Amgen clinches clinical wins in SCLC and colorectal cancer
Amgen clinches clinical wins in SCLC and colorectal cancer
Published: Aug 04, 2023
By Tristan Manalac
BioSpace
Two of Amgen’s oncology assets claimed mid-stage and late-stage clinical victories, the company announced Thursday in its second-quarter earnings report.
Without providing specific data, Amgen reported that its investigational bispecific T-cell engager (BiTE) tarlatamab led to “durable objective response rate” in patients with relapsed or refractory small cell lung cancer (SCLC) who had failed at least two prior lines of treatment. The Phase II study, dubbed DeLLphi-301, also found that tarlatamab’s safety profile was “more favorable” compared to its Phase I study and identified no new signals of concern.
Amgen will take these “potentially registrational data” to regulatory agencies to determine the best regulatory path forward for tarlatamab, according to the announcement. The company has also launched a Phase III SCLC study for the BiTE candidate, dubbed DeLLphi-304, in the second-line setting and plans to initiate two more late-stage studies in earlier lines of SCLC.
Results from DeLLphi-301 will also be presented at an upcoming medical congress.
Amgen also revealed in its second-quarter earnings report that the company’s KRAS inhibitor Lumakras (sotorasib) met its primary endpoint in the global Phase III CodeBreak 300 study. When combined with Vectibix (panitumumab), Lumakras significantly improved progression-free survival in patients with chemorefractory metastatic colorectal cancer harboring the KRAS G12C mutation, as compared with current standard of care.
The company again did not present specific data but promised to do so at an upcoming medical congress. Amgen will also discuss these data with regulatory authorities to assess a potential label expansion for Lumakras.
First approved in May 2021, Lumakras works by forming irreversible covalent bonds with the mutated KRAS, thereby keeping the protein in its inactive form and preventing the cancer cells from growing further. The drug is used to treat non-small cell lung cancer, for which it competes with Mirati’s Krazati (adagrasib), which won the FDA’s approval in December 2022.
In the second quarter, Lumakras brought Amgen $77 million in sales, representing no change from the same period in 2022. According to the company, this flat trend was driven by a lower net selling price and inventory levels, which offset 20% growth in volume. Its recent Phase III win could set Lumakras up for a label expansion and push the drug into a new therapeutic space to boost its sales numbers.
Despite stagnant sales from Lumakras, Amgen posted a 6% increase in total revenues, which reached $7 billion in the quarter. A similar 6% jump in product revenues accounted for this revenue growth, particularly from its cardio asset Repatha (evolocumab) and menopausal osteoporosis medicine Evenity (romosozumab), sales of which increased by 30% and 47%, respectively.
Source: BioSpace
