MSD’s Keytruda becomes the 'symbol' of cancer immunotherapy

Blockbuster Anticancer Drugs | Episode 1: Keytruda

Keytruda secures 18 indications in 14 cancer types... 120 studies are being conducted that involves Korea

Rises as the No.1 global anticancer drug…whether its reimbursement will be extended to the indications remain an issue

Pic.

 

of Keytruda

“Reinforcing the body’s immunity to attack cancer cells” By some, the idea was regarded improbable.

 

Not many were convinced that immunotherapy would rise to the position it is in now.

 

Even without reference to the famous story of how the former US president Jimmy Carter cured melanoma with immunotherapy, cancer immunotherapy has become an important pillar in the management of cancer disease nowadays.

 

Among the many drugs introduced, MSD’s (Merck in the US) ‘Keytruda (pembrolizumab)’ has risen to become the symbol of ‘cancer immunotherapy.’ The drug, which was first approved in March 2015 as a treatment for melanoma, is currently approved for 18 indications in 14 cancer types in Korea.

 

One thing to note is that Keytruda is yet far from reaching its turning point.

 

◆A neglected substance becomes an all-around anticancer drug Keytruda’s history goes all the way back to 2003.

 

Keytruda was developed as a humanized antibody by Organon, a Dutch pharmaceutical Company.

 

In 2007, Organon was acquired by Schering Plough, and the substance was approved for clinical trials by the FDA in December 2012.

 

In 2014, only 3 years after trial approval, the company submitted a New Drug Application to the FDA and received approval as a treatment for melanoma in September of the same year.

 

This was how Keytruda’s journey began.

 

One interesting aspect to note is that MSD was not a prominent player in the field of oncology.

 

The company, whose key areas focused on chronic disease, women’s disease, and vaccines, realized the potential of Keytruda and established a business division for the single drug.

 

MSD’s insight and drive in making the decision to invest in a substance that was neglected by the initial developer is also one key strength of the company to note.

 

After the initial melanoma indication, Keytruda was approved as a second-line treatment for non-small cell lung cancer in 2016, an area in fierce competition.

 

Then, the drug became the first among cancer immunotherapies to receive approval as a first-line treatment for Stage 4 metastatic NSCLC.

 

Afterward, by adding the combination therapy option to its treatment regiment, the drug’s indication was expanded from patients with high PD-L1 expression to all patients to position itself as the standard treatment option for all patients with metastatic NSCLC.

 

Also, Keytruda transformed the concept of cancer treatment by becoming the first to be approved for ‘tumor agnostic' use in all cancer types based on specific genetic features regardless of the initial cancer site.

 

In Korea, the drug was approved as a second-line treatment for 7 types of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, and more recently, as a first-line treatment for metastatic MSI-H/dMMR colorectal cancer.

 

Keytruda

◆MSD Reaps rewards for its foresight… No.1 in sales in both Korea and the global market The company reaped rewards from its aggressive investment.

 

Keytruda recorded No.1 in global sales in 2020, earning $14.38 billion (₩16.8 trillion as of August 18th, 2021).

 

The same went for Korea as well.

 

According to IQVIA, Keytruda recorded ₩155.7 billion in the domestic pharmaceutical market in 2020 to rank first among all pharmaceuticals in sales and has maintained the lead in the first half of this year.

 

In the early years of its release, in 2016 and 2017, Keytruda sold around ₩10 billion’s worth; however, its sales hit ₩70 billion in 2018.

 

The upsurge was driven by its reimbursement approval as second-line treatment for NSCLC in August 2017.

 

As previously mentioned, much potential remains for Keytruda.

 

MSD is conducting more than 1,400 global clinical trials focusing on Keytruda.

 

Korea’s contribution is also quite significant in the area.

 

Around 120 of the global anticancer therapy trials being led by MSD are being conducted in Korea and consist of around 88% of all trials conducted by MSD Korea.

 

Based on the number of participating patients, Korea has ranked 1st among Asia-Pacific countries and 4th in global.

 

◆The remaining challenge...a rough ride to reimbursement extension However, obstacles do exist in Keytruda’s winning strides as well.

 

Reimbursement is an issue as the insurance benefit is only approved for two indications, as second-line treatment for melanoma and lung cancer.

 

The drug was not able to extend its scope of reimbursement since September 2017.

 

In MSD’s discussions with the health authorities to reimburse Keytruda as second-line treatment for lung cancer, its competitor, the ‘all-comer’ drug ‘Opdivo (nivolumab),’ took away a partial win by strategically narrowing its scope of reimbursement, however, Opdivo also had not seen much progress in expanding its reimbursement ever since.

 

The discussion for Keytruda’s reimbursement as first-line treatment in NSCLC has been ongoing for around 4 years now.

 

It took 9 attempts for the agenda to pass the Health Insurance Review and Assessment Service’s Cancer Disease Review Committee (CDRC) meeting, however, the committee still requested further revisions to be made to the cost-sharing plan.

 

With the burden of re-revisions in mind, MSD is waiting for the agenda to be put up for deliberation by the Drug Reimbursement Evaluation Committee.

 

With the negotiations for contract renewal of the Risk-sharing Agreement (RSA) also overlapping, Keytruda is now at its highest inflection point since its entry into the Korean market.

 

Due to its versatility, expanding the scope of reimbursement for Keytruda may indeed result in the creation of a budget-gobbling monster.

 

In every field, the industry always moves faster than the system.

 

Whether Keytruda will be able to continue making progress in the sea of unprecedented, advanced new drugs that are being introduced remains to be seen.