Oncology Trial Starts Soar in 2020, Despite Pandemic Disruptions
The number of oncology trial starts hit a record high in 2020, rising 60 percentage points above the 2015 total, according to a new IQVIA report on global oncology R&D trends. Oncology and rare diseases are the two largest areas of the clinical trials ecosystem, the report points out, and both were less disrupted by the pandemic than other areas of research.
Oncology and rare disease trials were the primary contributors to 2020’s high number of overall trial starts — nearly 3,500 new drugs — a 75-percentage point increase from 2015, IQVIA said. About 500 products targeting rare cancers were in late-stage development in 2020, a figure similar to the number of products in late-stage development for cancers with larger patient populations.
Half of the drugs in the late-phase oncology pipeline are for rare cancers and include a wide range of next-generation and targeted therapies. Similar numbers of products targeting rare cancers are in the early and late stages of development, signaling that the flow of such treatments in the pipeline will continue into the future.
Rare oncology trials had the highest success rate of all therapy areas, reaching 32.9 percent in 2020 — six times better than the success rate for larger population tumor trials, which was 5.5 percent. By comparison, the average success rate for all disease indications was 9.8 percent in 2020.
Trial complexity has been increasing in oncology trials overall since 2015 but has been declining in rare oncology trials because they are often able to enroll fewer patients. Oncology trials are longer than those targeting other diseases, but many trials have been able to skip phase 3 because regulators have either approved the candidate drug as a breakthrough therapy or given it some form of expedited review.
The report found that about 70 percent of ongoing oncology trials have molecular targets that would require pediatric trials under the Research to Accelerate Cures and Equity for Children Act, which was designed to improve and expand treatment options for pediatric cancer patients by requiring all new oncology drugs for adults also be tested in children when the molecular targets are relevant. The requirement took effect in August 2020.
A significant number of promising new approaches to precision oncology were in the early-stage oncology pipeline in 2020. According to IQVIA, the largest number of cancer researchers were focused on dozens of molecular targets for small-molecule therapies. Such therapies are getting approved and launched with increasing regularity and often can be administered orally — a benefit for cancer patients.
In the past decade, a resurgence in gene therapies — including gene-editing technologies, such as CRISPR and chimeric antigen receptor T (CAR-T) cell therapies — illustrate that the next generation of drugs in the early and late phases of the oncology pipeline will be focused on such innovations.
Read the IQVIA report here: https://bit.ly/3vP0GMq.