Top Performing Drug of 2021 - Keytruda (May Edition)

Active Ingredients: Pembrolizumab

Strength: 100 mg/4 mL (25 mg/mL)

Dosage Form: Syringe, Vial

Mechanism of Action: PD-1 ligands antagonists

First Approval: US (Sep 4, 2014), EU (Jul 17, 2015)

Revenue

Keytruda (pembrolizumab) has been a key player in Merck & Co. immuno-oncology drugs for the past years – reaching nearly $17B in annual sales in 2021. Despite the dampening impact of Covid-19, Keytruda’s global sales grew 20% in 2021, 30% in 2020, and 55% in 2019 due to higher demand as it continued to launch with multiple new indications globally. Let’s see in what manner the revenue of Keytruda changes over the last five years.¹

Approved Indications for Keytruda

Keytruda is approved and marketed in the US and Europe for various indications including²:

Melanoma: Unresectable or metastatic melanoma
Non-Small Cell Lung Cancer: NSCLC expressing PD-L1

Keytruda + pemetrexed and pt-CT: metastatic non-squamous NSCLC
Keytruda + carboplatin: metastatic squamous NSCLC

Head and Neck Squamous Cell Cancer: metastatic or unresectable, recurrent HNSCC, tumors that express PD-L1
Classical Hodgkin Lymphoma: relapsed or refractory cHL
Primary Mediastinal Large B-Cell Lymphoma: refractory primary mediastinal large B-cell lymphoma (PMBCL)
Urothelial Carcinoma: advanced or metastatic urothelial carcinoma
Microsatellite Instability-High or Mismatch Repair Deficient Cancer: unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors
Gastric Cancer: Keytruda + trastuzumab, fluoropyrimidine + pt CT for unresectable or metastatic HER2+ gastric/GEJ adenocarcinoma
Esophageal Cancer: advanced or metastatic oesophageal/GEJ carcinoma
Cervical Cancer: recurrent, or metastatic cervical cancer whose tumors express PD-L1
Hepatocellular Carcinoma: patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib
Merkel Cell Carcinoma: advanced or metastatic Merkel cell carcinoma
Renal Cell Carcinoma: Keytruda + axitinib for advanced renal cell carcinoma (RCC)
Endometrial Carcinoma: Keytruda + Lenvatinib for advanced endometrial carcinoma
Tumor Mutational Burden-High Cancer: unresectable or metastatic tTMB-H (mut/Mb) solid tumors
Cutaneous Squamous Cell Carcinoma: recurrent or metastatic cSCC
Triple-Negative Breast Cancer: recurrent unresectable or metastatic TNBC whose tumors express PD-L1

Clinical Trials

Keytruda has a total of 1890 trials³ which included 1208 industry trials of which 1191 were interventional, 16 observational⁵ & 1 expanded access trial⁶. From the analysis of clinical trials, we have made a representation for the trials of Keytruda.

*Active trials include Recruiting; Active, Not Recruiting; Enrolling by Invitation, and suspended

*Inactive trials include Terminated; Withdrawn; Unknown Status

*Planned trials include Not yet recruiting

THE MERCK ACCESS PROGRAM

1. Coverage & reimbursement support

The Merck Access Program helps patients to understand the benefits of investigation, prior authorization, and appeal process

2. The Merck Co-pay Assistance Program

It offers assistance to eligible, privately insured patients who need help affording the out-of-pocket costs for KEYTRUDA.

Once enrolled, eligible, privately insured patients pay the first $25 of their co-pay per infusion
Maximum co-pay assistance program benefit is $25,000 per patient, per calendar year

3. The Merck patient Assistance program

The program helps patients who do not have insurance or whose insurance does not cover KEYTRUDA may be eligible for free products from the Merck Patient Assistance Program if they meet certain financial and medical criteria.

4. The Merck KEY+YOU program

It is designed for patients prescribed KEYTRUDA for an approved indication. Educational resources are provided to patients and caregivers to understand treatment with KEYTRUDA and be more active and vocal

Please visit the Cost info & financial help section on www.keytruda.com and Merck Patient Assistance Program for more information⁷

Keytuda Pipeline Analysis

In 2021, Keytruda received approval for additional indications in the U.S. and internationally as monotherapy in the therapeutic areas of breast, colorectal, cutaneous squamous cell, oesophageal, melanoma, and renal cell cancers, + CT in the therapeutic areas of breast, cervical, gastric or gastroesophageal junction cancers. Keytruda + Lenvima was approved for the treatment of endometrial and renal cell cancer. Various trials are ongoing for other indications. This can be categorized as follows:

Other Information⁸

Patent protection is important material importance to the company for its discovery, development, manufacturing and marketing of its products. Patented products provide market exclusivity and profitability to the company. Keytruda is among the blockbuster drugs for Merck. Merck’s patent exclusivity on Keytruda will expire in 2028 that can bring a risk to Merck’s oncology portfolio.

Merck has created a patent wall for Keytruda which has 53 granted patents and 129 patent applications. The estimated purchasing cost of branded Keytruda is at least $137B during the eight years of extended exclusivity
The patents applications of Keytruda are divided as follows:

34 primary patents (product patents) for pembrolizumab which covers antibody, antibody fusion proteins, and vectors.
The remaining 95 applications are secondary patents. They are classified as:
~52 patents are applications on Keytruda that cover various methods of production and process its manufacturing
~34 patent applications are for methods of treatment, covering the 18 different cancer types
~4 patent applications are covered each for biomarkers and diagnosis. ~3 patents are covered by a formulation that includes inactive ingredients and processes of combining them with the antibody pembrolizumab

References:

1. https://d18rn0p25nwr6d.cloudfront.net/CIK-0000064978/adb74fbd-102d-4352-8aa7-d24d7159858e.pdf

https://d18rn0p25nwr6d.cloudfront.net/CIK-0000064978/4df43d8f-8b85-45da-92ef-7ad82f343c3b.pdf

https://d18rn0p25nwr6d.cloudfront.net/CIK-0000064978/75a322e0-ce26-478b-954f-5da950e9d365.pdf

https://d18rn0p25nwr6d.cloudfront.net/CIK-0000064978/463d7226-df90-49f3-a16d-b010cdcc1c75.pdf

https://d18rn0p25nwr6d.cloudfront.net/CIK-0000310158/357ac382-9a56-4879-bce6-6a4b7fb87e58.pdf

2. https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf

3. https://clinicaltrials.gov/ct2/results?term=keytruda&age_v=&gndr=&type=&rslt=&fund=2&Search=Apply

4. https://clinicaltrials.gov/ct2/results?term=keytruda&age_v=&gndr=&type=Obsr&rslt=&fund=2&Search=Apply

5. https://clinicaltrials.gov/ct2/results?term=keytruda&age_v=&gndr=&type=Obsr&rslt=&fund=2&Search=Apply

6. https://clinicaltrials.gov/ct2/results?term=keytruda&age_v=&gndr=&type=Expn&rslt=&fund=2&Search=Apply

7. https://www.keytruda.com/