Two of the simplest ways to measure the success of companies that develop and commercialize drugs is to count their approvals and sales.
But a group of Harvard researchers has found another way to measure the impact individual drugmakers have had in bringing oncology treatments to the market—by assessing the clinical value of their new approvals.
Using a scoring system established a decade ago by the European Society of Medical Oncology (ESMO) to identify which approvals provide the highest clinical benefit, the researchers sorted the results by company. The scoring system is called the ESMO-Magnitude of Clinical Benefit Scale (MCBS).
Drugmakers at the top of the list were Astellas, AstraZeneca, Daiichi Sankyo, Gilead Sciences and Novartis. The five companies accounted for 71% of the high-benefit approvals over the past four years.
“I was surprised how concentrated it was. Five companies essentially counted for three-quarters of those high-benefit approvals and a lot of companies had no indications with high benefit,” Thomas Hwang, M.D., the founder of the Cancer Innovation and Regulation Initiative at the Dana-Farber Cancer Institute in Boston and a member of the ESMO-MCBS Extended Working Group, said in an interview.
Hwang recognizes the limitations of the analysis given its small sample size. For the purposes of the study, researchers tallied the high-benefit approvals gained by each company since 2020 from the European Medicines Agency (EMA). Additionally, since the ESMO scoring system applies only to solid tumor cancer approvals, there are many approved oncology treatments that are not included in the analysis.
To help round out the analysis, Hwang said the working group expects future research to include hematologic cancers and drugs approved by the FDA that are not yet endorsed in Europe.
Two major drugmakers at the bottom of the list—with no high-benefit solid tumor approvals over the span—were Roche and Eli Lilly. Also scoring poorly, with less than half of their approvals graded as high benefit, were Johnson & Johnson, Bristol Myers Squibb, Takeda and Amgen.
“These are companies that have large cancer R&D budgets.” Hwang said. “A lot of companies show up at ESMO with tons of presentations but some of those are for products that are pretty marginal at best.”
The results were presented Friday morning at the ESMO Congress in Barcelona.
Perhaps the most significant revelation in the analysis was that only one-third of the solid tumor cancer new drug approvals issued during the time frame cleared the high-benefit bar. For already approved drugs adding indications, 40% of the nods made the grade.
AstraZeneca and Novartis had a pair of drugs that made the grade. AZ's winners were Imjudo for liver and lung cancer and Truqap for breast cancer. Novartis captured nods for high-benefit therapies Piqray for breast cancer and Tabrecta for lung cancer. The Swiss company also partnered with BeiGene on another drug that scored high, Tevimbra for esophageal squamous cell carcinoma. Novartis relinquished its rights to the drug in September of last year.
Daiichi Sankyo had the best batting average as all four of its EMA approvals for powerhouse combination treatment Enhertu were categorized as high benefit.
Among other approvals tabbed as practice-changing were Astellas’ Padcev as the new standard of care for the first-line treatment of metastatic urothelial carcinoma. Another was Gilead’s Trodelvy as the top treatment option for unresectable or metastatic triple-negative HR+/HER2 breast cancer.
Other approvals that made the grade were GSK’s Jemperli (endometrial), Bayer’s Nubeqa (prostate). Seagen’s Tukysa (breast/colorectal) and Immunocore’s Kimmtrak (melanoma).
“Hopefully, this scoring system, which is public and reproducible, allows stakeholders to re-cast what we think of as beneficial and important to patients,” Hwang said. “Our analysis shows that a small number of pharmaceutical companies are responsible for most clinically valuable innovations in cancer in recent years. Better understanding and ultimately scaling the drivers for their success could transform the cancer R&D pipeline.”