Non-Small Cell Lung Cancer (NSCLC)2026-07-26

Ivonescimab (SMT112) in NSCLC: Independent Peak Sales Estimate

Independent Revenue Model for Summit Therapeutics's Ivonescimab Peak US and Global Annual Sales

Ivonescimab Overview

After having achieved NMPA approval in China, ivonescimab (SMT112) is now under FDA review as it's poised to enter the US and global markets. Originally developed and commercialized in China by Akeso Pharma, a partnership was formed with Summit Therapeutics in 2022 to speed up remaining development and hand off ex-China commercialization.^[1]

Ivonescimab is a bispecific antibody targeting both PD-1 and VEGF to achieve simultaneous immune checkpoint and angiogenesis inhibition for greater anti-tumor effects than traditional PD-1s like pembrolizumab.^[2] The therapy's breakthrough data came in the phase 3 Harmoni-2 study, where risk of death or progression was reduced by 49% and PFS was almost double that of pembrolizumab.^[3]^[4] Such drastic improvements over the gold standard therapy across dozens of oncology treatments is a remarkable achievement and has huge implications for the revenue potential of ivonescimab.

To estimate the revenue potential, we've developed a peak annual sales model. Each model input is broken out and traced to credible academic or industry data sources. Scenario analyses are included, exploring different indication expansion scenarios at the time of peak sales, as well as scenarios varying the market share model parameter which carries some of the higest uncertainty in the model. Most importantly, the model is dynamic, allowing you to plug in your own values for any parameter to generate the most useful estimate.

Analyst Forecasts

Publicly available analyst estimates of peak annual sales are sparse and wide ranging. Below is the set of available estimates, with the geographic scope and target patient population specified when available.

Source	Estimate	Scope	Credibility
SeekingAlpha^[5]	$400 million	US only, 2L EGFR-mutant NSCLC	High - Robust analytical breakdown from a reputable source
Goldman Sachs, cited by Allmind^[6] and The Bamboo Works^[7]	$53 billion	Global, multi-indication across oncology; peak sales year estimated as 2041	High - Assuming proper attribution, analysis comes from a prestigious investment bank
Clinical Trials Arena / GlobalData^[8], also cited by MedPath^[9]	$1.7 billion	Global, not defined as peak sales but as a 2030 sales estimate	High - Figure cited multiple times and generated from an industry trusted pharma intelligence source
Evaluate Pharma, cited by FierceBiotech^[10]	$8.5 billion	Geography not specified; figure is an estimate for 2032, not defined as the peak sales year	High - Figure generated by an established competitive intelligence firm and cited by a very reputable pharma news source
SimplyWall St^[11]	$3.1 billion	Not a peak sales estimate but a 2029 revenue estimate (approximately 2 years after launch); assumed global sales	High - Reputable data aggregator, citing a financial analyst estimate figure, although the analyst group is not specified
KoalaGains^[12]	$4-6 billion	Unspecified	Low - Not a well established source, with no citation or methodology provided
Sahm^[13]	$70 billion	Unspecified; assume global cumulative sales	Low - Appears to be a well established firm in Saudi Arabia, but global credibility could not be determined
Options Cafe^[14]	$4.7 billion	Consensus revenue estimate, not peak sales; geographic scope unspecified	Low - Not a well established source, with no citation or methodology provided on the estimate

Across the estimates generated above, SeekingAlpha's analysis appears to be the most robust, with a full breakdown of their risk-adjusted Net Present Value Model (rNPV). This estimate however only covers the first narrow indication that ivonescimab is pursuing, whereas at the time of peak sales the therapy is likely to have broader NSCLC approval as well as expansions into numerous oncology indications given its breakthrough clinical outcomes.

Note: Most, if not all, global estimates are based on Summit Therapeutics' revenue potential for ivonescimab. This excludes China-based revenue, the commercial rights to which belong to Akeso, the original developer of the therapy. The Chinese market tends to account for 5% of global revenue for therapies.^[39]

Model Schematic

Below is a conceptual breakdown of how the model arrives at its peak annual sales estimates.

Eligible Patient Population

{

NSCLC Incidence

Nonsquamous Rate

EGFR Positive Rate

Advanced / Metastatic Rate

TKIs as 1L Received Rate

2L Treatment Rate

For the base case of the model, broad NSCLC approval is assumed, so all other subtype filters are turned off in the calculation.

Cost of Treatment

{

Avg Annual NSCLC Treatment Cost

Avg GTN Ratio Oncology

Avg Duration of Ivonescimab Treatment

Anticipated Market Share

→

US Peak Sales

US : Global Revenue Ratio

→

Global Peak Sales

Annual Peak Sales Estimation Model

The model below estimates peak sales for ivonescimab in the US and globally. While ivonescimab's first target indication is narrow (treatment of patients with EGFR-mutated, locally advanced or metastatic nonsquamous NSCLC whose disease has progressed after third-generation tyrosine kinase inhibitor (TKI) therapy), approval in NSCLC is likely to be much broader by the time of peak sales. Thus, the model's default parameters have been set to a broad NSCLC approval which is very probable given the superiority in clinical data versus current SOC pembrolizumab.

However, NSCLC patient subtype parameters in the model can be toggled on and off to generate peak sales estimates for varying degrees of indication expansion within NSCLC.

The peak annual sales model is interactive and any parameter value can be adjusted. The outputs will update automatically based on input parameter changes. Feel free to modify inputs risk free as the original model values can all be restored when you hit the “Reset to Defaults” orange button.

Interactive Peak Sales Calculator

Input Parameters

NSCLC Incidence

Annual incidence calculated as: 229,410 new lung cancer cases^[15] × 77% NSCLC proportion^[15] ≈ 176,645^[16]

Source: SEER 2026^[15] · ACS 2025^[16]

NSCLC Subtype Filters

Nonsquamous NSCLC rate%

SEER Data^[17]

EGFR mutated NSCLC rate%

Zhang et al. 2016^[18]

Advanced / metastatic rate%

CDC US Cancer Statistics^[20]

EGFR positive NSCLC patients that receive TKIs as 1L%

Subramanian et al. 2025^[21]

Advanced NSCLC patients that receive 2L treatment%

Divan et al. 2024^[22]

Annual Cost of NSCLC Treatment (USD)

Source: Cheng et al. ISPOR Poster^[23] · Pharma PPI^[24]

Average GTN Ratio for Oncology (%)

Source: L.E.K. 2024^[27]

Average Duration of Ivonescimab Treatment (% of one year)

Source: Fang et al. 2024^[29]

Anticipated Market Share: 35%

0%20%conservative50%optimistic70%100%

Source: Citibank via Investing.com^[30]

US Revenue as % of Global

Source: Ramagopalan et al. 2025^[33]

Live Outputs

Eligible Patient Population

176,645

US Peak Annual Sales Estimate

$6.49B

Global Peak Annual Sales Estimate

$11.00B

Model Parameter Descriptions and Assumptions

Calculated from SEER-reported total lung cancer incidence of 229,410 cases in 2026 ^[15], of which approximately 77% are non-small cell lung cancer, yielding 176,645 ^[15]^[16]. This figure is corroborated by American Cancer Society data ^[16] and is used as the top-down incidence estimate for the model.

Calculated as the rate of adenocarcinoma plus large cell carcinoma divided by the rate of all three major NSCLC subtypes (adenocarcinoma, large cell carcinoma, and squamous cell carcinoma) ^[17]. Ivonescimab's initial FDA submission targets nonsquamous NSCLC.

Zhang et al.'s systematic review and meta-analysis found an EGFR mutation rate of 24.4% in NSCLC patients for North and South America ^[18]. Since this peak sales model is largely US-based, the Americas-specific figure is used rather than the higher 32.3% global rate the analysis also found, which is primarily driven by East Asia. Because Chinese commercial rights do not belong to Summit Therapeutics, the Americas rate is the more relevant figure.

Other sources state EGFR mutation rates as low as 15% for the US ^[19], which would meaningfully shrink the eligible population; this lower rate can be scenario tested by changing the model input above.

Sum of regional- and distant-stage lung cancers at diagnosis, per CDC US Cancer Statistics ^[20]. This figure covers all lung cancers rather than NSCLC specifically, but should still be broadly applicable given most lung cancers are NSCLC rather than small cell lung cancer.

Real-world data indicates approximately 75% of EGFR-positive NSCLC patients receive a tyrosine kinase inhibitor (TKI) as first-line therapy ^[21]. Ivonescimab's initial FDA approval targets patients after progression on a prior EGFR TKI, making this a necessary population criteria to include.

Real-world treatment pattern data indicates that approximately 24.4% of advanced NSCLC patients go on to receive second-line therapy (see table 1 in Divan et al.) ^[22]. This is another criteria included in Ivonescimab's initial FDA submission, which targets the second-line, post-TKI setting.

Cheng et al. reports a range of $190,000 to $281,000 (as of 2023) for annual NSCLC treatment cost, with EGFR-targeted therapies spanning the full range ^[23]. The midpoint of this range is $235,500. Adjusting this value using the Pharma Producer Price Index from June 2023 to June 2026 ^[24] yields $245,000. The ISPOR source also notes that novel NSCLC therapies were launched at comparable prices, increasing confidence in this benchmark for ivonescimab and other future NSCLC therapy pricing.

An alternative source (Alwatari et al.) lists an extremely wide range of $33,000 to $556,000 ^[25], but this figure is reported per person rather than per year and is not used in the model. A separate ICER publication estimates a lower figure of $90,000 per person for 1L TKI therapies ^[26], which, inflated from 2016 to 2026 using the Pharma PPI ^[24], comes out to approximately $119,000 and can be tested in the model as a conservative scenario estimate.

GTN-retained percentage is calculated as 1 minus the gross-to-net (GTN) deduction. L.E.K.'s analysis across 30 oncology products found a mean GTN deduction of 16%, implying an 84% GTN-retained rate ^[27]. Oncology tends to have better GTN margins than the broader pharmaceutical market.

A separate Keytruda-specific source estimates GTN deduction at 6 to 14% ^[28], which would place the GTN-retained rate at 86 to 94%, modestly above the 84% base case.

Based on a clinical trial of ivonescimab, average treatment duration was 8.8 cycles ^[29]. At 3 weeks per cycle, that is 26.4 weeks, or approximately 51% of a year.

This estimate is currently based on a single data source; additional corroborating datapoints could further refine this assumption.

Citibank's analysis pegs the estimated market share at 35% for ivonescimab in squamous NSCLC ^[30]. Additional sources indicate that for a first-in-class therapy targeting a high unmet need indication, anywhere from 30 to 50% market share at time of peak sales is reasonable ^[31]. Ivonescimab is first-in-class, and NSCLC remains a relatively high unmet need area, so the lower end of the 30 to 50% range (35%) is used as the base case, corroborating Citibank's analysis.

A separate source indicates that around 40% market share is reasonable for a first-in-class therapy ^[32]. Market share carries some of the widest uncertainty in the model: physician reaction, commercial strategy, additional clinical studies, salesforce strategy, and many other factors can all impact market share for the therapy.

Ramagopalan et al. identified the US versus rest-of-world revenue breakdown for key blockbuster drugs including Keytruda and Xarelto ^[33]. Additional oncology therapies were included in the underlying analysis but were indicated for rare oncology indications with much larger portions of ex-US revenue; since ivonescimab is pursuing a prevalent oncology indication with blockbuster potential, those therapies were not considered suitable analogues.

A further adjustment may be warranted to reflect that Summit Therapeutics does not hold Chinese commercial rights, which are retained by Akeso. This adjustment is not applied in the base case, although revenue in the Chinese market often accounts for a relatively small portion of total global revenue.

Scenario Analysis: Indication Expansion

While the model estimates peak annual sales based on ivonescimab's approval in NSCLC, the potential breakthrough therapy is likely to expand into other relevant cancer types. There is an extensive set of clinical trials currently underway for ivonescimab, clearly suggesting Summit's plans for rapid multi-indication expansion.

Summit has additional phase 3 trials planned or underway in Colorectal, Pancreatic, and Squamous Cell Carcinoma Head and Neck cancers.^[34] There are nearly 100 additional phase 2 trials also underway or planned, most of them based in the US, which are studying Endometrial / Cervical, Glioblastoma, Renal Cell Carcinoma, Breast, Esophageal Squamous Cell Carcinoma, Small Cell Lung, Solid Tumor, Ovarian, and Thymic cancers, along with at least six other cancer types not listed here.^[35]

Due to the high likelihood of the therapy having multiple indications on-label at the time of peak sales, below are various plausible indication expansion scenario analyses for ivonescimab.

Scenario	Label	Rationale	Peak Annual Sales Estimate
Extremely conservative	Narrow NSCLC approval based on the current FDA submission (EGFR-mutated, adv / mets nonsquamous NSCLC, progressed after TKI)	While this is a highly unlikely scenario, it represents the peak sales potential that is closest to being realized based on the current BLA application with the FDA.	US $129.3M / Global $219.1M (to replicate this estimate, check all five NSCLC subtype filters in the calculator)
Conservative	Broad NSCLC approval, including all subtypes and lines of therapy	Broad NSCLC approval is highly probable given the therapy's promising clinical outcomes in NSCLC and against SOC.	US $6.49B / Global $11.00B (this is the model's default state, with all NSCLC subtype filters unchecked)
Cautiously optimistic	NSCLC and Colorectal, Pancreatic, SCCHN approvals	These cancer types are all in phase 3 ivonescimab trials and most likely to receive FDA approval by the time of peak sales.	US $10.72B / Global $18.16B
Optimistic*	Approvals in 20 distinct cancer types	Keytruda currently has FDA approval in 20+ distinct cancers, serving as the benchmark for an optimistic peak sales indication expansion scenario.	US $33.26B / Global $56.37B

*For the optimistic scenario, 19 additional indications were used to calculate the multiplier, on top of NSCLC itself, for a total of 20 distinct cancer types, matching a rough estimate of the number of cancer types where Keytruda is on-label (not to be confused with 40+ specific indication approvals across these 20+ cancer types).^[38] Keytruda has not yet reached peak sales, making its current indication breadth a reasonable directional benchmark for ivonescimab's optimistic, most bullish long-term scenario.

Calculation Methodology and Assumptions

While the extremely conservative and conservative scenario estimates can be generated from the model above, the cautiously optimistic and optimistic peak sales estimates were calculated using a simplified, high-level approach to estimate additional revenue in indications beyond NSCLC.

The NSCLC incidence (176,645) was compared to the average incidence amongst a broad list of 29 different prominent cancer types in the US (38,349), generating a comparison ratio of 0.22.^[36] (For more details on how this average incidence value was generated, see Appendix A Dropdown below.)

For each additional cancer type in the cautiously optimistic (n=3) and optimistic (n=19) scenarios, 22% of ivonescimab's revenue in NSCLC was added to the existing NSCLC-driven revenue.

The diagram below illustrates this calculation for the two optimistic scenarios:

Optimistic Peak Sales

NSCLC-Driven Revenue

+ nΣ [ (

Avg Incidence of Expansion Indications

Incidence of NSCLC

) ×

NSCLC-Driven Revenue

]

These estimates where NSCLC drives a disproportionately high portion of the revenue fall in line with Keytruda's revenue distribution, for which roughly $12 billion of the therapy's $30 billion in 2025 sales (39.7%) came from NSCLC treatment.^[37] This comparison of Keytruda to Ivonescimab NSCLC revenue is apt given the indication is targeted early in both drugs' life cycles (second approval for Keytruda and likely first for Ivonescimab).

Below are additional assumptions made in these calculations:

Ivonescimab becomes the frontline standard of care in each expansion indication, similar to how it is in the base case model for NSCLC.
Market share is assumed to be constant across the cancer types, which is going to overestimate peak sales, since at the time of peak sales, uptake in more recently approved indications is likely to be less saturated than in earlier approved indications, meaning the same level of market share as NSCLC would be difficult to achieve.
Eligibility across patient subtypes in each of these cancers was also assumed to be broad for simplicity, even though that is likely not to be the case across all of these cancers, even if it ends up being so in NSCLC. This also leads to an overestimation.

Overall, these two scenarios are very likely to be overestimates, and mainly serve to provide directional insight into annual revenue potential if Keytruda-like indication expansion is achieved.

Appendix A: Average Oncology Incidence Calculation

In order to generate an average cancer incidence value, the following data from the American Cancer Society's Cancer Facts and Figures 2026 report was used:^[36]

Cancer Type	Incidence Rate
Tongue	20,420
Mouth	15,810
Pharynx	21,760
Other oral cavity	2,490
Esophagus	22,530
Stomach	31,510
Small intestine	14,450
Colon	108,860
Rectum	49,990
Anus, anal canal, & anorectum	11,270
Liver & intrahepatic bile duct	42,340
Gallbladder & other biliary	12,640
Pancreas	67,530
Other digestive organs	8,850
Larynx	12,290
Lung & bronchus	229,410
Other respiratory organs	6,120
Bones & joints	4,110
Soft tissue (including heart)	13,910
Melanoma of the skin	112,000
Other nonepithelial skin	7,750
Breast	324,580
Uterine cervix	13,490
Uterine corpus	68,270
Ovary	21,010
Vulva	7,130
Vagina & other genital, female	7,760
Prostate	333,830
Testis	9,810
Penis & other genital, male	2,260
Urinary bladder	84,530
Kidney & renal pelvis	80,450
Ureter & other urinary organs	4,720
Eye & orbit	3,200
Brain & other nervous system	24,740
Thyroid	45,240
Other endocrine	7,960
Hodgkin lymphoma	8,920
Non-Hodgkin lymphoma	79,320
Myeloma	36,000
Acute lymphocytic leukemia	6,250
Chronic lymphocytic leukemia	22,760
Acute myeloid leukemia	22,720
Chronic myeloid leukemia	9,650
Other leukemia	6,410
Other & unspecified primary sites	67,800
Sum (n = 46)	2,114,850
Average	45,975

Certain cancers listed in this table were grouped together to form meaningful cancer type categories, generating the modified table below.

Cancer Type	Incidence Rate
Colorectal	158,850
Melanoma of the skin	112,000
Urothelial (bladder + ureter)	89,250
Kidney / renal pelvis	80,450
Non-Hodgkin lymphoma	79,320
Head & neck SCC	72,770
Uterine corpus	68,270
Pancreas	67,530
Thyroid	45,240
Liver & intrahepatic bile duct	42,340
Myeloma	36,000
Stomach	31,510
Brain & other CNS	24,740
CLL	22,760
AML	22,720
Esophagus	22,530
Ovary	21,010
Small intestine	14,450
Soft tissue sarcoma	13,910
Uterine cervix	13,490
Gallbladder & other biliary	12,640
Anus	11,270
Testis	9,810
CML	9,650
Hodgkin lymphoma	8,920
Vulva	7,130
ALL	6,250
Bones & joints	4,110
Eye & orbit	3,200
Sum (n = 29)	1,112,120
Average	38,349
Median	22,720

These incidence rates were averaged to yield the value 38,349.

Prostate, breast, and lung cancer were excluded from the average calculation. These three cancers drive the highest incidence rates in the US and would have disproportionately skewed the average too high. Most of ivonescimab's indication expansions will be in these lower-incidence cancer types. While the drug is also being tested in trials that include breast and prostate cancer, the breadth of market penetration in those indications likely will never reach that of NSCLC, further justifying their exclusion from the average calculation.

Market share is the model parameter with the highest amount of uncertainty, given the multitude of factors that impact a novel therapeutic's uptake and physician adoption. Due to the high variability that can be expected, below are the conservative and optimistic cases alongside the default base case presented in the model.

Scenario	Market Share Value	Annual Peak Sales Estimate
Conservative	20%	US $3.71B / Global $6.28B
Base Case	35%	US $6.49B / Global $11.00B
Optimistic	50%	US $9.27B / Global $15.71B

Concluding Remarks

Ivonescimab's clinical data suggests it has the potential to be Keytruda's incumbent across much of the oncology treatment landscape. Peak sales estimates rely on and fall in line with the actualized revenue that Keytruda has experienced over the last decade, with some of the more optimistic bull cases suggesting even higher annual revenue figures. Ivonescimab has all the makings to be a bispecfic blockbuster therapy, building upon the innovation of first generation checkpoint inhibitor therapies and further improving survival outcomes for patients suffering from deadly malignancies.

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References(click to expand)

[1]“Akeso Inc. Announces Collaboration and License Agreement for Up to US$5 Billion with Summit Therapeutics to Accelerate Global Development and Commercialization of its Breakthrough Bispecific Antibody, Ivonescimab (PD-1/VEGF)” · Akeso, Inc. · December 6, 2022 View source
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