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Lumakras Sales More Than Double in Q3 2022 as Amgen's Overall Revenues Decline 1 Percent

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NEW YORK – Sales of Amgen's KRAS inhibitor Lumakras (sotorasib) more than doubled during the third quarter of 2022 compared to the year-ago period, the drugmaker reported after the markets closed on Thursday.

During the three-month period ending Sept. 30, revenue from Lumakras more than doubled to $75 million for the Thousand Oaks, California-based drugmaker compared to $36 million during Q3 2021. The growth speaks to the increasing uptake for the drug, which nabbed the US Food and Drug Administration's approval as a treatment for KRAS G12C-mutated non-small cell lung cancer patients in May 2021. Since then, Lumakras has been approved in 45 other countries, and Amgen is actively launching it in 30 markets.

"Our oncology teams around the world are doing a very nice job of identifying … second-line patients [with KRAS G12C mutations] and making sure they have Lumakras as a treatment option," said Murdo Gordon, Amgen's executive VP of global commercial operations, during a call to discuss Amgen's Q3 financial results. In the US, Amgen said Lumakras has now been prescribed to more than 3,700 patients.

Sales of another Amgen precision oncology medicine, Vectibix (panitumumab), for RAS wild-type colorectal cancer, also increased 24 percent during Q3 2022 to $247 million versus $200 million during the same period in 2021. Blincyto (blinatumomab), a treatment for patients with CD19-positive B-cell precursor acute lymphoblastic leukemia, contributed $142 million in Q3 2022, up 14 percent from $125 million in Q3 2021.

Overall, Amgen's product sales during Q3 of this year totaled $6.24 billion, a 1 percent drop from $6.32 billion during the same period last year. Total revenues were $6.65 billion in Q3 2022, also a 1 percent dip from $6.71 billion in Q3 2021. On average, analysts had expected revenues of $6.56 billion.

During Thursday's call, David Reese, Amgen's executive VP of R&D, reflected on a series of studies presented during Q3 that collectively support Lumakras' benefit in NSCLC and other KRAS G12C-mutated cancers.

At the European Society for Medical Oncology Congress in September, for instance, Amgen presented data from the Phase III CodeBreaK-200 trial, which pitted Lumakras against chemotherapy as treatment for KRAS G12C-mutated NSCLC patients. In that trial, the one-year progression-free survival rate for patients receiving Lumakras was 24.8 percent versus 10.1 percent among patients receiving chemotherapy.

Of note, that trial did not show a clear overall survival benefit with the drug, which disappointed oncologists even though the trial wasn't powered to assess overall survival, and crossover from one arm to the other after disease progression may have skewed results.

The firm also touted data from the KRAS G12C-mutated metastatic colorectal cancer cohort of the Phase I/II CodeBreaK-101 study, in which 30 percent of 40 evaluable patients responded on Lumakras and Vectibix. The disease control rate, which included both tumor responses and stable disease, was 93 percent.

According to Reese, Amgen is planning to initiate a Phase III trial evaluating Lumakras plus chemotherapy as a treatment for first-line KRAS G12C-mutated advanced NSCLC patients whose tumors are PD-L1-negative.

The firm also shared that it has just received initial top-line data from a post-market study that compared the currently approved dose of Lumakras with a lower dose for KRAS G12C-mutated NSCLC. Though it was too early to present the exact findings from that study, Reese said that Amgen plans to submit the data to the FDA along with confirmatory Phase III data from CodeBreaK-200.

During the call, Amgen executives also provided updates on other marketed and experimental drugs in its pipeline. For example, a registration-directed trial of Blincyto for treatment-naïve Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia met its primary endpoint and showed statistically significant improvements in overall survival compared to chemotherapy. Amgen will present this data at a medical conference later this year and submit it to regulators.

The firm is also enrolling patients into studies involving its FGFR2b-targeted therapy bemarituzumab. Amgen is evaluating the treatment in combination with other drugs and involving patients with FGFR2b-overexpressing gastric cancer and squamous NSCLC. One trial, FORTITUDE-301, is a tumor-agnostic basket study evaluating bemarituzumab in FGFR2b-overexpressing solid tumors.

The firm also continues to enroll patients with advanced MTAP-null solid tumors into a Phase I/Ib/II study of the PMRT5 inhibitor AMG 193.

In Q3 2022, Amgen posted net income of $2.14 billion, or $3.98 per share, versus $1.88 billion, or $3.31 per share, in Q3 2021. On an adjusted basis, Amgen's EPS was $4.70. On average, analysts had expected EPS of $4.44.

The firm's R&D expense decreased by 22 percent to $1.11 billion in Q3 2022 compared to $1.42 billion in the year-ago quarter. Over the same period, selling, general, and administrative expenses dipped 1 percent to $1.29 billion compared to $1.31 billion.

At the end of the quarter, Amgen held $11.48 billion in cash, cash equivalents, and marketable securities.