to crizotinib; this result was most likely confounded by treatment crossover. Alectinib remains a standard of care for the treatment of patients with advanced ALK-positive NSCLC.
- | Lorbrena (lorlatinib) / Pfizer, Alecensa (alectinib) / Roche
Journal: Efficacy of lorlatinib after alectinib-induced interstitial lung disease in a patient with anaplastic lymphoma kinase-positive non-small cell lung cancer: a case report. (Pubmed Central) - Aug 31, 2022
Alectinib remains a standard of care for the treatment of patients with advanced ALK-positive NSCLC. Since alectinib can occasionally cause drug-induced interstitial lung disease, as in the present case, lorlatinib may be an option to continue treatment in patients without other treatment alternatives.
- | Alunbrig (brigatinib) / Takeda
Journal, HEOR: The cost-effectiveness of brigatinib in adult patients with ALK inhibitor-naive ALK-positive non-small cell lung cancer from a US perspective. (Pubmed Central) - Aug 31, 2022
Work by Source Health Economics was funded by ARIAD Pharmaceuticals, Inc. Professional medical writing assistance was provided by Phillipa White, of Source Health Economics, and funded by ARIAD Pharmaceuticals, Inc.
- | Alecensa (alectinib) / Roche
Journal: Alectinib for the treatment of pretreated RET-rearranged advanced NSCLC: Results of the ETOP ALERT-lung trial. (Pubmed Central) - Aug 30, 2022
Accrual into our trial was terminated early in response to other reports of limited activity of alectinib in patients with RET-fusion NSCLC and the emergence of more potent selective RET-inhibitors. Also in our trial, alectinib did not show the expected potential for anti-tumour activity in NSCLC.
- || Clinical, Retrospective data, Journal: Front-line treatment for advanced non-small-cell lung cancer and ALK fusion: a network meta-analysis. (Pubmed Central) - Aug 30, 2022
Lorlatinib may have advantageous PFS compared with other agents but a greater risk of severe toxicity. Second-generation inhibitors, including alectinib, brigatinib, and ensartinib, provide major efficacy with less toxicity and remain appropriate regimens in the front-line setting.