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Rates of clinical trial initiation, novel drug development, and collaborative research and development deals were oncology.
Rates of clinical trial initiation, novel drug development, and collaborative research and development deals were oncology, according to data from the global trends in research and development report issued by IQVIA.
In regard to clinical trial initiation, in particular those with a focus on rare cancers, launch rates reached historically high levels in 2020. Specifically, clinical trials in oncology were up 60% from 2015 with 63% of all oncology trials focusing on advancing care for patients with rare malignancies.1 Further, IQVIA reported that oncology drugdevelopment accounts for 40% share of the early-stage pipeline and 30% of the late-stage pipeline.
The report comprised an analysis of initiated trials that included a focus on the effect of the COVID-19 pandemic and COVID-19–specific research. Overall, the report noted that across specialties there was an 8% increase in clinical trial initiation in 2020. Disruption in trial enrollment and launch because of restriction on in-person activity by the COVID-19 pandemic reflected an increase in trials that were remote, virtual, or decentralized.
“The life sciences innovation system–including hundreds of companies, governments, researchers, doctors, and nurses–adapted to the COVID-19 pandemic in ways large and small,” wrote the authors of the report.
IQVIA noted that approvals in 2020 in oncology, neurology and infectious diseases including COVID-19 vaccines launched under Emergency Use Authorization comprised 73% of total novel drug launches in 2020.1 In hematology/oncology specifically, 21 novel agents were approved, including 3 diagnostic imaging agents for the treatment of patients with breast cancer, prostate cancer, and neuroendocrine tumors, respectively.2 According to IQVIA data, novel oncology drugs account for 27% of the 5-year launch total for novel agents.1
In terms of new activity, emerging biopharma companies originated and launched 40% of all new drugs in 2020, reflecting greater independence in development activities. Emerging biopharma companies were defined by IQVIA as those with less than $500 million in sales and less than $200 million in research and development spend each year. For example, the approval of ripretinib (Qinlock) marked a win for the commercial-stage biopharmaceutical company Deciphera Pharmaceuticals, LLC. Ripretinib was approved on May 15, 2020, for the treatment of adult patients with advanced gastrointestinal stromal tumor who have received prior treatment with 3 or more kinase inhibitors, including imatinib.2
The report also highlighted several agents with unique pathways to launch and/or initial filing for review with the FDA. These events include changes in ownership either between collaborations among emerging biopharma or large pharma acquisitions. For example, the report featured the approval pathway of tazemetostat (Tazverik) which was granted accelerated approval on June 18, 2020.2
The EZH2 inhibitor was initially developed by Epizyme Inc and the development of it began as a collaboration between small biopharma and emerging biopharma between Eisai Co, Ltd and Epizyme Inc for the development and commercialization of the product. In 2015, an amendment agreement relegated Eisai the sole responsibility of development and commercialization in Japan, paying royalties to Epizyme. In 2019, the agent entered a new phase of ownership with Eisai transferring its rights to receive royalties on sales of tazemetostat outside of Japan to Royalty Pharma.4
During this pathway to launch, the agent moved from phase 1 to phase 3 trials, received orphan drug and fast track designations prior to the June 2020 accelerated approval.
Oncology remained a focal point for research and development deals, accounting for 16% of the total deals made in 2020. This is down from 19% in 2019. The report cited the $21 billion acquisition of Immunomedics by Gilead Sciences which included sacituzumab govitecan (Trodelvy), as well as the $4.9 billion acquisition of Forty Seven which included magrolimab.1
Sacituzumab govitecan received regular approval on April 7 for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received 2 or more prior systemic therapies, at least one of them for metastatic disease.4 Magrolimab was granted breakthrough therapy designation to magrolimab for the treatment of newly diagnosed myelodysplastic syndrome in September 2020 and is under investigation for patients with acute myeloid leukemia, diffuse large B-cell lymphoma, and follicular lymphoma.5