Merck MRK announced that the FDA has granted breakthrough therapy designation (BTD) to sacituzumab tirumotecan (sac-TMT) for the treatment of certain patients with non-small cell lung cancer (NSCLC).
The FDA has granted BTD to sac-TMT for treating patients with advanced or metastatic non-squamous NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations, whose disease has progressed on or after tyrosine kinase inhibitor and platinum-based chemotherapy.
The FDA grants BTD to expedite the development and review of therapies for severe or life-threatening diseases where preliminary clinical evidence shows that therapy may provide substantial improvements over available treatments. The agency’s decision to grant the designation is supported by positive data from two mid-stage studies on the drug in EGFR-mutated NSCLC patients.
Per Merck, this is the first BTD granted by the FDA to sac-TMT. Apart from NSCLC, Merck has been also evaluating the drug in 10 late-stage studies across various solid tumors. A TROP2-targeted antibody-drug conjugate (ADC), sac-TMT, is being developed by Merck in collaboration with China-based Kelun-Biotech. Per the terms, MRK holds exclusive rights to market the drug globally, except in Greater China, where the rights have been retained by Kelun-Biotech.
Currently, the drug is only approved in China for certain patients with triple-negative breast cancer. It is yet to be approved for any indication in the United States.
MRK Stock’s Price Performance
Year to date, Merck’s shares have lost 6.6% against the industry’s 9.3% growth.
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MRK Faces Stiff Competition in the ADC Space
Through the Kelun deal (signed in 2022), Merck forayed into the ADC space, which has garnered interest from other big pharma like AstraZeneca AZN, AbbVie ABBV and Pfizer PFE. All these companies have made multi-billion-dollar investments in this space to develop and market novel ADC drugs.
To further explore the ADC space, Merck signed a deal with Daiichi Sankyo last year to jointly develop and market three investigational ADC drugs for a total potential consideration of up to $22 billion. MRK’s deal with Daiichi involves three ADCs, namely patritumab deruxtecan, ifinatamab deruxtecan and raludotatug deruxtecan, which are across multiple solid tumor indications in different stages of clinical development. Per Merck, this deal holds multi-billion dollar worldwide commercial revenue potential for each company approaching the mid-2030s.
AstraZeneca markets Enhertu, which is currently the only ADC drug in its portfolio. This drug has been developed in collaboration with Daiichi Sankyo. Since its initial launch in 2019, Enhertu has shown an impressive initial uptake. The AZN drug is presently approved across multiple indications, including advanced or metastatic HER2-positive gastric cancer, previously treated HER2-mutant metastatic NSCLC and metastatic HER2-positive and HER2-low breast cancer. The fifth indication, metastatic HER2-positive solid tumors, was approved by the FDA in April.
AbbVie forayed into the ADC space following the acquisition of ImmunoGen which was completed in February. As part of this deal, management acquired Elahere, a first-in-class ADC approved for ovarian cancer indication. Apart from Elahere, the ImmunoGen acquisition also added some other promising ADC candidates in AbbVie’s pipeline, like pivekimab sunirine (in phase II studies for blastic plasmacytoid dendritic cell neoplasm and acute myeloid leukemia) and IMGN-151 (in phase I studies for ovarian and endometrial cancers).
Pfizer entered into this space when it acquired ADC drugmaker Seagen last year for $43 billion. Post this acquisition, PFE added three ADCs to its portfolio — Adcetris (brentuximab vedotin), Padcev (enfortumab vedotin) and Tivdak (tisotumab vedotin) — all approved across solid tumors and hematologic malignancies. Per the terms of the deal, Pfizer also acquired Seagen’s proprietary ADC technology.
Merck & Co., Inc. Price
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MRK’s Zacks Rank
Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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