ASCO 2024: Emphasising the art and science behind enhanced cancer care
The term “practice-changing” is often used when scientific advances promise to shift traditional treatment paradigms. Discussions coming out of the 60th American Society of Clinical Oncology (ASCO) annual meeting in June regarding practice-changing cancer therapies and care approaches were abundant. The meeting’s theme, “The Art and Science of Cancer Care: From Comfort to Cure,” best captured the importance of these advances: better ensuring all patients with cancer have access to high-quality care throughout their journey.
There is an art to cancer care that those in the oncology community aim to fine tune every chance we get to better address intricacies across varying patient populations and needs, cancer types, and therapies when used alone or in combination. This is especially true when gathered at ASCO, as there are many opportunities to connect with and learn from one another, take home fresh ideas and dive deeper into our individual efforts towards bettering cancer care, whether as a clinician, patient advocate, or drug developer.
Below are several noteworthy advances specific to oncology research and development shared during ASCO 2024 that can add to the art of cancer care and potentially transform treatment approaches for patients.
Navigating AI/ML to support faster and more accurate and quality care
There is no denying that artificial intelligence (AI) and machine learning (ML) and other technology-enabled solutions are truly revamping all aspects of oncology R&D.
For one, clinical trial sponsors are currently able to use millions of unique, de-identified patient records from claims data, medical records, and other real-world data sources to explore and understand patient journeys within specific types of cancer. By diving into nuances of treatment pathways and more with speed and accuracy, sponsors can make data-driven decisions about selecting their studies’ eligibility criteria and/or its endpoints. These insights can improve clinical trial design by ensuring they fit within current standards of care, which accelerate participant identification and engagement activities, one of the biggest challenges to trial completion.
AI-based solutions can also help drive identification, recruitment, and engagement efforts. For example, at ASCO, experts from the Montefiore Einstein Comprehensive Cancer Center in New York shared how an AI-based virtual patient navigator helped reach more patients from underserved communities of colour for an uptake on colorectal cancer screenings, with an overall patient volume increase of 36% from 2022 to 2023. The tool helped the “stretched workforce” with engagement activities, including calling patients to discuss screening scheduling and provide procedure prep reminders. It also helped assess barriers to screening uptake, colonoscopy completion rates, etc. There was, furthermore, discussion regarding AI technologies that use deep learning techniques to structure and summarise extensive oncology and haematology data, including biomarker data, to match patients to relevant trials quicker.
As 2023-2024 ASCO President Dr Lynn Schuchter noted in her keynote address, AI algorithms can help accelerate disease diagnoses with accuracy and even extract insights regarding a tumour’s genetic make-up. These technologies are also helping to reduce staff burnout by automating historically manual tasks within clinical trials. All of this means care teams can genuinely put focus back on the patients.
In improving the art of cancer care, the face time and active listening that patients need and deserve from clinicians to better understand their values, needs, and experiences can never be replaced by technology. Rather, technology is intended to support care teams in every aspect of compassionate cancer care. Data presented at ASCO regarding the benefits of early palliative care via telehealth for patients with advanced non-small cell lung cancer was a prime example of how the community can use technology to better consider patient quality of life needs in care approaches. Findings showed patients receiving early palliative care via telehealth demonstrated equivalent effects on quality of life compared to those receiving in-person visits, while reducing logistical burdens and more.
Building upon positive data findings for progression-free survival and more
From the numerous discussions happening at ASCO, one thing attendees may agree on is the sense of encouragement when we hear that pathways for innovative treatment plans that disrupt the status quo are expanding. Exploratory studies can provide a data-backed basis for potential uses of a specific treatment and reference points for future research. This is especially critical for patients living with cancers associated with lower survival rates, such as gastrointestinal and pancreatic cancers. Understanding how to get the dosage right or exploring novel targets and/or combinations of therapies can help prolong survival, while maintaining or improving quality of life. We discuss key takeaways from ASCO emphasising this below.
Difficult-to-treat solid tumours
Alligator Bioscience presented positive results from its OPTIMIZE-1 Phase II study, which examined its CD40 (cluster of differentiation 40) protein agonist immunotherapy mitazalimab in combination with the modified FOLFIRINOX chemotherapy as a first line therapy for metastatic pancreatic cancer. Also published in The Lancet Oncology during ASCO, data findings showed a 40% confirmed objective response rate, a 51% unconfirmed ORR, and a 79% disease control rate in 57 patients compared to a similar patient population treated with FOLFIRINOX alone, with a 31.6% ORR. The median duration of response was 12.5 months, which is longer than any other therapies, approved or investigational, to date. This is a notable achievement for patients with pancreatic cancer, as findings suggest adding mitazalimab to modified FOLFIRINOX may result in a meaningful extension of survival for the fatal disease. The company anticipates securing 18-month survival follow-up findings from the study in the coming weeks.
Additionally, the Shanghai-based biopharmaceutical company CARsgen reported final results from its Phase I study evaluating its autologous chimeric antigen receptor T-cell therapy satri-cel (satricabtagene autoleucel). The results showed promising efficacy and manageable safety profiles among patients with Claudin 18.2-positive advanced gastrointestinal cancers. Patients showed a clinical benefit rate of 42.1%, with median progression-free survival rate of 5.2 months and overall survival rate of 12.8 months after leukapheresis. The US Food and Drug Administration (FDA) granted satri-cel the Regenerative Medicine Advanced Therapy designation for this indication in 2022, emphasising its potential to address unmet medical needs and eligibility for accelerated approval as clinical evaluations continue.
Increasing insights on blood cancers via late-stage outcomes
This year at ASCO, there were several late-breaking and oral sessions dedicated to outcomes from multiple Phase III studies for various forms of blood cancers.
Attendees anticipated data readouts from multiple Phase III studies evaluating anti-CD38 monoclonal antibodies with combinations of standard of care treatments for multiple myeloma. The study findings noted below may signify increased care options for improved long-term outcomes regardless of whether patients are eligible for stem cell transplant:
- IMROZ, the first global Phase III study of an anti-CD38 monoclonal antibody, Sarclisa (isatuximab), in combination with the standard of care treatment regimen of bortezomib, lenalidomide and dexamethasone (VRd) for patients with newly diagnosed multiple myeloma and ineligible for transplant. Findings showed that Sarclisa in combination with the standard of care treatments “significantly reduced risk of progression or death by 40.4%,” with nearly 75% of patients treated with this regimen achieving complete response.
- PERSEUS, a Phase III study examining Johnson & Johnson’s anti-CD38 treatment, Darzalex Faspro (daratumumab and hyaluronidase-fihj), in combination with VRd followed by maintenance regimen of Darzalex Faspro with lenalidomide for patients with transplant-eligible newly diagnosed multiple myeloma. Findings showed a 33% reduction in the risk of death for patients treated with this combination compared to those treated by standard of care VRd.
Collectively, the impact of these findings and others for patients is that, with further examination of treatments in combination, they may help create a level playing field where transplant eligibility or ineligibility becomes irrelevant.
ASCO attendees also awaited Phase III results for GSK’s monoclonal antibody Blenrep (belantamab mafodotin), as previous monotherapy data indicated it was no more effective than currently available treatments for multiple myeloma. The DREAMM-8 study evaluated Blenrep in combination with pomalidomide plus dexamethasone versus a standard of care regimen for the second line and later treatment for relapsed or refractory multiple myeloma. Interim analysis outcomes showed that the regimen with Blenrep reduced the risk of progression or death by 48% compared to the standard of care regimen. This data supplements the DREAMM-7 Phase III study findings announced at the ASCO Plenary Series in February, where Blenrep combined with bortezomib plus dexamethasone showed a 59% reduction in risk of disease progression or death compared to Darzalex combined with bortezomib plus dexamethasone.
These outcomes help open doors for the potential for treatment paradigms going beyond chimeric antigen receptor T-cells or CAR-T therapies, which can have extensive manufacturing timelines and administration procedures. Another thought is to explore these therapies (e.g., antibody drug conjugates, CAR-Ts, etc.) in some combination or in sequence to determine how to optimise care paradigms.
In another blood cancer-specific study, oncology experts from Pfizer shared detailed data in a late-breaking session from its Phase III ECHELON-3 study that demonstrated how its antibody-drug conjugate ADCETRIS (brentuximab vedotin) in combination with immunomodulator lenalidomide and monoclonal antibody rituximab reduced risk of death by 37% for patients with relapsed/refractory diffuse large B-cell lymphoma compared to the backbone treatment. The ECHELON-3 study along with two other Phase III studies collectively demonstrate how ADCETRIS-based treatment plans may improve overall survival for patients with three different types of lymphoma, including stage IIb/III/IV Hodgkin’s lymphoma. Given DLBCL is the most common form of lymphoma and is aggressive, the improvement in survival rate is particularly important for patients whose disease has continued to advance after CAR-T or bispecific antibody treatments.
Additionally, new safety and efficacy data via the MANIFEST-2 Phase III trial evaluating the investigational BET (Bromodomain and Extra-Terminal motif) inhibitor pelabresib in combination with the JAK (janus kinase) inhibitor ruxolitinib in JAK inhibitor-naïve patients with myelofibrosis was announced. Findings showed that patients who were treated with the combination “significantly and durably reduced” the symptoms of enlarged spleen associated with the rare blood cancer and improved related anemia. As research continues to focus on myelofibrosis, it will be important to see how drug combinations can further improve patient responses and progression-free survival.
Broadening possibilities
Overall, the key advances from ASCO emphasise the sophistication and innovation within oncology R&D as the community continuously strives to elevate the art and science of cancer care for the many patients who need it. These examples of positive data outcomes give patients promise for tangible changes in treatment plans that can impact their survival and quality of life. They also provide a solid foundation for deeper exploration of the expanded use of novel and standard of care therapies, opening possibilities and access for more patient subpopulations.
As always in cancer care, there will be more progress to come, which is exciting to be a part of.
About the authors
Dr Sari Heitner Enschede is senior medical director and haematology-medical strategy lead of the Oncology Center of Excelllence at IQVIA. She has worked in the pharmaceutical industry for 18 years, with five years at IQVIA providing strategic guidance to customers for haematology studies and programmes and expert consultation and leveraging of professional networks for haematology-specific partnerships. Her previous experience at AbbVie/Abbott entailed leading global clinical trials in haematologic malignancies for Phases I-IV, with key roles in product safety, regulatory agency communications, and the launch of its BCL2 inhibitor Venetoclax. Prior to transitioning into the pharmaceutical industry, Enschede was an experienced haematologist who served as Assistant Professor in Medicine in the Department of Hematology-Oncology at Rush University in Chicago.
As VP of immuno-oncology & CAGT at IQVIA Biotech, Erin Finot, MS, MBA, is responsible for leading strategic direction to help sponsors meet their goals. As advancements in immuno-oncology and cell and gene therapies continue to transform patient care, Finot helps guide sponsors through a dynamic landscape with strong therapeutic expertise and more than two decades of experience in global clinical research and drug development processes.
Matt Simmons is senior director of oncology strategy at IQVIA Biotech, providing strategic guidance to the organisation’s oncology operational teams, as well as consultative oversight for biopharma and biotech sponsors developing therapeutics to treat cancer. He has more than 25 years of experience across all phases of drug development with large and small pharma, CROs, consulting, and software companies, as well as managing a leading oncology Phase I clinical research unit in London.
