Oncology Pipeline Touted at Merck Investor Day

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During an investors’ day conference on Thursday morning, Merck Chief Commercial Officer Frank Clyburn pointed to the growth opportunities ahead of the company in oncology due to the strength of three medications. Merck has the potential to see regulatory approval for more than 50 additional indications in oncology over the next five years for Keytruda, Lynparza and Lenvima. Over the next decade, Mike Nally, Merck’s chief marketing officer, said the company will be the leader in oncology due to its efforts in this field. Nally said the company has the largest immuno-oncology pipeline in the industry and only sees that leading to the company’s continued leadership in this area.

Ahead of the investors’ day, the first in five years for the company, there were some analysts who expressed concern over the company’s reliance on Keytruda. However, from the presentations this morning, it’s clear that Keytruda will remain a tent pole medication for the company for the foreseeable future. Six years after it was launched, Keytruda is one of the best-selling drugs in the world. Last year, it generated more than $7 billion in revenue and that is only predicted to grow, particularly as the drug wins approval for new indications. Over the next five years, Clyburn said Keytruda’s approved indications are expected to more than double with approvals as part of new combinations and in different stages of therapy, including adjuvant and neoadjuvant. Keytruda recently picked up two new approvals from the FDA. And, more are expected to come.

During the presentation, Clyburn said there are significant growth opportunities for Keytruda in multiple cancers. He said Keytruda is a “significant cornerstone” for long-term growth at Merck.

“In a short time, Keytruda has become a foundational cancer treatment. We have activity across 25 different cancer types… and Keytruda is changing the way in which patients are being treated today,” Clyburn said.

Roy Baynes, Merck’s head of global clinical development, concurred with Clyburn. He said Keytruda is still in the early stages of development and is part of more than 1,000 clinical trials. With the ongoing trials, Baynes said the company is building a “wall of data” around Keytruda.

Lynparza, the PARP inhibitor co-developed with AstraZeneca, and Lenvima are also expected to be strong contributors to the company’s oncology future. With Lynparza, Clyburn said there are growth opportunities across multiple tumor types. He noted that Lynparza has class leadership in the U.S., with nearly 60% of total PARPi prescriptions. Following strong Phase III results in pancreatic cancer, the first time a PARP inhibitor demonstrated activity in germline BRCA-mutated metastatic pancreatic cancer, Merck and AstraZeneca plan to seek regulatory approval. With Lenvima, a multiple receptor tyrosine kinase inhibitor approved for renal cell carcinoma and hepatocellular carcinoma (HCC), Merck sees significant growth opportunities in China, where HCC is prevalent.

Merck’s vaccine business is also a key to growth. Clyburn said global leaders keep telling him are essential to answering ongoing health concerns across the world. Since 2010, Merck has doubled its vaccine business and Clyburn said it will continue to grow. One of the key drugs in its vaccine portfolio is Gardasil, a treatment for human papillomavirus. Gardasil is seeing increased growth driven by global appeals to eliminate cervical cancer. Less than 3% of the world has received an HPV vaccine, so Merck sees significant opportunities for growth there, Clyburn said.

HIV treatments are also key to future growth at Merck. Last year, the company won approval for two new HIV treatments, Delstrigo, a once-per-day triple combination treatment, and Pifeltro, a new non-nucleoside reverse transcriptase inhibitor. Merck also has a promising clinical candidate that could be a game changer in HIV treatment. Nally pointed to MK8591 as a future backbone treatment for HIV due to its efficacy and long half-life that could allow for weekly, or even monthly dosing.

“This compound has a real potential to fundamentally change the transmission dynamics of HIV patients,” Nally said.

Merck Chief Executive Officer Ken Frazier touted Merck’s team and its abilities to deliver potent therapies to patients across multiple diseases. He called it a team sport to bring a drug through the clinic and to market. He said Merck has a strong team to “do this on a repeated basis.”  He pointed to the company’s desire to “follow the science,” which not only transforms treatment options but also the company as well. Since Merck’s last investor day held five years ago, he said no one thought of Merck as an oncology company. But thanks to Keytruda, Merck is a “leader in immuno-oncology because they have been willing to evolve depending on where the science took us.”