CLINICAL DEVELOPMENT IN ONCOLOGY
successful, it would be a major shift in the oncology sector,” said Jeff Hackman, CEO of the subcutaneous formulation technology company, Comera Life Sciences. Hackman adds that “Companies like Merck & Co developing the subcutaneous formulation for Keytruda sends a signal in the space that if you do not have a subcutaneous formulation of your therapy in your development plan, you could potentially be left behind.”
Reasons for the shift to subcutaneous therapies Apart from the obvious benefit of increased patient ease, subcutaneous or subQ formulations allow for lower costs, and a decreased time required for treatment. The cost savings come from not only time saved for both patients and staff, but also from reduced pharmacy costs since subcutaneous drugs have fixed doses, says Dr Andrew Wardley, the executive chair of the UK’s Association of Cancer Physicians. Intravenous infusions require pharmacy checks, notwithstanding different purchase costs, he says, adding that based on his research, subcutaneous preparations are clearly more cost-effective. As per Roche, Tecentriq SC can be administered in seven minutes compared to 30–60 minutes required for the intravenous formulation. Wardley states that the actual time saved could be more because administering multiple oncology drugs requires additional time to switch out drug bags and flush out the infusion line for any residual drugs. A subcutaneous injection can eliminate all of these factors that can increase the overall time of administering the therapy, says Wardley. One Spanish study, which compared the
cost of different versions of Biogen’s multiple sclerosis drug Tysabri (natalizumab), illustrates this point. The study found that using the subcutaneous version cost 62.3% less in the first year of use compared to the intravenous formulation. It also found that the reference hospital saved 116 hours of administrative and patient time and €3,682.42 ($3,978.4) in hospital costs, excluding the cost of the drug, per patient over a span of
“The major companies in the field [are] shifting their focus to developing subcutaneous formulations, [and] if successful, it would be a major shift in the oncology sector”
two years. Pharma companies are expecting clinicians
to prefer subcutaneous versions over intravenous ones. “We also hope [Tecentriq SC] will improve access for people with compromised veins, or in places with strained infusion centres, and help us to reach more patients,” says a Roche spokesperson. “Experience shows that [subcutaneous
versions] can cannibalize a significant share of their IV counterparts,” says Sakis Paliouras, PhD, associate director for Oncology, GlobalData. The Roche spokesperson adds: “In terms of adoption, the conversion rate we have seen with subcutaneous Phesgo (pertuzumab/trastuzumab/ hyaluronidase) in early launch countries, which has reached 35%, gives us confidence.” Phesgo was first approved as a subcutaneous therapy in the US as an adjuvant treatment for locally advanced or metastatic HER2-¬positive metastatic breast cancer in 2020. The drug generated $517m in sales in H1 2023, as per Roche’s H1 2023 report. Furthermore, there is a looming threat of
generics entering the immuno-oncology market space, as the Keytruda market exclusivity is set to expire in 2028. And if
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