NEW YORK – Amgen reported record sales of Blincyto (blinatumomab) in the third quarter of 2023, reflecting increased use of the immunotherapy throughout the year in CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL).
Blincyto contributed $220 million to Q3 2023 revenues, up 55 percent from $142 million in Q3 2022. According to Murdo Gordon, Amgen executive VP of global commercial operations, sales of the drug were buoyed by positive data from the Phase III ECOG-ACRIN E1910 trial in BCR-ABL-negative B-ALL and the National Comprehensive Cancer Network recommending the drug for pediatric B-ALL patients. Gordon added that the company expects Blincyto sales to increase even more as it is taken up in earlier lines of therapy.
Blincyto is approved in the US for pediatric and adult patients with CD19-positive B-ALL who have had a first or second complete remission with minimal residual disease of at least 0.1 percent. In June, the US Food and Drug Administration granted the drug full approval for treating relapsed or refractory CD19-positive B-ALL in adults and children.
In Europe, Blincyto is also approved for these indications, but patients must also have Philadelphia chromosome (Ph)-negative B-ALL.
In December 2022, Amgen reported results from the E1910 trial showing that patients with Ph-negative BCR-ABL-negative B-ALL had not yet reached median overall survival at a median follow-up time of 43 months compared to 71.4 months for those on consolidation chemotherapy. Patients in the Blincyto arm also had not reached median relapse-free survival compared to patients on chemotherapy who lived for a median 22.4 months before relapsing.
Amgen's overall revenues in Q3 2023 increased 4 percent to $6.90 billion compared to $6.65 billion in the year-ago quarter and above the consensus Wall Street estimate of $6.62 billion. For the three months ended Sept. 30, Amgen's product sales were $6.55 billion, up 5 percent compared to $6.24 billion in Q3 2022.
In addition to Blincyto, Amgen's precision oncology product portfolio also includes Lumakras (sotorasib), a treatment for KRAS G12C-mutated advanced non-small cell lung cancer, which has been approved in 50 countries. The KRAS inhibitor contributed $52 million to Q3 2023 revenues, down 31 percent from $75 million in Q3 2022. Gordon attributed the lower sales to "ongoing reimbursement negotiations in France," adding that the company sees "future growth opportunities for Lumakras driven by launches, new markets, and our comprehensive global clinical development program."
Last week, Amgen announced plans to discuss results from the CodeBreaK 300 trial with regulators for potential approval of Lumakras with the EGFR-inhibiting monoclonal antibody Vectibix (panitumumab) as a treatment for patients with KRAS G12C-mutant metastatic colorectal cancer. In the trial, median progression-free survival was 5.6 months for patients on Vectibix and the highest dose of Lumakras compared to 2.2 months on investigator's choice of treatment.
Sales of Vectibix, which is sold as a treatment for RAS wild-type colorectal cancer, increased 2 percent during Q3 2023 to $252 million versus $247 million in Q3 2022. Murdo said record sales of the drug were attributable to a higher net selling price and 4 percent volume growth, partially offset by the unfavorable impact of foreign currency exchange rates.
The firm recorded net income of $1.73 billion, or $3.22 per share, compared to $2.14 billion, or $3.98 per share, in Q3 2022. On a non-GAAP basis, the company reported EPS of $4.96; on average, analysts had expected EPS of $4.39.
In 2023, the company is expecting total revenue to be in the range of $28.0 billion to $28.4 billion and EPS between $11.23 and $12.73, or between $18.20 and $18.80 on a non-GAAP basis.
As of Sept. 30, Amgen had $34.74 billion in cash and cash equivalents.