Through the collaborative efforts of Bristol Myers Squibb and the partner data sources, I-O Optimise leverages secondary data (registry, electronic medical records, and cohort data) that were collected for research, claims, or audit purposes to explore a wide range of research questions. In contrast, a prospective registry study involves collection of primary data (ie, data that are specific to a predefined research protocol) which are used to answer a restricted set of research questions. Utilising existing secondary data may result in a more sustainable solution for data generation as it can economize stakeholders’ resources (both time and money) and allows for a flexible data-generation model.

Thoracic malignancies represent some of the leading causes of cancer-related mortality worldwide. The recent advent of immunotherapy has resulted in a paradigm shift in the treatment of these cancers, with an ever-increasing number of investigational and approved treatment options. As such, there is a need for a flexible approach that supports disease area research as treatment patterns in these thoracic malignancies advance and evolve. Real-world databases, if maintained and kept up to date, are a flexible and ready source of data that can be explored to provide rapid clinical insights that complement clinical trial data.

I-O Optimise has already generated numerous outputs looking at the pre-immunotherapy thoracic malignancies landscape, and research is continuing to gain more insights as immunotherapies become more widely used.

To date, data have been generated for patients with NSCLC, SCLC, and MPM in Europe and Canada. The team continue to look to work with suitable data sources in other countries and regions as part of the initiative.

At present, all generated data have come from electronic medical records, clinical data registries, or prospective cohort studies. Electronic medical records contain all captured information relating to a patient’s medical history and generally relate to patients from a single institution. A clinical data registry records information about the health status and healthcare of a predefined population (eg, by disease or treatment) and generally includes patients across a wide geography. A prospective cohort study is an analysis of specific predefined outcomes in a cohort of patients (eg, those with advanced NSCLC) over time. These studies can be conducted within a single institution or across multiple sites.

To date, focus has been on treatment patterns and clinical effectiveness, primarily through analysis of overall survival. As datasets mature, other efficacy outcomes, such as progression-free survival, will be explored, as well as additional domains such as safety/tolerability, healthcare resource utilisation, and health-related quality of life.

The data sources collaborating with the I-O Optimise initiative are updating their data at regular intervals, allowing for new patients and treatments to be assessed as the treatment landscape for thoracic malignancies evolves. Moreover, due to the fluid nature of this treatment landscape, the research objectives will also evolve, necessitating new data analyses and outputs.

Data are not currently being pooled for the core research program as the objectives are descriptive and do not require a specific sample size for testing hypotheses. Moreover, the pooling of data across independent data sources is often associated with methodological challenges. Pooling may be considered at a later date if these challenges can be overcome, and it is deemed necessary to answer specific research questions. Furthermore, as an alternative to data pooling, specific multi-database research initiatives are being explored.

Advice is provided by a multidisciplinary team of experts (clinicians, epidemiologists, health economists, and data source owners) who make up the independent ESC, which provides:

• Tactical/evaluative input – evaluate scientific protocols, analyses, and outputs
• Strategic guidance – advise on research prioritization and publication focus
• Advice on external engagement – support external communications (ie, publications, congress presentations, and other outreach activities)

In addition to the ESC, a larger group of consultants, including clinicians, epidemiologists, nurses, data source owners, and patient advocates, is convened regularly as part of the I-O Optimise Consortium program. The various Consortium workstreams are designed to (i) provide additional input on the program’s research objectives and related methodologies, (ii) foster collaboration between partner data sources and stakeholders, and (iii) raise the profile of I-O Optimise through advising on the optimal external dissemination of research outputs.

Since its inception, the I-O Optimise initiative has been based on the establishment of close working partnerships between Bristol Myers Squibb, researchers at the individual data sources, and IQVIA (an external partner who coordinate the data analyses). Within the context of these partnerships, Bristol Myers Squibb retains responsibility for the overall research priorities of the program, with all partner stakeholders contributing both to the development of specific research objectives and to the review and interpretation of the associated results. Bristol Myers Squibb is committed to publishing and sharing results from I-O Optimise with the wider scientific community.

The I-O Optimise initiative was first introduced to the public during a satellite symposium at the European Society for Medical Oncology (ESMO) Annual Congress in 2017. Since then, there have been more than 20 congress presentations and multiple manuscript publications. To view the latest I-O Optimise publications list, please visit www.io-optimise.com/publications.

As of Q2 2021, collaborations have been established with more than 10 sources from Canada, England, Portugal, Spain, Scandinavia, France, and Germany, with most having generated associated data.

To date, research from Denmark, Portugal, Sweden, and England have been presented/published, focusing on treatment patterns and clinical outcomes prior to the availability and widespread use of immunotherapies. To summarize, this research has shown that:

• Despite some recent improvements, most European patients with NSCLC, SCLC, and MPM are still diagnosed at an advanced stage
• In the pre-immunotherapy era, many patients with NSCLC or SCLC remained untreated and available treatments were generally suboptimal, particularly for advanced disease
• Certain thoracic cancer populations (eg, patients with advanced squamous cell NSCLC and patients with unresectable MPM) have particularly poor outcomes with traditional treatments and a high disease burden, highlighting a substantial unmet need for more effective therapies

Further information about I-O Optimise can be found on the I-O Optimise website (www.io-optimise.com) and through outreach activities. For specific questions, please email I-O_Optimise_Team@team-latitude.com.