- |||||||||| Zykadia (ceritinib) / Novartis
Journal, IO biomarker: Protein kinase inhibitor ceritinib blocks ectonucleotidase CD39 - a promising target for cancer immunotherapy. (Pubmed Central) - Aug 28, 2022 Ceritinib is a novel CD39 inhibitor with high metabolic stability and optimized physicochemical properties; according to our knowledge, it is the first brain-permeant CD39 inhibitor. Our discovery will provide the basis (i) to develop more potent and balanced dual CD39/ALK inhibitors, and (ii) to optimize the ceritinib scaffold towards interaction with CD39 to obtain potent and selective drug-like CD39 inhibitors for future in vivo studies.
- |||||||||| Xalkori (crizotinib) / Pfizer, Zykadia (ceritinib) / Novartis, Alecensa (alectinib) / Roche
Review, Journal: Anaplastic lymphoma kinase inhibitors and their effect on the kidney. (Pubmed Central) - Jul 29, 2022 According to the package insert and published literature, treatment with several ALK-1 inhibitors appears to be associated with the development of peripheral edema and rare electrolyte disorders, kidney failure, proteinuria and an increased risk for the development and progression of renal cysts. This review introduces the different types of ALK inhibitors, focusing on their detailed kidney-related side effects in clinical practice.
- |||||||||| Xalkori (crizotinib) / Pfizer, Zykadia (ceritinib) / Novartis, Gilotrif (afatinib) / Boehringer Ingelheim
New trial: Antineoplastic Drugs in Elderly Patients (clinicaltrials.gov) - Jul 20, 2022 P=N/A, N=500, Recruiting,
- |||||||||| Lorbrena (lorlatinib) / Pfizer, Lynparza (olaparib) / Merck (MSD), AstraZeneca
Journal, BRCA Biomarker, PARP Biomarker: Rapid and durable response to fifth-line lorlatinib plus olaparib in an ALK-rearranged, BRCA2-mutated metastatic lung adenocarcinoma patient with critical tracheal stenosis: a case report. (Pubmed Central) - Jul 17, 2022 She was treated with alectinib and acquired ALK p.I1171N and p.V1180L mutations...After sequential lines of ceritinib and chemotherapy, lorlatinib was chosen as the fourth-line therapy and maintained control for 6 months...To the best of our knowledge, this case is the first to provide clinical evidence of antitumor activity of olaparib plus ALK TKI in ALK-positive, gBRCA-mutated metastatic NSCLC. Together with previous reports in EGFR-positive or driver-negative patients, our finding warrants further studies on PARP inhibition in BRCA1/2-mutated NSCLC.
- |||||||||| Zykadia (ceritinib) / Novartis, alvocidib (DSP-2033) / Sumitomo Dainippon, dinaciclib (MK-7965) / Ligand, Merck (MSD)
IDENTIFICATION OF NOVEL THERAPEUTICS FOR HEPATOBLASTOMA USING A PATIENT-DERIVED XENOGRAFT IN VITRO DRUG TESTING PLATFORM (Hall 7) - Jul 16, 2022 - Abstract #SIOP2022SIOP_480; Most importantly, these drugs significantly reduced growth of a patient-derived xenograft model when transplanted into nude mice.ConclusionsWe were able to establish a platform for rapid, reproducible and reliable validation of potential drug candidates. Our results strongly suggest that ceritinib, dinaciclib, alvocidib, and mebendazole can be applied as an alternative therapeutic approach for hepatoblastoma.
- |||||||||| 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
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