Will Merck Win the Battle of First Immunotherapy Drug Approval?


Merck & Co. may win the race of having the approval of first immunotherapy drug for the treatment of non-small cell lung cancer. Rivals BMS and Roche are also trying hard with their candidates.

The first immunotherapy drug ‘Keytruda’ from Merck to treat the newly diagnosed non-small cell lung cancer (NSCLC) patients seems to win the race to have the approval of US Food and Drug administration (FDA) well before the rival.

keytruda merck pharma

The race isn’t over for rival Bristol-Myers Squibb (BMS) just yet; they are closing in fast to Merck. Another participant in the latest discovery of drug for immunotherapy patient is “Roche”. Roche is testing “Tecentriq” immunotherapy for lung cancer.

roche bms logo

Merck verbally accounted during the Clinical Trial named “KEYNOTE- 024”, Keytruda receiving patients showed better results than the chemotherapy patients (Standard treatment procedure for cancer patients) in the Progression Free Survival (PFS) as well as in the overall long run survival. The number to this claim was significantly missing which will be first reported in the medical meeting about the extent and longevity of Keytruda. Most probably this data presentation will be in the forthcoming October meeting of European Society for Medical Oncology.

Mode of Action & Target Patients/ to screen or not to screen

Both the drugs i.e. “Keytruda” and BMS “Opdivo” mode of action is to block the negative signal by stopping the interaction between programmed death ligand 1 (PD-L1) on tumor cells and PD-1 on T-Lymphocytes, that send negative signal to the immune system to not attack the tumor cells. Thus, both the drugs bind to the protein PD-1 and attack the tumor cells.

keytruda molecular mechanism

Figure 1.  How KEYTRUDA® works (photo credit: KEYTRUDA® MSD in New Zealand website).

Though both the drugs are made for later stage lung cancer, the only difference between Merck and BMS is in the target audience. While Merck screened the patients of PD-L1 thus only approving strong expressers of PD-L1, BMS skipped this step thus targeting larger group of patients. Similar trend was followed by Merck on its Clinical Trials of KEYNOTE-024, enrolling patients with high level of PD-L1 and tumor proportion of 50 percent or more. Even BMS will run a trial name Check Mate 026 to the newly detected cancer patient whose data will be submitted this year, but only in the condition if the “Opdivo trial” benefits patients.

Both this drugs are being tested as combinations with other drugs on patients. Such as, Keytruda is being tested with KEYNOTE-189 and KEYNOTE-407 on lung cancer patients in the clinical trial by Merck. BMS is testing Opdivo with chemotherapy.

Now, which drug attracts more patients or is more effective, will all depend on the clinical trials and the data followed by the clinical trials. This is a long fight with several more rounds to come. It is just one round of many but never the less Merck & Co., for now is definitely leading the race followed very close by BMS.

Featured image credit: ARCADIA CA – JAN 23. © wingbeats551 (Stock Photo ID: 7045270)

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