- |||||||||| Zykadia (ceritinib) / Novartis
Journal: Ceritinib is a novel triple negative breast cancer therapeutic agent. (Pubmed Central) - Jul 1, 2022 Furthermore, we introduced a novel therapeutic combination of ceritinib and paclitaxel for AR negative or AR-low TNBCs and this combination inhibited tumor growth to a great extent. All agents used in our study are FDA-approved, and thus the proposed combination therapy will likely be useful in the clinic.
- |||||||||| Zykadia (ceritinib) / Novartis
Biomarker, Enrollment closed, Enrollment change, Combination therapy, Metastases: Ceritinib and Everolimus in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIB-IV Non-small Cell Lung Cancer (clinicaltrials.gov) - Jun 30, 2022 P1, N=37, Active, not recruiting, Trial completion date: Dec 2022 --> Apr 2023 | Trial primary completion date: Dec 2022 --> Apr 2023 Recruiting --> Active, not recruiting | N=66 --> 37
- |||||||||| Toxicity of Sequential Tyrosine Kinase Inhibitors After Immune Checkpoint Inhibitors in Advanced Non-small Cell Lung Cancer (Exhibit Hall - Hall B) - Jun 24, 2022 - Abstract #IASLCWCLC2022IASLC_WCLC_1109;
In our stage IV NSCLC population, there was no significant safety signal with sequential treatment of ICI followed by TKI; only one patient required treatment break/discontinuation due to pneumonitis. This differs from existing literature possibly because the majority of our population did not harbour a driver mutation and there were limited patients treated with crizotinib, ceritinib and osimertinib, other agents that have been associated with this safety signal.
- |||||||||| Lorbrena (lorlatinib) / Pfizer, NVL-655 / Nuvalent
Preclinical Activity of NVL-655 in a Patient-Derived NSCLC Model with Lorlatinib-Resistant ALK G1202R/T1151M Mutation (Exhibit Hall - Hall B) - Jun 24, 2022 - Abstract #IASLCWCLC2022IASLC_WCLC_1002; The potent preclinical activity of NVL-655 suggests potential clinical utility for ALK-positive patients, including those with resistant compound mutations. The MR448re PDC and xenograft are valuable additions to the ALK therapeutic research landscape where there is limited availability of patient-derived models with lorlatinib-resistant ALK compound mutations.
- |||||||||| Alunbrig (brigatinib) / Takeda, Alecensa (alectinib) / Roche
Integrated Efficacy and Safety of Brigatinib Following Alectinib Treatment in the ALTA-2 and J-ALTA Studies (Hall C7) - Jun 24, 2022 - Abstract #IASLCWCLC2022IASLC_WCLC_743; P2 Brigatinib treatment demonstrated clinically meaningful efficacy in this integrated analysis of patients with advanced or metastatic ALK+ NSCLC who progressed on prior alectinib in the ALTA-2 or J-ALTA trials. Safety results were consistent with the known profile for brigatinib, with no new safety findings observed.
- |||||||||| Xalkori (crizotinib) / Pfizer, Zykadia (ceritinib) / Novartis, Alecensa (alectinib) / Roche
A Systematic Review (SR) of Cost-effectiveness Analysis (CEA) of ALK Inhibitors (iALK) in Advance Non-small Cell Lung Cancer (NSCLC) (Exhibit Hall - Hall B) - Jun 24, 2022 - Abstract #IASLCWCLC2022IASLC_WCLC_544; Setting thresholds and negotiate drug prices should be prioritized to improve patients access to innovative This review showed how the cost-effectiveness thresholds varied among countries and provided an overview of the available cost-effectiveness findings for stakeholders. Setting thresholds and negotiate drug prices should be prioritized to improve patients access to innovative drugs, as iALK, in timely manner.
- |||||||||| Zykadia (ceritinib) / Novartis
Journal: An ascendant challenge: central nervous system metastases in ALK+ lung cancers. (Pubmed Central) - Jun 15, 2022 Central nervous system (CNS) metastases constitute a challenge for the design of ALK fusion-positive lung cancer trials. The ASCEND-7 study of ceritinib demonstrates the feasibility of broadening CNS eligibility criteria to include symptomatic brain and leptomeningeal disease and highlights design features that contemporary trials will need to incorporate.
- |||||||||| Alunbrig (brigatinib) / Takeda
Journal: Strengths and pitfalls of brigatinib in non-small cell lung cancer patients' management. (Pubmed Central) - May 24, 2022 Through a spurious exercise of an indirect comparison with other available 2G ALKi, we tent to summarize the required knowledge to properly choose the best drug at the right time. Furthermore, we reviewed available data on molecular resistance mechanisms and putative therapeutic applications in other contexts, such as ROS1+ NSCLC patients or EGFR+ ones progressing to osimertinib.
- |||||||||| Xalkori (crizotinib) / Pfizer, Zykadia (ceritinib) / Novartis, Alecensa (alectinib) / Roche
Review, Journal, IO biomarker: Role of STK11 in ALK-positive non-small cell lung cancer. (Pubmed Central) - May 10, 2022 Therefore, the main purpose of this review was to summarize the role of STK11 in ALK-positive NSCLC. The present review also summarizes the treatment and drug resistance studies in ALK-positive NSCLC and the current status of STK11 research in NSCLC.
- |||||||||| Zykadia (ceritinib) / Novartis, Mekinist (trametinib) / Novartis, BeiGene
Trial completion date, Trial termination, Trial primary completion date, Metastases: Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - May 10, 2022 P1/2, N=9, Terminated, The present review also summarizes the treatment and drug resistance studies in ALK-positive NSCLC and the current status of STK11 research in NSCLC. Trial completion date: Jan 2023 --> Apr 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2023 --> Apr 2022; Low Accrual
- |||||||||| Zykadia (ceritinib) / Novartis, Mekinist (trametinib) / Novartis, BeiGene
Enrollment closed, Trial completion date, Trial primary completion date: Study of Trametinib + Ceritinib in Patients With Unresectable Melanoma (clinicaltrials.gov) - May 9, 2022 P1, N=27, Active, not recruiting, Trial completion date: Jan 2023 --> Apr 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2023 --> Apr 2022; Low Accrual Recruiting --> Active, not recruiting | Trial completion date: Jun 2023 --> Dec 2023 | Trial primary completion date: Jun 2022 --> Dec 2022
- |||||||||| Zykadia (ceritinib) / Novartis, Mekinist (trametinib) / Novartis, BeiGene
Trial completion date, Trial primary completion date, Metastases: Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - May 3, 2022 P1/2, N=9, Active, not recruiting, Recruiting --> Active, not recruiting | Trial completion date: Jun 2023 --> Dec 2023 | Trial primary completion date: Jun 2022 --> Dec 2022 Trial completion date: Mar 2022 --> Jan 2023 | Trial primary completion date: Mar 2022 --> Jan 2023
- |||||||||| Ensacove (ensartinib) / Xcovery
Journal: Expert consensus on ensartinib in the treatment of anaplastic lymphoma kinase-positive non-small cell lung cancer (Pubmed Central) - Apr 29, 2022 In order to facilitate clinical application and provide patients with more treatment options, under the guidance of the Committee of Cancer Rehabilitation and Palliative Care of China Anti-Cancer Association, this article collects and summarizes the common adverse reactions of ensartinib. Based on the clinical practice, a clear adverse classification and specific treatment plan are formulated, in order to provide a corresponding reference for clinicians to make more comprehensive clinical decisions.
- |||||||||| Review, Journal: Targeting ALK Rearrangements in NSCLC: Current State of the Art. (Pubmed Central) - Apr 26, 2022
Recently, a potent, third-generation ALK inhibitor, lorlatinib, has been approved by the Food and Drug Administration (FDA) for the first-line treatment of ALK-positive (ALK+) NSCLC...Efforts have also been undertaken to develop further generations of ALK inhibitors. This review will summarize the current situation of targeting the ALK signaling pathway.
- |||||||||| Ibrance (palbociclib) / Pfizer, Zykadia (ceritinib) / Novartis, Farydak (panobinostat) / Secura Bio
UTILIZING TRANSCRIPTOME ANALYSIS TO IDENTIFY TARGETED THERAPY FOR EWING SARCOMA () - Apr 20, 2022 - Abstract #ASPHO2022ASPHO_480; HDAC, ALK, or CDK4 inhibition show a decrease in cell viability in ES cell line models as single agents and may potentiate the effects of chemotherapeutics currently used in patients with ES. Future studies of these agents in combination with chemotherapy will aim to determine efficacy in xenograft models.
- |||||||||| Lorbrena (lorlatinib) / Pfizer, Xalkori (crizotinib) / Pfizer, Zykadia (ceritinib) / Novartis
Journal: Targeting EML4-ALK gene fusion variant 3 in thyroid cancer. (Pubmed Central) - Apr 15, 2022 He received, after first-line lenvatinib, crizotinib (Drug Rediscovery Protocol (DRUP) trial), and lorlatinib (compassionate use)...To our best knowledge, this is the first reported case describing a patient-specific targeted treatment with lorlatinib based on an EML-ALK gene fusion v3 in a thyroid cancer patient, and own cancer cell line. Tumor-agnostic targeted therapy may provide valuable treatment options in personalized medicine.
- |||||||||| Zykadia (ceritinib) / Novartis
Clinical, Journal: Ceritinib in the treatment of an adult patient with advanced neuroblastoma positive to the somatic activating mutation of ALK F1174L. (Pubmed Central) - Apr 14, 2022 Neuroblastoma in adults (NB) is a rare tumor that can present somatic activating mutations in the ALK gene in 8-9% of patients (and up to 14% of high-risk NBs); these mutations occur in the tyrosine kinase domain in three key positions (F1174, F1245 and R1275), which account for approximately 85% of all ALK mutations in NB. In this article, we report the case of an adult patient with advanced mutation-positive NB treated with an ALK inhibitor ceritinib showing a therapeutic opportunity due to the molecular diagnostic techniques now available.
- |||||||||| Zykadia (ceritinib) / Novartis
Journal: EML4-ALK G1202R mutation induces EMT and confers resistance to ceritinib in NSCLC cells via activation of STAT3/Slug signaling. (Pubmed Central) - Apr 1, 2022 Furthermore, the combination of ALK and STAT3 inhibitors restored the sensitivity of EML4-ALK G1202R mutant cells to ceritinib. In conclusion, these data indicate that the EML4-ALK G1202R mutation mediates the EMT phenotype by activating the STAT3/Slug signaling pathway, resulting in resistance to ceritinib, and that the combination of STAT3 and ALK inhibitors may overcome ALK mutation-driven drug resistance in the clinic.
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