Pavurutamab

Headline results for the third quarter: Revenue: $6.9 billion, up 4% Product sales: $6.5 billion, up 5% Profit: $1.7 billion, versus $2.1 billion in the year-ago periodNote: All changes are versus the prior-year period unless otherwise statedWhat the company said:"We are excited about our pipeline progress and our operating performance in the third quarter. With the completion of the Horizon acquisition, Amgen has added rare disease medicines that fit well with our broad innovative portfolio," remarked Amgen CEO Robert Bradway.The company said earnings were negatively impacted by an impairment charge of roughly $650 million following a decision to discontinue development of AMG 340, a PSMAxCD3 bispecific T-cell engager (BiTE) it was evaluating for prostate cancer (see more below).Meanwhile, the company reported an overall 11% volume growth, primarily driven by double-digit gains for Blincyto, Evenity, Repatha, and Nplate. US volumes also increased by 11%, while ex-US volumes grew by 12%, with the Asia Pacific region experiencing 27% growth in volume.Other results: Enbrel: $1 billion, down 6% Prolia: $986 million, up 14% Otezla: $567 million, down 10%, with demand in the quarter continuing to be impacted by free drug programmes for newly launched competition Xgeva: $519 million, up 5% Repatha: $406 million, up 31%, with US sales up 29% to $183 million Kyprolis: $349 million, up 10% Aranesp: $323 million, down 10% Evenity: $307 million, up 53% Blincyto: $220 million, up 55% Mvasi: $213 million, up 2% Tezspire: $161 million, benefitting from the introduction of a self-administered, pre-filled, single-use pen approved by the FDA earlier this year Amgevita/Amjevita: $152 million, up 30% Neulasta: $124 million, down 50% Aimovig: $94 million, down 12% Lumakras/Lumykras: $52 million, down 31%, primarily influenced by adverse changes to estimated sales deductions linked to ongoing reimbursement negotiations in France Epogen: $50 million, down 63% Kanjinti: $20 million, down 72%Looking ahead:Amgen is now anticipating sales this year will come in between $28 billion and $28.4 billion, up from an earlier estimate of between $26.6 billion to $27.4 billion. It also lifted the lower end of its profit outlook by $0.40 and now expects to earn $18.20 to $18.80 per share.Pipeline update:Amgen said it ended a Phase I dose-escalation study of AMG 340 in metastatic castration-resistant prostate cancer. The company had acquired the drug via its acquisition of Teneobio in 2021 for up to $2.5 billion.This marks the latest in several BiTE candidates Amgen has discontinued, including the BCMA-targeting molecule pavurutamab last year. The company continues to develop its DLL3-targeting BiTE drug tarlatamab, having recently reported that it produced an objective response rate (ORR) of 40% in patients with advanced stage small-cell lung cancer who had failed two or more prior lines of treatment.Meanwhile, Amgen is testing the weight-loss drug AMG 133, also known as maridebart cafraglutide. The multispecific molecule, which inhibits GIP and GLP-1 receptors, is being evaluated in a Phase II study in overweight or obese adults with or without type 2 diabetes, with top-line results due in "late 2024."What analysts said:Analysts are looking ahead to the company's efforts in obesity. "Management…noted that they have a suite of preclinical obesity assets that they plan to bring forward 'over the next few years,'" remarked Salim Syed of Mizuho Securities.

Exactly a year after resuming dosing on a bispecific that hits BCMA, Amgen is scrapping the drug altogether for “strategic reasons.” The move — along with a separate decision to deprioritize acapatamab in favor of another PSMA-targeting drug, AMG 340, for the treatment of metastatic castrate-resistant prostate cancer — marks another round of trial and error as Amgen figures out the best configurations and uses of its half-life extended bispecific T cell engagers (BiTEs). The company made an unceremonial note about the BCMA exit as part of its Q2 pipeline update, noting that the drug has been discontinued. Known as AMG 701, it was being tested for multiple myeloma. Amgen had previously paused enrollment in a Phase I study for pavurutamab to discuss “protocol modifications to optimize safety monitoring and mitigation with the FDA.” It resumed dosing last year. It also appears to take the last BCMA project out of the pipeline. Researchers billed pavurutamab as a successor to AMG 420, which was one of the first BCMA bispecifics to enter the clinic but triggered high rates of infection in trials. And even before the halt, analysts weren’t particularly impressed by the early data from pavurutamab. Blincyto, the acute lymphoblastic leukemia therapy, remains the only FDA-approved BiTE. There’s still tarlatamab, which targets delta-like ligand 3 (DLL3) with a big focus on small cell lung cancer. And apart from PSMA, Amgen is also exploring whether going after STEAP1 — six-transmembrane epithelial antigen of the prostate 1 — can treat prostate cancer, through a Phase I trial of AMG 509.