Attending the American Society of Clinical Oncology (ASCO) annual meeting this year, we had the chance to meet up with others in research and development (R&D), service partners and clinicians to participate in discussions about notable advancements in global cancer care over the last year. Participating in or attending key oral sessions, clinical science symposiums, poster presentations or simply having coffee break chats with colleagues across regions and disciplines, it’s obvious we all shared a passion to elevate innovation in cancer care.
From a R&D perspective, we are excited to leave ASCO with useful learnings, best practices and opportunities to continue collaborative conversations with stakeholders to further accelerate the innovative oncology breakthroughs, ensuring they are reaching patients faster to make a genuine difference in their lives and health. From global oncology R&D trends to the role of real world evidence in trials to patient-centered approaches, the industry has put a great amount of investment in cancer care and drug development, which was emphasized at ASCO. With so many advancements, it’s hard to select a few, but below are some of the interesting topics and trends highlighted at this year’s meeting.
Caring for all with cancer
For decades, the industry has worked to expand trial access and participation to engage diverse and underserved patient populations affected by cancer, but it has been a complex and multi-pronged challenge. With COVID-19 highlighting gaps in diversity and inclusion in clinical trials, the oncology community is more committed than ever to leverage our collective expertise and innovative solutions and technologies to create the change we want to see.
As the key theme of ASCO ‘22, there were many opportunities to share ways to enhance equitable cancer care with fellow stakeholders. Firstly, it’s important the industry as a whole starts changing our mind set around how we address lack of diversity in oncology trials. For one, there needs to be an intentional focus on diversity during the early planning stages of trial design. By understanding and working to address participation barriers and individualized patient and caregiver burdens early in the process, sponsors and study teams can integrate the appropriate expertise and solutions to help reach target patient populations without trial delays. Leveraging experiences from COVID-19 vaccine trials outreach, sponsors and CRO partners are utilizing non-traditional strategies to reach the right patients for the right oncology trials by collaboration with social media companies, tech solutions companies and more. And, as possible, some are working with sponsors to better engage diverse investigators to help build trust among patient populations and reach patients where they live.
Checkpoint inhibitor influx
Transforming the oncology landscape, checkpoint inhibitors have been the catalyst for the overall development of immuno-oncology therapies in recent years. This has also led to a crowded marketplace in R&D—emphasizing a need for trial sponsors and clinical research organizations (CROs) to address challenges in recruiting treatment naïve patient populations. For example, currently there are nearly 4,900 clinical trials examining anti-PD1/PDL1 monoclonal antibodies for various forms of cancer, which represents a 267 percent increase in total number of these trials since five years ago in 2017. But, how does the industry respond to this level of growth?
Some sponsors are focusing their patient recruitment efforts for anti-PD1/PDL1 trials, whether in monotherapy or combination settings, in Asia-Pacific (APAC) countries with China leading the way. At IQVIA, we are seeing that local interest in participation is helpful in accelerating recruitment, especially as China offers a large patient population who may meet eligibility criteria and are treatment-naïve. And, with the lower operational costs to conduct trials in China compared to the U.S. and Europe along with its comprehensive trial infrastructure, it is attractive for sponsors.
Additionally, in aiming to improve PD1/PDL1 therapies, elevated collaboration between sponsors of approved inhibitors and those developing novel agents would help ensure the therapies under investigation are not offering nominal improvements to what is currently available to patients. The U.S. Food and Drug Administration and other regulatory agencies have expressed interest in more sponsor collaboration to help demonstrate differentiation as well.
Leading therapeutic innovation
As the oncology community aims to enhance patient outcomes by increasing trial awareness, access and participation, it is encouraging to see that in terms of clinical trial activity, the size of therapy pipelines in development, R&D spend and more, oncology is the therapeutic space leading innovation. A record 30 oncology novel active substances were launched globally in 2021. Though not all are available in every country, some of the immuno-oncology treatments and use of precision biomarkers are becoming the standard of care in many types of tumors.
According to the IQVIA Institute’s 2022 Global Oncology Trends report released weeks before ASCO, the average number of patients worldwide who have received cancer treatment has increased by four percent over the past five years. However, with such tremendous oncology R&D progress, it’s important to shed light on the need for better treatment access in lower income countries as well as determining if adoption of decentralized trial elements and more can help make sure patients who lack resources or are too far from treatment sites have access to potentially life-saving treatments.
Other notable discussions
In addition to the topics noted above, there were several discussions that kept coming up at ASCO:
· Liquid biopsies: Whether it was the detection of minimal residual disease, cancer screening and early detection, disease treatment monitoring, identification of therapeutic targets or understanding metastasis, the detection of cancer cells or DNA from tumor cells in blood samples is a powerful technology that will be a critical part of oncology trials and oncology care moving forward.
· Dosing finding with targeted therapies: Companies are rethinking the way they design early phase trials, shifting from the idea of maximal tolerated dose to the concept of dose optimization.
· Destiny-4 Breast Cancer trial in patients with Her-2 low metastatic breast cancer: The results unveiled at ASCO will almost certainly change the standard of care in this population.
The level of innovation coming out of the oncology community is truly remarkable to see. However, all the advancements and breakthroughs we are making must be purposeful, with the intention of impacting the day-to-day lives of patients around the world. Though the development landscape is increasingly complex, seeing how we are collectively pushing innovation boundaries is extremely motivating as we wrap up ASCO.
From a R&D perspective, we are excited to leave ASCO with useful learnings, best practices and opportunities to continue collaborative conversations with stakeholders to further accelerate the innovative oncology breakthroughs, ensuring they are reaching patients faster to make a genuine difference in their lives and health. From global oncology R&D trends to the role of real world evidence in trials to patient-centered approaches, the industry has put a great amount of investment in cancer care and drug development, which was emphasized at ASCO. With so many advancements, it’s hard to select a few, but below are some of the interesting topics and trends highlighted at this year’s meeting.
Caring for all with cancer
For decades, the industry has worked to expand trial access and participation to engage diverse and underserved patient populations affected by cancer, but it has been a complex and multi-pronged challenge. With COVID-19 highlighting gaps in diversity and inclusion in clinical trials, the oncology community is more committed than ever to leverage our collective expertise and innovative solutions and technologies to create the change we want to see.
As the key theme of ASCO ‘22, there were many opportunities to share ways to enhance equitable cancer care with fellow stakeholders. Firstly, it’s important the industry as a whole starts changing our mind set around how we address lack of diversity in oncology trials. For one, there needs to be an intentional focus on diversity during the early planning stages of trial design. By understanding and working to address participation barriers and individualized patient and caregiver burdens early in the process, sponsors and study teams can integrate the appropriate expertise and solutions to help reach target patient populations without trial delays. Leveraging experiences from COVID-19 vaccine trials outreach, sponsors and CRO partners are utilizing non-traditional strategies to reach the right patients for the right oncology trials by collaboration with social media companies, tech solutions companies and more. And, as possible, some are working with sponsors to better engage diverse investigators to help build trust among patient populations and reach patients where they live.
Checkpoint inhibitor influx
Transforming the oncology landscape, checkpoint inhibitors have been the catalyst for the overall development of immuno-oncology therapies in recent years. This has also led to a crowded marketplace in R&D—emphasizing a need for trial sponsors and clinical research organizations (CROs) to address challenges in recruiting treatment naïve patient populations. For example, currently there are nearly 4,900 clinical trials examining anti-PD1/PDL1 monoclonal antibodies for various forms of cancer, which represents a 267 percent increase in total number of these trials since five years ago in 2017. But, how does the industry respond to this level of growth?
Some sponsors are focusing their patient recruitment efforts for anti-PD1/PDL1 trials, whether in monotherapy or combination settings, in Asia-Pacific (APAC) countries with China leading the way. At IQVIA, we are seeing that local interest in participation is helpful in accelerating recruitment, especially as China offers a large patient population who may meet eligibility criteria and are treatment-naïve. And, with the lower operational costs to conduct trials in China compared to the U.S. and Europe along with its comprehensive trial infrastructure, it is attractive for sponsors.
Additionally, in aiming to improve PD1/PDL1 therapies, elevated collaboration between sponsors of approved inhibitors and those developing novel agents would help ensure the therapies under investigation are not offering nominal improvements to what is currently available to patients. The U.S. Food and Drug Administration and other regulatory agencies have expressed interest in more sponsor collaboration to help demonstrate differentiation as well.
Leading therapeutic innovation
As the oncology community aims to enhance patient outcomes by increasing trial awareness, access and participation, it is encouraging to see that in terms of clinical trial activity, the size of therapy pipelines in development, R&D spend and more, oncology is the therapeutic space leading innovation. A record 30 oncology novel active substances were launched globally in 2021. Though not all are available in every country, some of the immuno-oncology treatments and use of precision biomarkers are becoming the standard of care in many types of tumors.
According to the IQVIA Institute’s 2022 Global Oncology Trends report released weeks before ASCO, the average number of patients worldwide who have received cancer treatment has increased by four percent over the past five years. However, with such tremendous oncology R&D progress, it’s important to shed light on the need for better treatment access in lower income countries as well as determining if adoption of decentralized trial elements and more can help make sure patients who lack resources or are too far from treatment sites have access to potentially life-saving treatments.
Other notable discussions
In addition to the topics noted above, there were several discussions that kept coming up at ASCO:
· Liquid biopsies: Whether it was the detection of minimal residual disease, cancer screening and early detection, disease treatment monitoring, identification of therapeutic targets or understanding metastasis, the detection of cancer cells or DNA from tumor cells in blood samples is a powerful technology that will be a critical part of oncology trials and oncology care moving forward.
· Dosing finding with targeted therapies: Companies are rethinking the way they design early phase trials, shifting from the idea of maximal tolerated dose to the concept of dose optimization.
· Destiny-4 Breast Cancer trial in patients with Her-2 low metastatic breast cancer: The results unveiled at ASCO will almost certainly change the standard of care in this population.
The level of innovation coming out of the oncology community is truly remarkable to see. However, all the advancements and breakthroughs we are making must be purposeful, with the intention of impacting the day-to-day lives of patients around the world. Though the development landscape is increasingly complex, seeing how we are collectively pushing innovation boundaries is extremely motivating as we wrap up ASCO.
Head of the Hematology/Oncology Center of Excellence at IQVIA, Dr. Jeffrey Keefer is a board-certified pediatric hematologist and oncologist with 12 years of academic faculty experience in the Johns Hopkins University School of Medicine’s Division of Pediatric Hematology. Prior to his current role, he led the Pediatric and Rare Diseases Center of Excellence at IQVIA.