Lung cancer may have just met a new standard of care. On top of that, it would be considered a new standard as a first line of care in lung cancer and longer overall survival rates. Shares of Merck & Co. Inc. (NYSE: MRK) saw an increase in value while shares rival drug maker Bristol-Myers Squibb Co. (NYSE: BMY) traded lower after lung cancer study results were presented at the American Association for Cancer Research annual meeting.
The long and short of the matter is that Keytruda is now the first immunotherapy to significantly extend survival of patients with nonsquamous non-small-cell lung carcinoma (NSCLC) in combination with chemotherapy as a first-line treatment. Keytruda had previously met its dual primary endpoints of overall survival and progression-free survival when combined with chemotherapies. It is now on track to become the new standard in first-line lung cancer treatment. That could translate to billions of dollars in additional annual sales.
While the Merck results will set a high bar for rivals, analysts at Credit Suisse and Sanford Bernstein both are calling Merck’s study superior. Credit Suisse said the results were better than expected on all patient subgroups. Bernstein’s notes indicate that Merck is now expected to remain in the driver’s seat as a first line of defense in lung cancer.
Bristol-Myers Squibb has Opdivo and Yervoy immunotherapies already on the market in the United States. To show how much more this may mean for Merck with its 2% gain: Bristol-Myers Squibb shares were lower by almost 8% after the results were compared.
Some of the good news around Keytruda had been seen already, but the level of the success was the driving point. Merck’s study findings showed that the Keytruda-pemetrexed-platinum chemotherapy combination significantly improved overall survival by reducing the risk of death by half compared with chemotherapy alone. The anti-PD-1 therapy works by increasing the body’s immune system to help detect and fight tumor cells.
Merck’s press release included an outside comment from Dr. Leena Gandhi, director of thoracic medical oncology at NYU Langone’s Perlmutter Cancer Center and lead author of the New England Journal of Medicine paper. Gandhi said:
In this trial, KEYTRUDA in combination with pemetrexed and platinum chemotherapy, compared with chemotherapy alone, prolonged overall survival and progression-free survival in patients with advanced nonsquamous non-small cell lung cancer regardless of PD-L1 expression. There is good scientific rationale for combining KEYTRUDA with pemetrexed and platinum chemotherapy, and these clinical data now suggest this combination as a new standard of care for the first-line treatment of these nonsquamous non-small cell lung cancer patients.
And the impact was also out there on biotech outfits with immunotherapies in studies. Nektar Therapeutics (NASDAQ: NKTR) was down 10% at $90.30, and that is a loss of about $1.5 billion in market capitalization, down to $14.5 billion.
Mirati Therapeutics Inc. (NASDAQ: MRTX) was last seen down 2.7% at $30.35, with an $880 million market value. Another biotech catching negative fallout was Syndax Pharmaceuticals Inc. (NASDAQ: SNDX), after its drop of over 4% to $10.95 gave it a market value of $270 million.
The safety profile of Keytruda in this combination was consistent with that previously observed. Keytruda is Merck’s bread and butter cancer drug, with multiple indications reaching across many different cancers, including melanoma, head and neck cancer, classical Hodgkin lymphoma, urothelial carcinoma, microsatellite instability-high cancer and gastric cancer. All in all, Merck has some 700 different studies tied to Keytruda.
Merck’s total sales in 2017 were $40.1 billion, up from $39.8 billion in 2016. Keytruda sales were $3.81 billion in 2017, up 172% from the $1.4 billion mark a year earlier. When Merck issued its preliminary 2018 full-year worldwide sales target of $41.2 billion to $42.7 billion, these latest results had not been shown in as much detail as this much more superior.
With lung cancer, non-small cell and small cell are the two main types. NSCLC is the most common type of lung cancer, with a tally of about 85% of the cases. The five-year U.S. survival rate for patients diagnosed with any stage of lung cancer is estimated to be only 18%.
Dr. Roger M. Perlmutter, president of Merck Research Laboratories, said:
Our goal is to extend the lives of patients with lung cancer, and the unambiguous survival findings from KEYNOTE-189 showing the risk of death was reduced by half in the KEYTRUDA arm are important not only for patients but also for the medical community. The results of this trial have the potential to change the treatment paradigm for patients with nonsquamous non-small cell lung cancer in the first-line setting, including patients whose tumors are either PD-L1 negative or are untested.
Shares of Merck were last seen up about 2.6% at $58.65, with a consensus analyst price target of $66.50 and a 52-week range of $53.12 to $66.41.