As for some of the most significant changes to the clinical trial landscape over the last year, Michael Kleinrock, research director at the Iqvia Institute, noted setbacks in some promising mechanisms. Among these includes 1D01 failures in melanoma, as well as some challenges for immune-oncology (I/O) drugs in lung cancer.
“For the most part there were a large number of trials, drugs in development, and an increasing number of emerging companies launching their own assets,” Kleinrock told us.
Driving these changes is decades of investment in oncology “coming to fruition,” Kleinrock said, “yet the overall oncology pipeline is the largest in pharma and even more is expected in the future.”
According to the report, of the top 33 big pharma companies, 28 are developing anti-cancer molecules, among the more than 700 companies working in this space. This includes 626 emerging biopharma companies, of which, almost 500 are focused exclusively on oncology.
For outsourcing companies, Kleinrock said the entrance of smaller firms has created promising opportunities for partnerships.
“Some emerging companies are building out their in-house capabilities but doing so in an efficient and experienced and savvy way is complicated,” he explained.
“There are some important investments in technology, AI and machine learning and other tools that larger companies or outsourcing firms can do but a startup with an executive team (and little else) would be hard pressed to do.”
Many of these technology investments aim to speed the drug development timeline, which for new oncology drugs launched in 2018 was 10.5 years from the time of first patent filing to regulatory approval and launch – four years faster than 2017.
Last year, for an oncology therapy with breakthrough status, the average interval from first patent filing to launch was 10.1 years, per the report. This, compared to an average of 18 years for all other therapy areas.
However, the availability of pre-screened patient pools and biomarker tests could improve productivity by as much as 104% and 71%, respectively, by 2023, according to Iqvia.
“There are some critical success factors for companies, particularly emerging companies, some of which rely upon awareness of the evolutions in the market, and some will require specific investment and organizational choices depending on their products or assets,” Kleinrock added.
“The most telling of these factors could be the ability to negotiate with a potential large pharma purchaser by knowing what things cost,” he said.
Currently, there are nearly 450 immunotherapies in the clinical pipeline, which are identified with more than 60 different mechanisms of action (MOA), according to the report. There also are more than 100 next-generation biotherapeutics in clinical trials focusing on 18 different MOAs.
Kleinrock added, “By working with outsourcing partners, an emerging company might have a clear view of what it would take for them to go to market alone. That potential independence may allow them to negotiate more effectively, or to defer or decline a deal that unfairly undervalues their assets.”
2018 saw a record 15 new active substance (NAS) oncology treatments with 17 indications, including one tissue-agnostic therapy, launched in the US, according to the report.
These launches covered 89 approved indications for 23 different tumor types, bringing the total number of new oncology therapeutics launched since 2013 to 57.
As Kleinrock explained, working with an outsourcer can help a company grow organically, and prepare an asset for a potential sale. This is all “part of the journey for emerging companies,” he said, “and serving that journey is the role many outsourcing companies play, whether it be in research outsourcing, process or commercial outsourcing, and salesforce.”