On August 5, 2025 Amgen (NASDAQ:AMGN) reported financial results for the second quarter of 2025 (Press release, Amgen, AUG 5, 2025, View Source [SID1234654776]).
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"We’re delivering strong performance and reaching more patients with innovative medicines and biosimilars that address serious diseases. We continue to invest in science that enables longer, healthier lives and supports sustainable, long-term growth," said Robert A. Bradway, chairman and chief executive officer.
Key results include:
For the second quarter, total revenues increased 9% to $9.2 billion in comparison to the second quarter of 2024.
Product sales grew 9%, driven by 13% volume growth, partially offset by 3% lower net selling price.
Fifteen products delivered at least double-digit sales growth in the second quarter, including Repatha (evolocumab), EVENITY (romosozumab-aqqg), IMDELLTRA (tarlatamab-dlle)/IMDYLLTRA (tarlatamab), BLINCYTO (blinatumomab), TEZSPIRE (tezepelumab-ekko), UPLIZNA (inebilizumab-cdon) and TAVNEOS (avacopan).
GAAP earnings per share (EPS) increased 92% from $1.38 to $2.65, primarily driven by higher revenues.
GAAP operating income increased from $1.9 billion to $2.7 billion, and GAAP operating margin increased 6.6 percentage points to 30.3%.
Non-GAAP EPS increased 21% from $4.97 to $6.02, primarily driven by higher revenues, partially offset by higher operating expenses.
Non-GAAP operating income increased from $3.9 billion to $4.3 billion, and non-GAAP operating margin increased 0.7 percentage points to 48.9%.
The Company generated $1.9 billion of free cash flow in the second quarter of 2025 versus $2.2 billion in the second quarter of 2024, driven by 2024 tax payments deferred to 2025 and higher capital expenditures, partially offset by business performance.
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 31% year-over-year to $696 million in the second quarter, driven by 36% volume growth, partially offset by unfavorable changes to estimated sales deductions.
EVENITY (romosozumab-aqqg) sales increased 32% year-over-year to $518 million in the second quarter, primarily driven by volume growth.
Prolia (denosumab) sales decreased 4% year-over-year to $1.1 billion in the second quarter, driven by lower net selling price. For 2025, we expect sales erosion driven by biosimilar competition in the second half of the year, as biosimilars have now launched in the U.S. market.
Rare Disease
TEPEZZA (teprotumumab-trbw) sales increased 5% year-over-year to $505 million in the second quarter, primarily driven by higher inventory levels.
KRYSTEXXA (pegloticase) sales increased 19% year-over-year to $349 million in the second quarter, of which 12% was derived from higher inventory levels and 6% from volume growth.
UPLIZNA (inebilizumab-cdon) sales increased 91% year-over-year to $176 million in the second quarter, driven by 79% volume growth, with 16% derived from higher inventory levels. Year-over-year sales benefited from the timing of shipments to our ex-U.S. partner that occurred in the third quarter of 2024. Excluding these shipments, sales grew by 56% year-over-year in the second quarter.
TAVNEOS (avacopan) sales increased 55% year-over-year to $110 million in the second quarter, driven by volume growth.
Ultra-Rare products, which consist of RAVICTI (glycerol phenylbutyrate), PROCYSBI (cysteamine bitartrate), ACTIMMUNE (interferon gamma-1b), QUINSAIR (levofloxacin) and BUPHENYL (sodium phenylbutyrate), generated $183 million of sales in the second quarter. Sales decreased 2% year-over-year for the second quarter, driven by lower net selling price.
Inflammation
TEZSPIRE (tezepelumab-ekko) sales increased 46% year-over-year to $342 million in the second quarter, driven by volume growth.
Otezla (apremilast) sales increased 14% year-over-year to $618 million in the second quarter, driven by 12% favorable changes to estimated sales deductions and 4% volume growth.
Enbrel (etanercept) sales decreased 34% year-over-year to $604 million in the second quarter, driven by 20% unfavorable changes to estimated sales deductions and 19% lower net selling price resulting from increased 340B Program mix and the impact of the U.S. Medicare Part D redesign, partially offset by 3% volume growth.
AMJEVITA (adalimumab-atto)/AMGEVITA (adalimumab) sales were flat year-over-year at $133 million in the second quarter.
PAVBLU (aflibercept-ayyh) generated $130 million of sales in the second quarter.
WEZLANA (ustekinumab-auub)/WEZENLA (ustekinumab) generated $35 million of sales in the second quarter.
Oncology
BLINCYTO (blinatumomab) sales increased 45% year-over-year to $384 million in the second quarter, driven by volume growth.
Vectibix (panitumumab) sales increased 13% year-over-year to $305 million in the second quarter, driven by volume growth.
KYPROLIS (carfilzomib) sales were flat year-over-year at $378 million in the second quarter.
LUMAKRAS/LUMYKRAS (sotorasib) sales increased 6% year-over-year to $90 million in the second quarter, driven by 16% volume growth, partially offset by 10% lower net selling price.
XGEVA (denosumab) sales decreased 5% year-over-year to $532 million in the second quarter, driven by 2% unfavorable changes to estimated sales deductions and volume decline. For 2025, we expect sales erosion driven by biosimilar competition in the second half of the year, as biosimilars have now launched in the U.S. market.
Nplate (romiplostim) sales increased 7% year-over-year to $369 million in the second quarter, driven by volume growth.
IMDELLTRA (tarlatamab-dlle)/IMDYLLTRA (tarlatamab) generated $134 million of sales in the second quarter. Sales increased 65% quarter-over-quarter, driven by volume growth.
MVASI (bevacizumab-awwb) sales increased 22% year-over-year to $191 million in the second quarter, driven by 16% favorable changes to estimated sales deductions, 6% volume growth and 5% higher net selling price, partially offset by lower inventory levels. In the quarter, MVASI benefited from competitor bevacizumab product shortages, and going forward, we expect to return to continued sales erosion driven by competition.
Established Products
Our established products, which consist of Aranesp (darbepoetin alfa), Parsabiv (etelcalcetide) and Neulasta (pegfilgrastim), generated $533 million of sales in the second quarter. Sales decreased 5% year-over-year for the second quarter, driven by 14% lower net selling price and 4% lower volume, partially offset by favorable changes to estimated sales deductions.
Product Sales Detail by Product and Geographic Region
$Millions, except percentages
Q2 ’25
Q2 ’24
YOY Δ
U.S
ROW
TOTAL
TOTAL
TOTAL
Repatha
$ 361
$ 335
$ 696
$ 532
31 %
EVENITY
395
123
518
391
32 %
Prolia
745
377
1,122
1,165
(4 %)
TEPEZZA
466
39
505
479
5 %
KRYSTEXXA
349
—
349
294
19 %
UPLIZNA
132
44
176
92
91 %
TAVNEOS
103
7
110
71
55 %
Ultra-Rare products(1)
175
8
183
187
(2 %)
TEZSPIRE
342
—
342
234
46 %
Otezla
512
106
618
544
14 %
Enbrel
597
7
604
909
(34 %)
AMJEVITA/AMGEVITA
—
133
133
133
— %
PAVBLU
126
4
130
—
N/A
WEZLANA/WEZENLA
—
35
35
—
N/A
BLINCYTO
270
114
384
264
45 %
Vectibix
144
161
305
270
13 %
KYPROLIS
232
146
378
377
0 %
LUMAKRAS/LUMYKRAS
52
38
90
85
6 %
XGEVA
347
185
532
562
(5 %)
Nplate
228
141
369
346
7 %
IMDELLTRA/IMDYLLTRA
107
27
134
12
*
MVASI
142
49
191
157
22 %
Aranesp
107
252
359
348
3 %
Parsabiv
51
41
92
106
(13 %)
Neulasta
63
19
82
105
(22 %)
Other products(2)
278
56
334
378
(12 %)
Total product sales
$ 6,324
$ 2,447
$ 8,771
$ 8,041
9 %
N/A = not applicable
* Change in excess of 100%
(1) Ultra-Rare products consist of RAVICTI, PROCYSBI, ACTIMMUNE, QUINSAIR and BUPHENYL
(2) Consists of Aimovig, KANJINTI, AVSOLA, EPOGEN, RIABNI, BKEMV/BEKEMV, IMLYGIC, NEUPOGEN, Corlanor, RAYOS, DUEXIS, PENNSAID and Sensipar/Mimpara, where Biosimilars total $172 million in Q2 ’25 and $183 million in Q2 ’24
Operating Expense, Operating Margin and Tax Rate Analysis
On a GAAP basis:
Total Operating Expenses increased 1% year-over-year for the second quarter. Cost of Sales as a percentage of product sales decreased 5.9 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 higher profit share expense and changes in our sales mix. Research & Development (R&D) expenses increased 21% driven by investments in later-stage clinical programs, including those related to MariTide, for which four Phase 3 studies are underway. Selling, General & Administrative (SG&A) expenses decreased 5% driven by lower commercial product-related expenses and lower Horizon acquisition-related expenses. Other operating expenses include litigation expenses.
Operating Margin as a percentage of product sales increased 6.6 percentage points in the second quarter to 30.3%.
Tax Rate increased 2.7 percentage points in the second quarter due to the change in earnings mix, including lower amortization expense from the fair value step-up of inventory acquired from Horizon and current year net unfavorable items, as compared to the prior year.
On a non-GAAP basis:
Total Operating Expenses increased 8% year-over-year for the second quarter. Cost of Sales as a percentage of product sales increased 0.2 percentage points driven by higher profit share expense and changes in our sales mix, partially offset by lower manufacturing costs. R&D expenses increased 18% driven by investments in later-stage clinical programs, including those related to MariTide, for which four Phase 3 studies are underway. SG&A expenses decreased 2% primarily driven by lower commercial product-related expenses.
Operating Margin as a percentage of product sales increased 0.7 percentage points in the second quarter to 48.9%.
Tax Rate decreased 0.7 percentage points in the second quarter due to the change in earnings mix.
$Millions, except percentages
GAAP
Non-GAAP
Q2 ’25
Q2 ’24
YOY Δ
Q2 ’25
Q2 ’24
YOY Δ
Cost of Sales
$ 3,011
$ 3,236
(7 %)
$ 1,551
$ 1,406
10 %
% of product sales
34.3 %
40.2 %
(5.9) pts
17.7 %
17.5 %
0.2 pts
Research & Development
$ 1,744
$ 1,447
21 %
$ 1,685
$ 1,423
18 %
% of product sales
19.9 %
18.0 %
1.9 pts
19.2 %
17.7 %
1.5 pts
Selling, General & Administrative
$ 1,691
$ 1,785
(5 %)
$ 1,650
$ 1,686
(2 %)
% of product sales
19.3 %
22.2 %
(2.9) pts
18.8 %
21.0 %
(2.2) pts
Other
$ 77
$ 11
*
$ —
$ —
N/A
Total Operating Expenses
$ 6,523
$ 6,479
1 %
$ 4,886
$ 4,515
8 %
Operating Margin
Operating income as % of product sales
30.3 %
23.7 %
6.6 pts
48.9 %
48.2 %
0.7 pts
Tax Rate
8.7 %
6.0 %
2.7 pts
14.2 %
14.9 %
(0.7) pts
pts: percentage points
* = Change in excess of 100%
N/A = not applicable
Cash Flow and Balance Sheet
The Company generated $1.9 billion of free cash flow in the second quarter of 2025 versus $2.2 billion in the second quarter of 2024, driven by timing of 2024 tax payments deferred to 2025 and higher capital expenditures, partially offset by business performance.
The Company declared a second quarter 2025 dividend on March 4, 2025 of $2.38 per share that was paid on June 6, 2025 to all stockholders of record as of May 16, 2025, representing a 6% increase from the same period in 2024.
The Company retired $1.4 billion of debt during the second quarter of 2025, and $4.3 billion year to date.
During the second quarter of 2025, there were no repurchases of shares of common stock.
Cash and cash equivalents totaled $8.0 billion and debt outstanding totaled $56.2 billion as of June 30, 2025.
$Billions, except shares
Q2 ’25
Q2 ’24
YOY Δ
Operating Cash Flow
$ 2.3
$ 2.5
$ (0.2)
Capital Expenditures
$ 0.4
$ 0.2
$ 0.1
Free Cash Flow
$ 1.9
$ 2.2
$ (0.3)
Dividends Paid
$ 1.3
$ 1.2
$ 0.1
Share Repurchases
$ 0.0
$ 0.0
$ 0.0
Average Diluted Shares (millions)
541
541
0
Note: Numbers may not add due to rounding
$Billions
6/30/25
12/31/24
YTD Δ
Cash and Cash Equivalents
$ 8.0
$ 12.0
$ (3.9)
Debt Outstanding
$ 56.2
$ 60.1
$ (3.9)
Note: Numbers may not add due to rounding
For the full year 2025, the Company expects:
Total revenues in the range of $35.0 billion to $36.0 billion.
On a GAAP basis, EPS in the range of $10.97 to $12.11, and a tax rate in the range of 11.0% to 12.5%.
On a non-GAAP basis, EPS in the range of $20.20 to $21.30, 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 or potential pricing actions announced or described but not implemented as well as any tariffs, sector specific tariffs, or pricing actions that could be implemented in the future.
Second 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 glucose-dependent insulinotropic polypeptide receptor (GIPR).
In June, the underlying details from Part 1 of the Phase 2 study of MariTide and complete results from the primary analysis of the Phase 1 pharmacokinetics low dose initiation (PK-LDI) study evaluating lower starting doses of MariTide were presented at the American Diabetes Association 85th Scientific Sessions and simultaneously published in the New England Journal of Medicine.
In the Phase 2 study per the efficacy estimand1, MariTide demonstrated:
up to ~20% average weight loss in people living with obesity without Type 2 diabetes (T2D).
up to ~17% average weight loss in people living with obesity with T2D.
no weight loss plateau by 52 weeks, indicating the potential for further weight reduction.
robust and sustained reduction in hemoglobin A1c (HbA1c) of up to 2.2% in people living with obesity and T2D.
improvements across pre-specified cardiometabolic measures, including waist circumference, blood pressure, high-sensitivity C-reactive protein (hs-CRP) and select lipid parameters.
No new safety signals were identified in the Phase 2 study and tolerability was consistent with the GLP-1 class. The most frequently reported adverse events (AEs) were gastrointestinal (GI) related, and most were mild to moderate, were predominantly limited to initial dosing and less frequent when dose escalation was used without compromising efficacy.
Discontinuation rates of MariTide due to GI AEs in the dose escalation arms (up to 7.8%) were lower than non-dose escalation arms.
The Phase 1 PK-LDI study showed participants that received 21 mg/70 mg/350 mg had an overall incidence of vomiting of 24.4% and participants that received 35 mg/70 mg/350 mg had an overall incidence of vomiting of 22.5%. There were no discontinuations due to GI AEs at any time during the study.
Part 2 of the Phase 2 chronic weight management study is ongoing in adults living with obesity or overweight, with or without T2D. Data readout is anticipated in Q4 2025.
A Phase 2 study investigating MariTide for the treatment of T2D is ongoing in adults living with and without obesity. Data readout is anticipated in Q4 2025.
MARITIME-1, a Phase 3 study of MariTide is enrolling adults living with obesity or overweight, without T2D.
MARITIME-2, a Phase 3 study of MariTide is enrolling adults living with obesity or overweight, with T2D.
MARITIME-CV, a Phase 3 study of MariTide on cardiovascular (CV) outcomes was initiated and is enrolling adults living with established atherosclerotic cardiovascular disease and obesity or overweight.
MARITIME-HF, a Phase 3 study of MariTide on reduction of heart failure events and cardiovascular risk, was initiated and is enrolling adults living with heart failure with preserved or mildly reduced ejection fraction and obesity.
The Company is planning to initiate Phase 3 study of obstructive sleep apnea in H2 2025.
AMG 513
A Phase 1 study of AMG 513 is enrolling adults living with obesity.
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 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
UPLIZNA
U.S. Food and Drug Administration (FDA) review of the MINT Phase 3 data in patients with generalized myasthenia gravis is ongoing, with a PDUFA date of December 14, 2025.
TEPEZZA
In June, the European Commission granted marketing authorization approval of TEPEZZA for the treatment of adults with moderate to severe thyroid eye disease (TED). Regulatory review is underway in multiple additional geographies.
A Phase 3 study of TEPEZZA in Japan is enrolling patients with chronic/low clinical activity score TED.
A Phase 3 study evaluating the subcutaneous route of administration of teprotumumab has completed enrollment of patients with TED.
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)).
Dazodalibep
Dazodalibep is a fusion protein that inhibits CD40L.
Two Phase 3 studies of dazodalibep in Sjögren’s disease are underway. The first study has completed enrollment of patients with moderate-to-severe systemic disease activity. The second study is enrolling 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.
AMG 329
AMG 329 is a fully human monoclonal antibody targeting FMS-like tyrosine kinase 3 (FLT3) ligand.
A Phase 2 study of AMG 329 is ongoing in patients with Sjögren’s disease.
AMG 732
AMG 732 is an insulin-like growth factor-1 receptor (IGF-1R) targeting monoclonal antibody.
A Phase 2 study of AMG 732 is enrolling patients with moderate-to-severe active TED.
Inflammation
TEZSPIRE
Two Phase 3 studies of TEZSPIRE are enrolling adults with moderate to very severe chronic obstructive pulmonary disease (COPD) and a BEC ≥ 150 cells/µl.
In May, primary results from the Phase 3b WAYFINDER study were presented, showing that TEZSPIRE reduces or eliminates oral cortical steroid (OCS) use in OCS-dependent patients with severe uncontrolled asthma.
FDA review of the WAYPOINT Phase 3 data in patients with chronic rhinosinusitis with nasal polyps is ongoing with a PDUFA date of October 19, 2025.
A Phase 3 study of TEZSPIRE has completed enrollment of 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.
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 of 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.
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) and in adults with refractory rheumatoid arthritis.
Inebilizumab
Inebilizumab is a B-cell depleting monoclonal antibody targeting CD19.
A Phase 2 study of inebilizumab in autoimmune disease is enrolling adults with SLE with nephritis.
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 June, Phase 1b/2 subcutaneous blinatumomab data were presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress and simultaneously published in The Lancet Haematology demonstrating 89–92% remission rates (complete remission/complete remission with partial hematological recovery rates/complete remission with incomplete count recovery) and manageable safety in adults with relapsed/refractory CD19-positive Philadelphia chromosome (Ph)-negative B-cell precursor acute lymphoblastic leukemia (B-ALL).
The dose-expansion and optimization phase of a Phase 1/2 study of subcutaneous blinatumomab is ongoing in adult patients with relapsed or refractory CD19-positive Ph-negative B-ALL. The Company is planning to initiate a potentially registration-enabling Phase 2 portion of this study in both adults and adolescents in H2 2025.
Golden Gate, a Phase 3 study of BLINCYTO alternating with low-intensity chemotherapy, is enrolling older adult patients with newly diagnosed CD19-positive Ph-negative B-ALL.
IMDELLTRA / tarlatamab
IMDELLTRA is the first and only FDA-approved delta-like ligand 3 (DLL3) targeting BiTE molecule.
In June, interim results from the global Phase 3 DeLLphi-304 trial were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting (ASCO) (Free ASCO Whitepaper) and simultaneously published in the New England Journal of Medicine. The data showed that IMDELLTRA reduced the risk of death by 40% and significantly extended median overall survival (OS) by more than five months compared to standard-of-care (SOC) chemotherapy in patients with small cell lung cancer (SCLC) who progressed on or after one line of platinum-based chemotherapy. Imdelltra significantly improved patient-reported outcomes of dyspnea and cough compared to SOC chemotherapy. The safety profile of IMDELLTRA was consistent with its known profile. Regulatory filing activities are underway.
The Company is advancing a comprehensive, global clinical development program across extensive-stage (ES) and limited-stage (LS) 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 a PD-L1 inhibitor 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 LS-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 of IMDELLTRA in second-line ES-SCLC, is enrolling patients.
DeLLphi-310, a Phase 1b study of IMDELLTRA in combination with YL201, a B7-H3 targeting antibody-drug conjugate, with or without a PD-L1 inhibitor, is enrolling patients with ES-SCLC.
DeLLphi-311, a Phase 1b study of IMDELLTRA in combination with etakafusp alfa (AB248), a novel CD8+ T-cell selective interleukin-2 (IL-2), was initiated in patients with ES-SCLC.
DeLLphi-312, a Phase 3 study of first-line IMDELLTRA in combination with carboplatin, etoposide and durvalumab, was initiated in patients with ES-SCLC.
Xaluritamig (AMG 509)
Xaluritamig is a first-in-class BiTE targeting six-transmembrane epithelial antigen of prostate 1 (STEAP1).
XALute, 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 is ongoing in patients with mCRPC who have not yet received taxane-based chemotherapy and is ongoing in 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 of 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.
Bemarituzumab
Bemarituzumab is a first-in-class fibroblast growth factor receptor 2b (FGFR2b) targeting monoclonal antibody.
In June, the Company announced the Phase 3 FORTITUDE-101 clinical trial of first-line bemarituzumab plus chemotherapy (mFOLFOX6) met its primary endpoint of OS at a pre-specified interim analysis:
Bemarituzumab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS as compared to placebo plus chemotherapy in patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction cancer with FGFR2b overexpression and who are non-HER2 positive. FGFR2b overexpression was defined as 2+/3+ staining in ≥10% of tumor cells by centrally performed immunohistochemistry testing.
The most common treatment-emergent adverse events (>25%) in patients treated with bemarituzumab plus chemotherapy were reduced visual acuity, punctate keratitis, anemia, neutropenia, nausea, corneal epithelium defect and dry eye. While ocular events were consistent with the Phase 2 experience and observed in both arms, they occurred with greater frequency and severity in the Phase 3 bemarituzumab arm.
Detailed results from FORTITUDE 101 will be shared at a future medical meeting.
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/H1 2026.
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.
AMG 193
AMG 193 is a first-in-class small molecule methylthioadenosine (MTA)-cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor.
A Phase 2 study 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 or pancreatic cancers.
Kyprolis
In May, the FDA granted pediatric exclusivity to Kyprolis for studies conducted under a Written Request and approved updates to the "Pediatric Use" subsection of the Kyprolis prescribing information.
LUMAKRAS/LUMYKRAS
In May, the FDA granted Breakthrough Therapy Designation to LUMAKRAS in combination with Vectibix and FOLFIRI for the first-line treatment of patients with KRAS G12C-mutated metastatic colorectal cancer (CRC), as determined by an FDA-approved test. This is the third Breakthrough Therapy Designation granted by the FDA for LUMAKRAS.
CodeBreaK 301, a Phase 3 study of LUMAKRAS in combination with Vectibix and FOLFIRI vs. FOLFIRI with or without bevacizumab-awwb, is enrolling patients with first-line KRAS G12C–mutated metastatic CRC.
CodeBreaK 202, 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
In June, data were presented at ASCO (Free ASCO Whitepaper) from the final analysis of RECITE, a Phase 3 study of Nplate as supportive care for chemotherapy-induced thrombocytopenia (CIT) in gastrointestinal cancers:
the study met its primary endpoint; more patients on Nplate had no chemotherapy dose modifications due to CIT compared to placebo (84.4% vs. 35.7%, Odds Ratio 10.2; P<0.001).
Nplate was well tolerated in a highly comorbid population, with no treatment-related serious adverse events or treatment-related adverse events leading to death or discontinuation of Nplate or chemotherapy.
PROCLAIM, a Phase 3 study of Nplate for the treatment of CIT, is enrolling patients with NSCLC, ovarian cancer, or breast cancer.
Biosimilars
A randomized, double-blind pharmacokinetic similarity study of ABP 206 compared with OPDIVO (nivolumab) is ongoing in 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 NSCLC 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 NSCLC.
A randomized, double-blind pharmacokinetic similarity/comparative clinical study of ABP 692 compared to OCREVUS (ocrelizumab) is 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.
YL201 is an investigational B7-H3 targeting antibody-drug conjugate being developed by MediLink.
Etakafusp alfa (AB248) is a novel CD8+ T cell selective interleukin-2 (IL-2) being developed by Asher Biotherapeutics.
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.
1 The efficacy estimand represents the efficacy as if treated participants had adhered to MariTide for the entire 52-week study period. The efficacy estimand includes endpoint data so long as study drug is taken. Where endpoint data is missing with early discontinuation, the endpoint results for the patient are estimated using individual patient response and predicted performance after drug discontinuation.