Summarising the therapeutic and adverse effects of anticancer medicines according to race and sex: pooled analysis of clinical trials of contemporary treatments for solid tumours_Novartis_032022

Summarising the therapeutic and adverse effects of anticancer medicines according to race and sex: pooled analysis of clinical trials of contemporary treatments for solid tumours_Novartis_032022

Over the last decade there have been substantial advancements in the treatment of solid tumours, including the introduction of several new anticancer medicines such as immune checkpoint inhibitors, targeted therapies, and novel chemotherapies. However, response and toxicity to many of these new medicines remains highly unpredictable. Two factors urgently requiring investigation are potential differences in therapeutic and adverse effects of contemporary anticancer medicines according to race and sex [1, 2].Race differences are associated with a significant health disparity gap. For many common malignancies there are substantial differences in incidences according to race, while race is a phenotype (an observable trait) for differences in genetic and tumour biology factors. Further there are inequities in drug development processes (e.g., in reporting and representation) and it is unclear if this is resulting in systematic disparities in anticancer treatment therapeutic and adverse effects [1, 3-10]. Science is also becoming increasingly aware that sex is an important modifier of health, disease and medicine efficacy [11]; however, the availability of quality information to inform sex (or gender) differences in outcomes from anticancer medicines are currently limited [2, 12]. This project will bring together individual participant data from key clinical trials to summarise the therapeutic and adverse effects of contemporary anticancer medicines according to race and sex. Being able to appraise the expected response and adverse effect profile (benefit and risk profile) of anticancer treatments according to racial and sex differences will enable patients and clinicians to make better patient-centred decisions.

[{ "PostingID": 4120, "Title": "NOVARTIS-CLDK378X2101", "Description": "A Phase I, Multi-center, Open Label Dose Escalation Study of LDK378, Administered Orally in Adult Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase (ALK)" },{ "PostingID": 4122, "Title": "NOVARTIS-BRF113683", "Description": "A Phase III Randomized, Open-label Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma" },{ "PostingID": 4124, "Title": "NOVARTIS-BRF113929", "Description": "BRF113929: An Open-Label, Two-Cohort, Multicentre Study of GSK2118436 as a Single Agent in Treatment Naïve and Previously Treated Subjects With BRAF Mutation-Positive Metastatic Melanoma to the Brain" },{ "PostingID": 20573, "Title": "NOVARTIS-CDRB436B2301", "Description": "A Phase III, Randomized, Double-blinded Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to Dabrafenib and Placebo as First-line Therapy in Subjects With Unresectable (Stage IIIC) or Metastatic (Stage IV) BRAF V600E/K Mutation-positive Cutaneous Melanoma" },{ "PostingID": 20574, "Title": "NOVARTIS-CDRB436B2302", "Description": "A Phase III, Randomised, Open-label Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to the BRAF Inhibitor Vemurafenib in Subjects With Unresectable (Stage IIIc) or Metastatic (Stage IV) BRAF V600E/K Mutation Positive Cutaneous Melanoma" },{ "PostingID": 20819, "Title": "NOVARTIS-CDRB436B2204 (BRF117277", "Description": "BRF117277: A Phase II, Open-Label, Multicentre Study of Dabrafenib plus Trametinib in Subjects with BRAF Mutation-Positive Melanoma that has Metastasized to the Brain" },{ "PostingID": 20878, "Title": "NOVARTIS-CDRB436E2201", "Description": "A Phase II Study of the BRAF Inhibitor Dabrafenib as a Single Agent and in Combination With the MEK Inhibitor Trametinib in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer" },{ "PostingID": 20880, "Title": "NOVARTIS-CTMT212A2301 (GSK-114267)", "Description": "A Phase III Randomized, Open-label Study Comparing GSK1120212 to Chemotherapy in Subjects With Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma" }]