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Seeking to find their place in the extremely lucrative market for non-small cell lung cancer, some immuno-oncology companies have turned to the TMB research biomarker, or mutational burden of the tumor, in the hope of identifying patient populations for whom their treatments may be more effective. effective.
But the lung cancer giant Merck is throwing cold water on this idea. On Sunday, at the World Conference on Lung Cancer in Barcelona, the New Jersey drug manufacturer presented the results of two exploratory analyzes showing that there "does not seem to be any role" for TMB in the determining the patients most likely to benefit from its market treatment. Keytruda-chemo combo.
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The pharmaceutical giant has compiled TMB data from patients in its Phase 2 Keynote-021 study and in its Phase 3 Keynote-189 study, both examining the IO Keytruda star in tandem with chemotherapy in non-NSCLC patients. previously treated. In both trials, the combo showed consistent performance in patients with different levels of TMB, and Merck found no significant correlation between TMB and the combo's ability to induce patient response, delay progression of the disease or to prolong survival.
In short, "it turns out that the results are really unaffected by TMB's status," said Roy Baynes, M.D., Merck, senior vice president and director of global clinical development. Keynote-189, which cemented the Keytruda-chemo combo as a breakthrough treatment in first-line lung cancer, is "an important data set" and the new exploratory results "will help provide very good advice" to university doctors who are "obviously very intrigued by the TMB issue," he noted.
The results are good news for Merck because they "make it very clear that all patients who can tolerate chemotherapy" should receive the Keytruda couple on the front line, Baynes said.
But for companies that have sought to establish TMB as a means of segmenting the population, this is not a good sign. And unfortunately, these companies have not had many good signs to report in the past year.
RELATED: Skeptics were right: Bristol-Myers pulled an important Opdivo lung record while he waited for more data
In January, Bristol-Myers Squibb withdrew its application of Opdivo-Yervoy on the front-line lung, believing that it needed more data to show that the coupling was producing better results in TMB patients higher than the rest of the population. And in August, AstraZeneca announced that a combination of I-Imfini and tremelimumab candidate had been eliminated in patients with elevated TMB levels and presenting with stage 4 metastatic NSCLC when they were opposed to standard chemotherapy.
"The idea that you can better choose patients for alternative therapies or other TMB-based strategies – these data do not corroborate that," Baynes said of Merck's new findings.
This does not mean that the case is closed on the role of TMB in the selection of treatment. "We believe that TMB is an important area of study and we are studying it," Baynes said.
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