On May 1, 2025 Amgen (NASDAQ:AMGN) reported financial results for the first quarter of 2025 (Press release, Amgen, MAY 1, 2025, View Source [SID1234652422]).
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"Demand for our products was strong globally in the first quarter. Ongoing new product launches and successful Phase 3 trial results for several products make us feel confident in our long-term growth prospects," said Robert A. Bradway, chairman and chief executive officer.
Key results include:
For the first quarter, total revenues increased 9% to $8.1 billion in comparison to the first quarter of 2024.
Product sales grew 11%, primarily driven by 14% volume growth, partially offset by 6% lower net selling price. U.S. sales grew 14%.
Fourteen products delivered at least double-digit sales growth in the first quarter, including Repatha (evolocumab), BLINCYTO (blinatumomab), TEZSPIRE (tezepelumab-ekko), EVENITY (romosozumab-aqqg), TAVNEOS (avacopan) and UPLIZNA (inebilizumab-cdon).
Our launch of IMDELLTRA (tarlatamab-dlle) generated $81 million of sales in the quarter and the Phase 3 confirmatory study demonstrated improved overall survival compared to chemotherapy. IMDELLTRA launched in Japan in April 2025.
GAAP earnings per share (EPS) were $3.20 for the first quarter of 2025 compared with a GAAP loss per share of $0.21 for the first quarter of 2024, resulting from an unrealized gain on our BeiGene, Ltd. equity investment during the first quarter of 2025 compared to an unrealized loss during the prior year period, partially offset by an Otezla intangible asset impairment charge of $800 million recorded during the first quarter of 2025.
GAAP operating income increased from $1.0 billion to $1.2 billion, and GAAP operating margin increased 1.1 percentage points to 15.0%.
Non-GAAP EPS increased 24% from $3.96 to $4.90, driven by higher revenues, partially offset by higher operating expenses.
Non-GAAP operating income increased from $3.1 billion to $3.6 billion and non-GAAP operating margin increased 2.5 percentage points to 45.7%.
The Company generated $1.0 billion of free cash flow in the first quarter of 2025 versus $0.5 billion in the first quarter of 2024. This increase reflects an $800 million tax deposit made in the first quarter of 2024 and current quarter business performance, partially offset by timing of working capital items and higher capital expenditures.
References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis," and "free cash flow" (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented in the attached reconciliations. Refer to Non-GAAP Financial Measures below for further discussion.
Product Sales Performance
General Medicine
Repatha (evolocumab) sales increased 27% year-over-year to $656 million in the first quarter, primarily driven by 41% volume growth, partially offset by 9% lower net selling price.
EVENITY (romosozumab-aqqg) sales increased 29% year-over-year to $442 million in the first quarter, driven by volume growth.
Prolia (denosumab) sales increased 10% year-over-year to $1.1 billion in the first quarter, primarily driven by 13% volume growth, partially offset by 5% lower net selling price. For 2025, we expect sales erosion driven by biosimilar competition, particularly in the second half of the year.
Rare Disease
TEPEZZA (teprotumumab-trbw) sales decreased 10% year-over-year to $381 million in the first quarter, primarily driven by 9% lower volume and 8% from a decrease in inventory levels, partially offset by higher net selling price.
KRYSTEXXA (pegloticase) sales were flat year-over-year at $236 million in the first quarter, as 11% volume growth was offset by 10% from a decrease in inventory levels.
UPLIZNA (inebilizumab-cdon) sales increased 14% year-over-year to $91 million in the first quarter, primarily driven by volume growth.
TAVNEOS (avacopan) sales increased 76% year-over-year to $90 million in the first quarter, primarily driven by volume growth.
Ultra-Rare products, which consist of RAVICTI (glycerol phenylbutyrate), PROCYSBI (cysteamine bitartrate), ACTIMMUNE (interferon gamma-1b), BUPHENYL (sodium phenylbutyrate) and QUINSAIR (levofloxacin), generated $179 million of sales in the first quarter. Sales increased 6% year-over-year for the first quarter, driven by volume growth.
Inflammation
TEZSPIRE (tezepelumab-ekko) sales increased 65% year-over-year to $285 million in the first quarter, driven by volume growth.
Otezla (apremilast) sales increased 11% year-over-year to $437 million in the first quarter, driven by 12% favorable changes to estimated sales deductions, as volume growth of 4% was offset by 5% lower net selling price.
Enbrel (etanercept) sales decreased 10% year-over-year to $510 million in the first quarter, driven by 47% lower net selling price resulting from increased 340B Program mix and higher commercial discounts, partially offset by 19% favorable changes to estimated sales deductions, higher inventory levels and volume growth. The year-over-year impact on net selling price is expected to be less pronounced in future quarters.
AMJEVITA (adalimumab-atto)/AMGEVITA (adalimumab) sales decreased 19% year-over-year to $136 million in the first quarter, primarily driven by 33% lower net selling price, partially offset by 11% volume growth.
WEZLANA (ustekinumab-auub)/WEZENLA (ustekinumab) generated $150 million of sales in the first quarter. WEZLANA launched in the U.S. in the first quarter of 2025 and is the first FDA-approved biosimilar for the treatment of adult and pediatric plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.
PAVBLU (aflibercept-ayyh) generated $99 million of sales in the first quarter. PAVBLU launched in the U.S. in the fourth quarter of 2024 and is the first available aflibercept biosimilar for the treatment of retinal conditions, including neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy.
Oncology
BLINCYTO (blinatumomab) sales increased 52% year-over-year to $370 million in the first quarter, primarily driven by volume growth.
Vectibix (panitumumab) sales increased 8% year-over-year to $267 million in the first quarter, driven by volume growth.
KYPROLIS (carfilzomib) sales decreased 14% year-over-year to $324 million in the first quarter, driven by lower volumes due to increased competition.
LUMAKRAS/LUMYKRAS (sotorasib) sales increased 4% year-over-year to $85 million in the first quarter, driven by volume growth, partially offset by lower net selling price.
XGEVA (denosumab) sales increased 1% year-over-year to $566 million in the first quarter. For 2025, we expect sales erosion driven by biosimilar competition, particularly in the second half of the year.
Nplate (romiplostim) sales decreased 1% year-over-year to $313 million in the first quarter as volume growth was more than offset by unfavorable changes to estimated sales deductions and foreign exchange impact.
IMDELLTRA (tarlatamab-dlle)/IMDYLLTRA (tarlatamab) generated $81 million of sales in the first quarter. Sales increased 21% quarter-over-quarter driven by volume growth.
MVASI (bevacizumab-awwb) sales decreased 11% year-over-year to $179 million in the first quarter, primarily driven by lower volume. Going forward, we expect continued sales erosion driven by competition.
Established Products
Our established products, which consist of Aranesp (darbepoetin alfa), Parsabiv (etelcalcetide) and Neulasta (pegfilgrastim), generated $557 million of sales in the first quarter. Sales decreased 3% year-over-year for the first quarter, driven by 10% lower net selling price and 3% unfavorable foreign exchange impact, partially offset by favorable changes to estimated sales deductions.
Product Sales Detail by Product and Geographic Region
$Millions, except percentages
Q1 ’25
Q1 ’24
YOY Δ
U.S
ROW
TOTAL
TOTAL
TOTAL
Repatha
$ 343
$ 313
$ 656
$ 517
27 %
EVENITY
320
122
442
342
29 %
Prolia
720
379
1,099
999
10 %
TEPEZZA
365
16
381
424
(10 %)
KRYSTEXXA
236
—
236
235
0 %
UPLIZNA
82
9
91
80
14 %
TAVNEOS
77
13
90
51
76 %
Ultra-Rare products(1)
171
8
179
169
6 %
TEZSPIRE
285
—
285
173
65 %
Otezla
343
94
437
394
11 %
Enbrel
504
6
510
567
(10 %)
AMJEVITA/AMGEVITA
4
132
136
168
(19 %)
WEZLANA/WEZENLA
123
27
150
1
*
PAVBLU
99
—
99
—
N/A
BLINCYTO
273
97
370
244
52 %
Vectibix
135
132
267
247
8 %
KYPROLIS
216
108
324
376
(14 %)
LUMAKRAS/LUMYKRAS
55
30
85
82
4 %
XGEVA
360
206
566
561
1 %
Nplate
201
112
313
317
(1 %)
IMDELLTRA/IMDYLLTRA
79
2
81
—
N/A
MVASI
138
41
179
202
(11 %)
Aranesp
91
249
340
349
(3 %)
Parsabiv
50
38
88
105
(16 %)
Neulasta
109
20
129
118
9 %
Other products(2)
283
57
340
397
(14 %)
Total product sales
$ 5,662
$ 2,211
$ 7,873
$ 7,118
11 %
* Change in excess of 100%
N/A = not applicable
(1) Ultra-Rare products consist of RAVICTI, PROCYSBI, ACTIMMUNE, BUPHENYL and QUINSAIR.
(2) Consists of Aimovig, AVSOLA, KANJINTI, RIABNI, EPOGEN, BEKEMV, NEUPOGEN, IMLYGIC, Corlanor, RAYOS, Sensipar/Mimpara, DUEXIS and PENNSAID, where Biosimilars total $171 million in Q1 ’25 and $175 million in Q1 ’24.
Operating Expense, Operating Margin and Tax Rate Analysis
On a GAAP basis:
Total Operating Expenses increased 8% year-over-year for the first quarter. Cost of Sales as a percentage of product sales decreased 7.3 percentage points driven by lower amortization expense from the fair value step-up of inventory acquired from Horizon and lower manufacturing costs, partially offset by changes in our sales mix. Research & Development (R&D) expenses increased 11% driven by higher spend in later-stage clinical programs, partially offset by lower spend in marketed product support and research and early pipeline. Selling, General & Administrative (SG&A) expenses decreased 7% driven by lower commercial product-related expenses and lower Horizon acquisition-related expenses, partially offset by higher general and administrative expenses. Other operating expenses consisted primarily of the Otezla intangible asset impairment charge of $800 million.
Operating Margin as a percentage of product sales increased 1.1 percentage points in the first quarter to 15.0%.
Tax Rate increased 78.5 percentage points in the first quarter due to the change in earnings mix as a result of the first quarter 2025 unrealized gains compared to the first quarter 2024 unrealized losses on our equity investments, primarily BeiGene.
On a non-GAAP basis:
Total Operating Expenses increased 4% year-over-year for the first quarter. Cost of Sales as a percentage of product sales decreased 0.8 percentage points driven by lower manufacturing costs, partially offset by changes in our sales mix. R&D expenses increased 12% driven by higher spend in later-stage clinical programs, partially offset by lower spend in marketed product support and research and early pipeline. SG&A expenses decreased 3% driven by lower commercial product-related expenses, partially offset by higher general and administrative expenses.
Operating Margin as a percentage of product sales increased 2.5 percentage points in the first quarter to 45.7%.
Tax Rate decreased 0.8 percentage points in the first quarter due to the change in earnings mix and net favorable items as compared to the prior year.
$Millions, except percentages
GAAP
Non-GAAP
Q1 ’25
Q1 ’24
YOY Δ
Q1 ’25
Q1 ’24
YOY Δ
Cost of Sales
$ 2,968
$ 3,200
(7 %)
$ 1,420
$ 1,340
6 %
% of product sales
37.7 %
45.0 %
(7.3) pts
18.0 %
18.8 %
(0.8) pts
Research & Development
$ 1,486
$ 1,343
11 %
$ 1,475
$ 1,317
12 %
% of product sales
18.9 %
18.9 %
— pts
18.7 %
18.5 %
0.2 pts
Selling, General & Administrative
$ 1,687
$ 1,808
(7 %)
$ 1,655
$ 1,712
(3 %)
% of product sales
21.4 %
25.4 %
(4.0) pts
21.0 %
24.1 %
(3.1) pts
Other
$ 830
$ 105
*
$ —
$ —
N/A
Total Operating Expenses
$ 6,971
$ 6,456
8 %
$ 4,550
$ 4,369
4 %
Operating Margin
Operating income as % of product sales
15.0 %
13.9 %
1.1 pts
45.7 %
43.2 %
2.5 pts
Tax Rate
12.3 %
(66.2) %
78.5 pts
14.6 %
15.4 %
(0.8) pts
pts: percentage points
* = Change in excess of 100%
N/A = not applicable
Cash Flow and Balance Sheet
The Company generated $1.0 billion of free cash flow in the first quarter of 2025 versus $0.5 billion in the first quarter of 2024. This increase reflects an $800 million tax deposit made in the first quarter of 2024 and current quarter business performance, partially offset by timing of working capital items and higher capital expenditures.
The Company declared a first quarter 2025 dividend on December 10, 2024 of $2.38 that was paid on March 7, 2025 to all stockholders of record as of February 14, 2025, representing a 6% increase from the same period in 2024.
During the first quarter of 2025, the Company reduced principal debt outstanding by $2.8 billion.
During the first quarter, there were no repurchases of shares of common stock.
Cash and cash equivalents totaled $8.8 billion and debt outstanding totaled $57.4 billion as of March 31, 2025.
$Billions, except shares
Q1 ’25
Q1 ’24
YOY Δ
Operating Cash Flow
$ 1.4
$ 0.7
$ 0.7
Capital Expenditures
$ 0.4
$ 0.2
$ 0.2
Free Cash Flow
$ 1.0
$ 0.5
$ 0.5
Dividends Paid
$ 1.3
$ 1.2
$ 0.1
Share Repurchases
$ —
$ —
$ —
Average Diluted Shares (millions)
541
536
5
Note: Numbers may not add due to rounding
$Billions
3/31/25
12/31/24
YTD Δ
Cash and Cash Equivalents
$ 8.8
$ 12.0
$ (3.2)
Debt Outstanding
$ 57.4
$ 60.1
$ (2.7)
Note: Numbers may not add due to rounding
2025 Guidance
For the full year 2025, the Company expects:
Total revenues in the range of $34.3 billion to $35.7 billion.
On a GAAP basis, EPS in the range of $12.21 to $13.46, and a tax rate in the range of 11.0% to 12.5%.
On a non-GAAP basis, EPS in the range of $20.00 to $21.20, and a tax rate in the range of 14.5% to 16.0%.
Capital expenditures to be approximately $2.3 billion.
Share repurchases not to exceed $500 million.
This guidance includes the estimated impact of implemented tariffs, but does not account for any tariffs that could be implemented in the future, including potential sector-specific tariffs.
First Quarter Product and Pipeline Update
The Company provided the following updates on selected product and pipeline programs:
General Medicine
MariTide (maridebart cafraglutide, AMG 133)
MariTide is a differentiated peptide-antibody conjugate that activates the glucagon like peptide 1 (GLP-1) receptor and antagonizes the gastric inhibitory polypeptide receptor (GIPR).
MARITIME-1, a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of maridebart cafraglutide is enrolling adults living with overweight or obesity, without Type 2 diabetes mellitus.
MARITIME-2, a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of maridebart cafraglutide is enrolling adults living with overweight or obesity, with Type 2 diabetes mellitus.
Planning for additional MARITIME Phase 3 studies across multiple indications remains on track, with additional studies expected to initiate throughout 2025.
Part 2 of the Phase 2 chronic weight management study is ongoing in adults living with overweight or obesity, with or without Type 2 diabetes mellitus. Data readout is anticipated in H2 2025.
A Phase 2 study investigating MariTide for the treatment of Type 2 diabetes mellitus has completed enrollment of adults living with and without obesity. Data readout is anticipated in H2 2025.
AMG 513
A Phase 1 study of AMG 513 is enrolling people living with obesity following removal of the clinical hold by the U.S. Food and Drug Administration (FDA).
Repatha
VESALIUS-CV, a Phase 3 CV outcomes study of Repatha, is ongoing in patients at high CV risk without prior myocardial infarction or stroke. Data readout is event driven and anticipated in H2 2025.
EVOLVE-MI, a Phase 4 study of Repatha administered within 10 days of an acute myocardial infarction to reduce the risk of CV events, is ongoing.
Olpasiran (AMG 890)
Olpasiran is a potentially best-in-class small interfering ribonucleic acid (siRNA) molecule that reduces lipoprotein(a) (Lp(a)) synthesis in the liver.
The OCEAN(a)-outcomes trial, a Phase 3 secondary prevention cardiovascular (CV) outcomes study, is ongoing in patients with atherosclerotic CV disease and elevated Lp(a).
A Phase 3 CV outcomes study in patients with elevated Lp(a) and at high risk for a first CV event is expected to be initiated in H2 2025/H1 2026.
Rare Disease
TAVNEOS
A Phase 3, open-label study of TAVNEOS in combination with rituximab or a cyclophosphamide-containing regimen, is enrolling patients from 6 years to < 18 years of age with active ANCA-associated vasculitis (Granulomatosis with Polyangiitis (GPA)/Microscopic Polyangiitis (MPA)).
TEPEZZA
Regulatory review is underway in multiple additional geographies, including with the European Medicines Agency (EMA), where approval is anticipated in H2 2025.
A Phase 3 study of TEPEZZA in Japan is enrolling patients with chronic/low clinical activity score thyroid eye disease (TED).
A Phase 3 study evaluating the subcutaneous route of administration of teprotumumab is enrolling patients with TED.
UPLIZNA
In April, the FDA approved UPLIZNA for the treatment of Immunoglobulin G4-Related Disease (IgG4-RD) in adult patients.
In April, data from the UPLIZNA Phase 3 MINT study in patients with generalized myasthenia gravis (gMG) were presented and simultaneously published in the New England Journal of Medicine. These data demonstrated durable and sustained efficacy of UPLIZNA treatment compared to placebo (adjusted difference, -1.8 at week 26; −2.8 at week 52) as measured by the change in baseline of Myasthenia Gravis Activities of Daily Living (MG-ADL) score in the acetylcholine receptor autoantibody-positive (AChR+) subpopulation through week 52. Among the AChR+ patients in the UPLIZNA group, 72% had a ≥3 point improvement in the MG-ADL score, compared to 45% in placebo at week 52. No new safety signals were identified.
The FDA has accepted the regulatory submission of the MINT Phase 3 data with a PDUFA date of December 14, 2025.
Dazodalibep
Dazodalibep is a fusion protein that inhibits CD40L.
Two Phase 3 studies of dazodalibep in Sjögren’s disease are enrolling patients. The first study is in patients with moderate-to-severe systemic disease activity, and the second study is in patients with moderate-to-severe symptomatic burden and low systemic disease activity.
Daxdilimab
Daxdilimab is a fully human monoclonal antibody targeting immunoglobulin-like transcript 7 (ILT7).
A Phase 2 study of daxdilimab is ongoing in patients with moderate-to-severe active primary discoid lupus erythematosus refractory to standard of care.
A Phase 2 study of daxdilimab is ongoing in patients with dermatomyositis and antisynthetase inflammatory myositis.
Inflammation
TEZSPIRE
Two Phase 3 studies of TEZSPIRE were initiated and are enrolling adults with moderate to very severe chronic obstructive pulmonary disease (COPD) and a BEC ≥ 150 cells/µl.
In March, data from the Phase 3 WAYPOINT study of TEZSPIRE in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) were presented and simultaneously published in the New England Journal of Medicine demonstrating that treatment with TEZSPIRE:
significantly reduced Nasal Polyp Score (NPS) by -2.065 at week 52.
significantly reduced nasal congestion (measured by participant-reported Nasal Congestion Score [NCS]) by -1.028 at week 52.
Improvements in NPS were observed as early as week four, and NCS as early as week two, and were sustained through week 52.
significantly reduced the need for nasal polyp surgery by 98%.
significantly reduced the need for systemic corticosteroid treatment by 88%.
had a safety profile consistent with its approved severe asthma indication.
The FDA has accepted the regulatory submission of the WAYPOINT Phase 3 data with a PDUFA date of October 19, 2025.
A Phase 3 study of TEZSPIRE is enrolling patients with eosinophilic esophagitis.
Rocatinlimab (AMG 451/KHK4083)
Rocatinlimab is a first-in-class T-cell rebalancing monoclonal antibody that inhibits and reduces OX40-positive pathogenic T-cells.
The eight study ROCKET Phase 3 program evaluating rocatinlimab in patients with moderate-to-severe atopic dermatitis (AD) has enrolled over 3,300 patients. Enrollment is now complete in seven studies.
In March, detailed data were presented from the ROCKET HORIZON Phase 3 study, which met its co-primary and all key secondary endpoints.
In March, data were announced from three additional ROCKET program Phase 3 studies:
The IGNITE study, which evaluated two dose strengths of rocatinlimab, met its co-primary endpoints and all key secondary endpoints at week 24:
42.3% of patients in the higher dose group achieved ≥75% reduction from baseline in Eczema Area and Severity Index score (EASI-75), a 29.5% difference vs. placebo. In the lower dose group, 36.3% of patients achieved EASI-75, a 23.4% difference vs. placebo.
23.6% of patients in the higher dose group achieved a validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear) with a ≥2-point reduction from baseline (vIGA-AD 0/1), a 14.9% difference vs. placebo. In the lower dose group, 19.1% of patients achieved this endpoint, a 10.3% difference vs. placebo.
22.7% of patients in the higher dose group achieved a revised Investigator’s Global Assessment (rIGA) score of 0/1 with a ≥2-point reduction from baseline (a more stringent measure of efficacy than vIGA-AD 0/1), a 14.4% difference vs. placebo. In the lower dose group, 16.3% of patients achieved this endpoint, an 8.0% difference vs. placebo.
The SHUTTLE study, which evaluated two dose strengths of rocatinlimab in combination with topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI), met its co-primary endpoints and all key secondary endpoints at week 24.
The VOYAGER study, which successfully demonstrated that rocatinlimab does not interfere with responses to tetanus and meningococcal vaccinations.
Across ROCKET program results to date, safety findings were generally consistent with the previously observed safety profile of rocatinlimab. The most frequent treatment-emergent adverse events (≥5%) with higher observed proportion in rocatinlimab groups were pyrexia, chills and headache. A higher number of patients receiving rocatinlimab vs. placebo experienced gastrointestinal ulceration events, with an overall incidence of less than 1%.
Key upcoming milestones from the ROCKET Phase 3 program:
ROCKET ASCEND is a study evaluating rocatinlimab maintenance therapy in adult and adolescent patients with moderate-to-severe AD. Data readout is anticipated in H2 2025.
ROCKET ASTRO is a 52-week study evaluating rocatinlimab in adolescent patients with moderate-to-severe AD. Data readout is anticipated in H2 2025.
A Phase 2 study of rocatinlimab is enrolling patients with moderate-to-severe asthma.
A Phase 3 study of rocatinlimab is enrolling patients with prurigo nodularis (PN).
Blinatumomab
Blinatumomab is a bispecific T-cell engager (BiTE) molecule targeting CD19.
A Phase 2 study of blinatumomab in autoimmune disease was initiated in adults with systemic lupus erythematosus (SLE).
Inebilizumab
Inebilizumab is a B-cell depleting monoclonal antibody targeting CD19.
A Phase 2 study of inebilizumab in autoimmune disease was initiated in adults with SLE.
AMG 104 (AZD8630)
AMG 104 is an inhaled anti-thymic stromal lymphopoietin (TSLP) fragment antigen-binding (Fab).
A Phase 2 study is enrolling patients with asthma.
Oncology
BLINCYTO / blinatumomab
In April, the FDA granted Breakthrough Therapy Designation for subcutaneous blinatumomab in the treatment of adults with relapsed/refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL).
A Phase 1/2 study of subcutaneous blinatumomab is ongoing in the dose-expansion and optimization phase in adult patients with relapsed or refractory Philadelphia chromosome (Ph)-negative B-ALL. The Company is planning to advance blinatumomab subcutaneous administration to a potentially registration-enabling Phase 2 portion of this study with initiation in H2 2025.
Golden Gate, a Phase 3 study of BLINCYTO alternating with low-intensity chemotherapy, is enrolling older adult patients with newly diagnosed Ph-negative B-ALL.
IMDELLTRA / tarlatamab
IMDELLTRA is the first and only FDA-approved delta-like ligand 3 (DLL3) targeting BiTE molecule.
In April, the Company announced that the global Phase 3 DeLLphi-304 study met its primary endpoint of improved overall survival at a planned interim analysis. This study evaluated IMDELLTRA compared to local standard-of-care chemotherapy as a treatment for patients with small cell lung cancer (SCLC) who progressed on or after a single line of platinum-based chemotherapy. The safety profile for IMDELLTRA was consistent with its known profile. Together these randomized data have the potential to establish IMDELLTRA as a new standard of care in second-line SCLC. Detailed data from DeLLphi-304 will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting (ASCO) (Free ASCO Whitepaper) in June.
The Company is advancing a comprehensive, global clinical development program across extensive-stage and limited-stage SCLC:
DeLLphi-303, a Phase 1b study of IMDELLTRA in combination with a programmed cell death protein ligand-1 (PD-L1) inhibitor, carboplatin and etoposide or separately in combination with PD-L1 alone, is ongoing in patients with first-line ES-SCLC.
DeLLphi-305, a Phase 3 study of IMDELLTRA and durvalumab, is enrolling patients with first-line ES-SCLC in the maintenance setting.
DeLLphi-306, a Phase 3 study of IMDELLTRA following concurrent chemoradiation therapy, is enrolling patients with limited-stage SCLC.
DeLLphi-308, a Phase 1b study evaluating subcutaneous tarlatamab, is enrolling patients with second line or later ES-SCLC.
DeLLphi-309, a Phase 2 study evaluating alternative intravenous dosing regimens in second-line ES-SCLC, is enrolling patients.
DeLLphi-310, a Phase 1b study, was initiated in patients with ES-SCLC evaluating IMDELLTRA in combination with YL201, a B7-H3 targeting antibody-drug conjugate, with or without anti-PD-L1.
DeLLphi-312, a Phase 3 study of first-line IMDELLTRA with carboplatin, etoposide and durvalumab is planned to initiate in patients with ES-SCLC by mid-2025.
Xaluritamig (AMG 509)
Xaluritamig is a first-in-class BiTE targeting six-transmembrane epithelial antigen of prostate 1 (STEAP1).
A Phase 3 study of xaluritamig is enrolling patients with metastatic castrate resistant prostate cancer (mCRPC) who have previously been treated with taxane-based chemotherapy.
A Phase 1 study of xaluritamig monotherapy has completed enrollment of patients with mCRPC who have not yet received taxane-based chemotherapy and has also completed enrollment of patients with mCPRC who have previously received taxane-based chemotherapy in a fully outpatient treatment setting to further improve administration convenience. This study continues to enroll mCRPC patients into a combination treatment of xaluritamig and abiraterone.
A Phase 1b study evaluating neoadjuvant xaluritamig therapy prior to radical prostatectomy is enrolling patients with newly diagnosed localized intermediate or high–risk prostate cancer.
A Phase 1b study of xaluritamig is enrolling patients with high-risk biochemically recurrent prostate cancer after definitive therapy.
AMG 193
AMG 193 is a first-in-class small molecule methylthioadenosine (MTA)-cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor.
A Phase 2 study evaluating the efficacy, safety, tolerability and pharmacokinetics of AMG 193 is enrolling patients with methylthioadenosine phosphorylase (MTAP)-null previously treated advanced non-small cell lung cancer (NSCLC).
A Phase 1/1b/2 study of AMG 193 is enrolling patients with advanced MTAP-null solid tumors in the dose-expansion portion of the study.
A Phase 1b study of AMG 193 alone or in combination with other therapies is enrolling patients with advanced MTAP-null thoracic malignancies.
A Phase 1b study of AMG 193 in combination with other therapies is enrolling patients with advanced MTAP-null gastrointestinal, biliary tract and pancreatic cancers.
A Phase 1/2 study of AMG 193 in combination with IDE397, an investigational methionine adenosyltransferase 2A (MAT2A) inhibitor, will be discontinued following a wind-down period.
Bemarituzumab
Bemarituzumab is a first-in-class fibroblast growth factor receptor 2b (FGFR2b) targeting monoclonal antibody.
FORTITUDE-101, a Phase 3 study of bemarituzumab plus chemotherapy, is ongoing in patients with first-line gastric cancer. Data readout is anticipated in Q2 2025.
FORTITUDE-102, a Phase 1b/3 study of bemarituzumab plus chemotherapy and nivolumab, is ongoing in patients with first-line gastric cancer. Phase 3 data readout is anticipated in H2 2025.
FORTITUDE-103, a Phase 1b/2 study of bemarituzumab plus oral chemotherapy regimens with or without nivolumab, is enrolling patients with first-line gastric cancer.
FORTITUDE-301, a Phase 1b/2 basket study of bemarituzumab monotherapy, is ongoing in patients with solid tumors with FGFR2b overexpression.
LUMAKRAS/LUMYKRAS
CodeBreaK 301, a Phase 3 study of LUMAKRAS in combination with Vectibix and FOLFIRI, is enrolling patients with first-line KRAS G12C–mutated CRC.
CodeBreaK 202 (CB202), a Phase 3 study of LUMAKRAS plus chemotherapy vs. pembrolizumab plus chemotherapy, is enrolling patients with first-line KRAS G12C–mutated and PD-L1 negative advanced NSCLC.
Nplate
The final analysis of a Phase 3 study of Nplate as supportive care in chemotherapy-induced thrombocytopenia in gastrointestinal malignancies is complete. Data from this study will be presented at ASCO (Free ASCO Whitepaper) in June.
Biosimilars
A randomized, double-blind pharmacokinetic similarity study of ABP 206 compared with OPDIVO (nivolumab) has completed enrollment of patients with resected stage III or stage IV melanoma in the adjuvant setting. Data readout is anticipated in H2 2025.
A randomized, double-blind comparative clinical study of ABP 206 compared with OPDIVO is enrolling patients with treatment-naïve unresectable or metastatic melanoma.
A randomized, double-blind pharmacokinetic similarity study of ABP 234 compared with KEYTRUDA (pembrolizumab) is enrolling patients with early-stage non-squamous non-small cell lung cancer as adjuvant treatment.
A randomized, double-blind combined pharmacokinetic/comparative clinical study of ABP 234 compared to KEYTRUDA is enrolling patients with advanced or metastatic non-squamous non-small cell lung cancer.
A randomized, double-blind pharmacokinetic similarity/comparative clinical study of ABP 692 compared to OCREVUS (ocrelizumab) was initiated and is currently enrolling patients with relapsing-remitting multiple sclerosis.
TEZSPIRE is being developed in collaboration with AstraZeneca.
AMG 104 is being developed in collaboration with AstraZeneca.
Rocatinlimab, formerly AMG 451/KHK4083, is being developed in collaboration with Kyowa Kirin.
Xaluritamig, formerly AMG 509, is being developed pursuant to a research collaboration with Xencor, Inc.
IDE397 is an investigational MAT2A inhibitor from IDEAYA Biosciences.
YL201 is an investigational B7-H3 targeting antibody-drug conjugate being developed by MediLink.
OPDIVO is a registered trademark of Bristol-Myers Squibb Company.
KEYTRUDA is a registered trademark of Merck & Co., Inc.
OCREVUS is a registered trademark of Genentech, Inc.