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Amgen Highlights Positive Phase III Lumakras Data in Colorectal Cancer Amid Flat Q2 Sales


NEW YORK – Although Amgen reported flat year-over-year sales for its KRAS inhibitor Lumakras (sotorasib) during Q2 2023, the company is making headway in identifying other indications in which the drug can benefit cancer patients.

The Phase III CodeBreak 300 trial, in which researchers are testing the efficacy of Lumakras and the EGFR-inhibiting monoclonal antibody Vectibix (panitumumab) in chemo-refractory, metastatic, KRAS G12C-mutated colorectal cancer, met its primary endpoint of progression-free survival, Amgen executives said Thursday afternoon during a conference call to discuss Q2 2023 financial results.

In the trial, Amgen is comparing Lumakras-Vectibix against investigator's choice of therapy, either Taiho Pharmaceuticals' nucleoside antitumor agent Lonsurf (trifluridine/tipiracil) or Bayer's multikinase inhibitor Stivarga (regorafenib), in previously treated patients with KRAS G12C-mutated colorectal cancer. David Reese, Amgen's executive VP of R&D, said during the call that the company plans to discuss the positive results from this trial with global regulatory authorities and present the findings at an upcoming medical conference.

The positive data further Amgen's ambitions to grow the market for Lumakras, which is already approved in the US and other countries as a treatment for KRAS G12C-mutated advanced non-small cell lung cancer. Reese highlighted Amgen's plans to initiate a Phase III trial of Lumakras with chemotherapy in first-line KRAS G12C-mutant and PD-L1-negative advanced or metastatic non-small cell lung cancer in Q3 and test Lumakras-Vectibix plus chemotherapy in the first-line KRAS G12C-mutated colorectal cancer setting in a future Phase III trial. However, Reese said Amgen is discontinuing enrollment in a study where it was assessing Lumakras with a PD-1 inhibitor in KRAS G12C mutated NSCLC.

Lumakras generated $77 million in sales in Q2 2023, flat compared to Q2 2022. Amgen reported 77 percent volume growth for the drug during Q2 2023 compared to the year-ago period, but this was partially offset by a lower net selling price, Reese explained.

Amgen's overall revenues for the three months ended June 30 increased 6 percent to $6.99 billion compared to $6.59 billion in the year-ago quarter and were above the consensus Wall Street estimate of $6.68 billion. Over this same period, Amgen's product sales also increased 6 percent to $6.68 billion from $6.28 billion.

The firm on Thursday reported strong sales of several precision oncology products during the second quarter. Sales of Blincyto (blinatumomab), a treatment for patients with CD19-positive B-cell precursor acute lymphoblastic leukemia, including those who are in first or second complete remission and are minimal residual disease negative, contributed $206 million to Q2 2023 revenues, up 48 percent from $139 million in Q2 2022. 

In late 2023 or early 2024, Amgen is planning to seek approval in markets around the world for Blincyto as a treatment for patients with newly diagnosed B-lineage acute lymphoblastic leukemia who have no detectable minimal residual disease based on results from the Phase III E1910 trial. The company is also studying the drug in earlier lines of treatment and as a subcutaneous injection.

"Blincyto sales grew 48 percent year over year, with adoption across academic, community, and pediatric [cancer] centers following positive data from the registration-enabling E1910 study presented in December 2022 and updated NCCN guidelines that were issued in May," Murdo Gordon, executive VP of global commercial operations for Amgen, said on the call. "Both the positive data and the updated guidelines support our confidence in the continued growth potential for Blincyto."

Sales of Vectibix, a treatment for RAS wild-type colorectal cancer, increased 20 percent to $248 million in Q2 2023 versus $207 million in Q2 2022.

The firm recorded net income of $1.38 billion, or $2.57 per share, compared to $1.32 billion, or $2.45 per share, in Q2 2022. On a non-GAAP basis, the company's EPS was $5.00; on average, analysts had expected $4.49 per share.

The company is expecting 2023 revenue to be between $26.6 billion and $27.4 billion and GAAP EPS in the range of $14.30 and $15.41, or between $17.80 and $18.80 on a non-GAAP basis. The guidance doesn't include the impact of Amgen's recent acquisition of Horizon Therapeutics, slated to close in mid-December.

As of June 30, Amgen had $34.2 billion in cash, cash equivalents, and marketable securities.