Bristol-Myers Squibb's Immuno-Oncology Setback: Where Did BMS Go Wrong?
Recently, Bristol-Myers Squibb announced the failure of its immunotherapy trial, yet Big Pharma remains committed to new drug development and research. Meanwhile, BMS’s stock price plummeted. After all, failures in pharmaceutical trials are extremely rare.
In the wake of the shock, Opdivo andkeytrudaThe decisive battle will also unfold.OpdivoHas successively obtainedFDAApproved for the treatment of advanced melanoma, lung cancer, renal cell carcinoma, and classical Hodgkin lymphoma. Can be designated for any patient, includingKeytrudamarket share. According toFiercebiotechReport,BMSClaims,Opdivohas won over the United States and other major markets80%ofPD-1Expenditure Share. Undoubtedly, this is a contest between vastly unequal forces.
BMS is a research-based, global diversified enterprise engaged in pharmaceuticals, healthcare, and personal care products, with its core business spanning pharmaceuticals, consumer goods, nutritional supplements, and medical devices. It has been operating in the United States for100With a history spanning many years, it has now developed into a company with annual sales of200Hundreds of millions of dollars, worldwide120Multiple countries and regions, with54000a global enterprise with numerous employees. What are the reasons behindBMSEven an Old Horse Stumbles?
Timothy Byun, an oncologist at the Cancer Prevention and Treatment Center of St. Joseph Hospital in California, described Big Pharma’s research into cancer immunotherapy as a “gold rush.” He believes this research represents exciting news for both patients and physicians, yet he maintains that its greatest limitation lies in the uncertainty surrounding what constitutes a favorable response to immunotherapy. Take, for example, the biomarker assays used during the clinical trials of Merck’s Keytruda and Bristol Myers Squibb’s Opdivo. These assays were employed to select patients based on how their tumor cells expressed PD-L1.
“Currently, there are a total of3or4different types ofPD-L1Chemical Immunohistochemical Probes.MerckOne of them was used, andBMSThe two types used are withMerckDifferent probes,”Byun“It’s not an apples-to-apples comparison. You cannot determine whether the tumor cells identified using two different probes are correlated. In further studies, you would not know whether to test for cancer cells, immune cells, or both.”
Of course, some others attribute the failure to flaws in the BMS experimental design—this study was overly hasty in patient selection.
Currently, only about 20% of patients truly respond to immunotherapy. This means that greater effort must be devoted to the selection of samples for immunotherapy. However, determining which samples are suitable requires companies to invest more time and funding in predictive research on biological samples, as well as to conduct diagnostic testing.
Anssen Research & Development’s Vice President and Lead of Tumor Marker ResearchNicholas DracopoliAt the San Diego conference, it was stated that currently on the market159only a few anticancer drugs20Predictive studies and diagnostic testing of biological samples have been conducted in China.
Reviewing this limited dataset, Michael Kolodziej, an oncologist and former head of the oncology program, believes that there is a shortage of predictive biological specimens in pharmaceutical development. This failure is largely due toBig PharmaPharmaceutical companies are unwilling to invest time and money in determining which patients are suitable for immunotherapy drugs. He stated, “In my personal view, the identification of biomarkers is the most critical issue.”
At the Precision Pharmacy Summit held in Santiago, Panama on August 11, Kolodziej stated that currently, when it comes to novel immunotherapies, there appears to be no individual or organization proposing a standard for drug development strategies.
Kolodziej is now the National Medical Director,Flatiron HealthHealth Management Planning, via Google Ventures,RocheWith the company's support, an oncology software platform was developed.
What BMS is doing is truly inspiring. For a large proportion of cancer patients, this represents a novel therapeutic approach; however, only a small fraction ultimately benefit from it.
Kolodziej stated, “If you look at the development strategies of immuno-oncology pharmaceutical companies, they resemble those of the traditional chemotherapy industry. However, I am firmly convinced that we have the capacity to find solutions that can, to some extent, help us determine which patients are suitable for treatment.”
BMS SpokespersonPriyanka ShahIndicates "BMSThe unique mechanisms of action of tumor immunotherapy drugs were recognized early on, and their efficacy and side effects differ from those of traditional agents such as chemotherapy. To demonstrate the clinical value of tumor immunotherapy, we have adopted different approaches to develop these drugs, including how to evaluate their efficacy, design clinical trials, manage adverse reactions, and ultimately cure cancer patients.
“This is a historic period, with cancer patients awaiting new therapeutic drugs. We believe we have an unprecedented opportunity to transform cancer treatment, and we will continue to make significant strides forward to help more people overcome cancer.”
“We have initiated efforts to accelerate approval, breaking down all barriers that delay the market launch of drugs.”KolodziejsIndicates.
We believe that such an approach represents a win-win strategy, offering new hope to patients who have been disappointed by the lack of therapeutic efficacy, while also providing fresh insights for the field of pharmaceutical research.