Merck Predicts Over 80 Potential Oncology Approvals Through 2028

Smith Collection/Gado/Getty Images

Smith Collection/Gado/Getty Images

Powered by its blockbuster checkpoint inhibitor Keytruda, Merck is forecasting a potential of more than 80 new regulatory approvals in oncology through 2028.

Smith Collection/Gado/Getty Images

Powered by its blockbuster checkpoint inhibitor Keytruda, Merck is forecasting the potential of more than 80 new regulatory approvals in oncology through 2028.

Merck showcased its oncology pipeline at the American Society of Clinical Oncology meeting in Chicago. The company presented data from nearly 120 abstracts in more than 25 cancer types. Over the past decade, Merck’s oncology pipeline has exploded, driven by Keytruda, which is predicted to become the world’s top-selling drug after AbbVie’s Humira loses patent protection next year.

At the ASCO presentation, Dean Y. Li, president of Merck Research Laboratories, reminded us that it’s only been a decade since Phase I data for the drug that would become Keytruda was first presented.

“Since that time, we have created a broad portfolio of oncology medicines with indications in 22 tumor types and have helped usher in a new era of cancer treatment – and most importantly, have helped patients all around the world. With our expansive portfolio and pipeline, we are continuing to help transform care for patients with cancer and hope to receive more than 80 approvals through 2028,” Li said in a statement.

The company highlighted more than 20 investigational candidates targeting multiple aspects of cancer cell biology and immune-based pathways across four distinct research areas. For immuno-oncology, Merck pointed to three ongoing Phase III programs assessing favezelimab, an anti-LAG-3 antibody; quavonlimab, an anti-CTLA-4 antibody; and vibostolimab, an anti-TIGIT antibody. Each of these is being assessed in combination with Keytruda. Also in this space, Merck is developing an anti-ILT-4 antibody, an anti-ILT-3 therapy, and a selective IL-2 agonist.

Antibody-drug conjugates are also being explored by Merck. The company has multiple programs in development, including the Phase III zilovertamab vedotin being assessed in tumors that express elevated levels of receptor tyrosine kinase-like orphan receptor 1. Another ADC in development in collaboration with Seagen is ladiratuzumab vedotin, which is designed to target tumors expressing LIV-1, a zinc transporter protein.

The company is also developing cell-based therapies and T-cell and NK cell engagers for the treatment of different forms of cancer. Merck said that in collaboration with Dragonfly Therapeutics and Janux Therapeutics, it is assessing bi- and tri-specific NK and T-cell engagers. The company is also evaluating allogeneic cell therapies through our collaborations with Artiva and A2 Biotherapeutics.

The fourth area of research is molecularly targeted therapeutics. The company noted that Welireg, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor that was approved last year for the treatment of certain von Hippel Lindau-associated tumors, is being studied in multiple settings, including renal cell carcinoma.

Merck is also developing nemtabrutinib, a selective, oral, reversible non-covalent Bruton’s tyrosine kinase inhibitor, and a small molecule KRAS G12C inhibitor for the treatment of hematological cancers and solid tumors, respectively. Through its 2020 collaboration with Seagen, the company is also studying Tukysa, a tyrone kinase inhibitor, for the treatment of HER2-positive cancers.

Outside of oncology, Merck posted new post-hoc data for its antiviral drug Lagervio (molnupiravir) that showed a lower proportion of COVID-19 trial participants who were treated with the medication required an acute care visit. Fewer patients needed respiratory interventions, the company noted.

Lagevrio received Emergency Use Authorization from the FDA at the end of 2021. It was greenlit for the treatment of mild to moderate COVID-19 infections in adults who are at high risk of progression to severe disease. However, due to some efficacy issues, the FDA EUA limited use of the medication to situations where other treatment options for COVID-19 are not available or clinically appropriate,

The data announced this morning from the Phase III Move-Out study, which assessed the medication in non-hospitalized adults with mild to moderate COVID-19, showed that only 7.2% of patients who received the antiviral required an acute care visit. That was in comparison to 10.6% of placebo patients. Additionally, for those who did require hospitalization, Merck noted that trial data showed patients who received Lagevrio required a shorter stay than those in the placebo group, or nine days compared to 12.

“The analyses add to our understanding of the clinical profile of Lagevrio and help to reinforce the importance of Lagevrio as part of the response to the COVID-19 pandemic,” Li said in a statement.

Lagevrio is also being assessed in a Phase III trial as a prophylaxis treatment for COVID-19.