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Keytruda Revenue Climbs 20 Percent in Q3 as Merck Continues Push Into Earlier-Stage Cancer Settings


NEW YORK – Merck said on Thursday that sales of its blockbuster immune checkpoint inhibitor Keytruda (pembrolizumab) climbed 20 percent during the third quarter of 2022, bolstered by global triple-negative breast cancer demand and a shift into earlier cancer treatment settings.

During the three-month period ending Sept. 30, Keytruda brought in $5.43 billion for Merck compared to $4.53 billion in the third quarter of 2021. This contributed significantly to Merck's $12.96 billion in Q3 pharmaceutical sales, a 13 percent increase versus $11.49 billion in pharmaceutical sales during the prior year's third quarter.

On the whole, Merck's revenues were up 14 percent, rising to $14.96 billion in Q3 2022 versus $13.15 billion in Q3 2021.

Merck posted a Q3 profit of $3.25 billion, or $1.28 per share, compared to $4.57 billion, or $1.80 per share, for the third quarter of 2021. On an adjusted basis, its EPS was $1.85 versus $1.78 in the comparable period of 2021.

In a conference call to discuss the third-quarter results on Thursday morning, Merck CFO Caroline Litchfield reflected on several of Keytruda's growth drivers.

"There continues to be very strong demand in neoadjuvant, adjuvant, high-risk, early-stage triple-negative breast cancer, a testament to the profound effect Keytruda is having on patients with this aggressive form of disease," Litchfield said.

The US Food and Drug Administration approved Keytruda for this early TNBC indication in July 2021, and the European Commission followed suit in May of this year. Both regulatory bodies based their approvals on results from the Phase III KEYNOTE-522 trial. Litchfield emphasized this indication above others since it reflects Merck's overall push to move the drug from later-stage disease to earlier indications.

Keytruda saw a strong third quarter in terms of regulatory approvals outside the US. In September, Japan's Ministry of Health, Labor, and Welfare approved the drug for four indications including for certain patients with TNBC, kidney cancer, cervical cancer, and melanoma.

Sales of Merck's PARP inhibitor Lynparza (olaparib) — a drug it shares with AstraZeneca — also grew during Q3 2022. Merck's share of Lynparza profits climbed 16 percent to $284 million versus $246 million during the third quarter of 2021.

The growth reflects continued uptake for Lynparza among patients with early-stage breast cancer; in August and September, the PARP inhibitor garnered approvals in the EU, Japan, and the UK for this high-risk, early-stage breast cancer indication, specifically among patients harboring BRCA mutations.

Outside breast cancer, Merck is hoping Lynparza nets approval for metastatic castration-resistant prostate cancer (mCRPC) in combination with hormone therapy and a steroid based on the results of the Phase III PROpel trial. The FDA granted priority review for this application and is expected to make a decision during the fourth quarter of this year. Lynparza is already approved for previously treated mCRPC patients whose cancers harbor BRCA mutations or other homologous recombination repair gene mutations, but the pending approval would expand the drug into the all-comer population and move it up to the first-line treatment setting.

Looking ahead, Merck underscored that its expected oncology growth also centers on combination strategies and strategic partnerships. For instance, earlier this month, Merck exercised its option to jointly develop and commercialize Moderna's personalized cancer vaccine, mRNA-4157/V940, combined with Keytruda as a melanoma treatment.

Moderna is already conducting a randomized Phase II study of the vaccine-immunotherapy combo with the aim of evaluating the combination's efficacy versus Keytruda alone in the adjuvant treatment setting for high-risk melanoma.

"We are energized to continue our collaboration with Moderna, a pioneer of mRNA vaccine technology," Dean Li, president of Merck Research Laboratories, said on the Thursday conference call. According to Li, melanoma is the starting point for this combination, but Merck hopes to expand into other tumor types and different stages.

Li also pointed out Merck's push to develop a version of Keytruda that can be administered as a subcutaneous injection, as opposed to an intravenous infusion as it is now. The firm is currently evaluating this new formulation compared to the current IV version in a Phase III clinical trial for non-small cell lung cancer.

Li spoke to how this approach could expand Keytruda access, making the drug available outside of infusion centers.

"The critical thing for patients, especially in the early stage, is to be able to have really excellent access to our medicines, and there is a need for scientific innovation," Li said. "That is why we're advancing the subcutaneous program, and … we are confident in our strategy."

Beyond improving access by removing the intravenous barrier, there is also a strong business motive for the shift toward subcutaneous immunotherapy; Keytruda's patents are set to begin expiring in 2028, and a new formulation could extend exclusivity for a drug that is, far and away, Merck's largest profit-driver.