Zilovertamab vedotin

Merck's phase 3 lineup is continuing to grow, thanks in large part to dealmaking. After more than 20 phase 3 trials got underway in 2023, Merck is planning for even more this year, according to Dean Li, Ph.D., head of Merck Research Labs, on Thursday. Meanwhile, CEO Rob Davis says the company is hunting for more midsized deals.  Three new assets entered phase 3 trials in the fourth quarter, all three of which came from business development. MK-1022 is the most recent, coming over in Merck’s multibillion-dollar deal with Daiichi Sankyo announced in the fall. Candidates stemming from Merck’s licensing deal with Kelun and 2022 acquisition of Imago also entered phase 3 studies.  The advancement of programs stemming from deals only reinforces Davis’ continued commitment to business development, which he affirmed yet again on Thursday. In the last 12 months, Merck has acquired preclinical biotech Caraway Therapeutics, plus Prometheus Biosciences and Harpoon Therapeutics, each providing a different therapeutic area. All these moves are part of Merck’s larger diversification strategy to assuage investor concerns about Keytruda’s 2028 patent expiration.  “We do continue to believe we need more and we will continue to prioritize business development,” Davis said on the Thursday earnings call. Davis reiterated that Merck is interested in deals between $1 billion and $15 billion, with the $10 billion-plus range being the sweet spot. The likes of Prometheus and Acceleron fell in this range, and that's “still the size of deals we are very interested in,” he said. For comparison, Merck’s foray into T-cell engagers through last month’s Harpoon buy cost the biotech $680 million.  Recent acquisitions and partnerships contributed to Merck’s ballooning R&D spend in 2023, which exceeded a whopping $30 billion in GAAP expenses. But when you subtract charges stemming from deals with Daiichi, Prometheus and Imago, the total falls to $13.6 billion, $100 million more than the 2022 total, and about 23% of 2023 sales.  Still, Merck is trimming around the edges of its pipeline, including external assets. Gone from the company’s phase 1 pipeline is MK-0482, which was in development for non-small cell lung cancer as recently as the third quarter. Clinical trial records show that the company terminated a phase 1 study in patients with leukemia at the beginning of the year for “business reasons.” A Merck spokesperson said the company elected to discontinue the program as part of Merck's "routine pipeline prioritization."  Merck is also narrowing the use of an antibody-drug conjugate acquired from VelosBio to focus solely on hematological malignancies. Earnings documents from the third quarter show that MK-2140 was being tested in a handful of solid tumors as well, but they’re now no longer listed alongside the asset. The spokesperson said "we’re continuing to evaluate the best path forward."  Editor's note: This story was updated with comments from a Merck spokesperson and to correct the year Merck announced its acquisition of Imago BioSciences. 

AbbVie’s epcoritamab is intended to treat adult patients with relapsed/refractory DLBCL. Credit: AbbVie Inc. AbbVie has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for epcoritamab (TEPKINLY) to treat adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The CHMP has recommended granting conditional marketing authorisation for epcoritamab as a single agent for this indication following two or more lines of systemic therapy. Recommended Reports Reports LOA and PTSR Model - Zilovertamab Vedotin in Follicular Lymphoma GlobalData Reports LOA and PTSR Model - Atezolizumab in Follicular Lymphoma GlobalData View all Companies Intelligence AbbVie Inc C H M P INC View all The investigational IgG1-bispecific antibody has been developed leveraging the DuoBody technology of Genmab. This technology directs cytotoxic T-cells selectively to obtain an immune response toward target cell types. The company’s application for epcoritamab approval was based on data from the pivotal EPCORE NHL-1 Phase I/II study. This multi-centre and open-label trial assessed epcoritamab’s preliminary efficacy and safety in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (NHL), including DLBCL. The overall response rate, evaluated by an independent review committee, was the trial’s primary endpoint. AbbVie haematology therapeutic area head and vice-president Mariana Cota Stirner stated: “We are pleased with the recent CHMP positive opinion for epcoritamab, as it represents an important step in our journey to develop a potential core therapy for people living with B-cell malignancies, such as DLBCL.” Epcoritamab is currently awaiting approval in the European Union (EU). Once approved, it will be marketed under the brand name TEPKINLY in all EU member states and in Iceland, Norway and Liechtenstein.