Category: QuickView

Daraxonrasib vs Chemotherapy in Previously Treated Metastatic Pancreatic Cancer (RASolute3o2)

ASCO Annual Meeting 2026

RASolute 302

Daraxonrasib versus chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma. Phase 3, open-label, randomized.

Total N

500

248 vs 252; 91.8% RAS G12

Primary endpoint

OS & PFS

RAS G12 population

OS hazard ratio

0.40

95% CI 0.30 to 0.53

ORR

31.6%

vs 11.2%, overall pop.

Trial design

RASolute 302 was a phase 3, international, open-label, randomized trial conducted at 59 sites in six countries. Enrollment ran from October 16, 2024 to November 7, 2025. Patients were randomly assigned 1:1. Crossover to the other group was not permitted. An independent data monitoring committee oversaw safety.

Treatment arms

Daraxonrasib (n=248)

300 mg orally once daily. An oral RAS(ON) multiselective tri-complex inhibitor of the GTP-bound state of mutant and wild-type RAS. Treatment continued until disease progression, unacceptable toxicity, or consent withdrawal.

Investigator’s choice chemotherapy (n=252)

One of four regimens, given per local prescribing practice: gemcitabine plus nab-paclitaxel; modified FOLFIRINOX; FOLFOX; or liposomal irinotecan plus fluorouracil and leucovorin.

Key eligibility

Age: at least 18 years
Disease: histologically or cytologically confirmed mPDAC with measurable disease per RECIST v1.1
Prior therapy: progression after one prior line of fluoropyrimidine- or gemcitabine-based therapy for metastatic disease (or progression less than 6 months after neoadjuvant/adjuvant therapy)
Performance status: ECOG 0 or 1
RAS status: documented tumor RAS mutational status by local testing (KRAS, NRAS, or HRAS at codon 12, 13, or 61, or no RAS mutation identified)
Key exclusions: known CNS metastases; prior RAS-targeted therapy

Stratification factors

ECOG performance status (0 vs 1)
Metastatic disease at initial diagnosis (yes vs no)
Liver metastases at baseline (yes vs no)
Tumor RAS mutational status (RAS G12D/V vs other RAS G12 vs RAS G13 or Q61 or no RAS mutation identified)

Endpoints

Dual primary

Overall survival (OS) and progression-free survival (PFS) by blinded independent central review (BICR) per RECIST v1.1, in the RAS G12 population.

Key secondary

OS and PFS in the overall population; objective response rate (ORR) in the RAS G12 and overall populations; patient-reported time to deterioration (TTD) in pain and in global health status/quality of life, in both populations.

Additional secondary

Time to response and safety. Adverse events graded per NCI CTCAE v5.0.

The overall population included patients with RAS G12, G13, or Q61 mutations or with no RAS mutation identified. The RAS G12 population (459 patients, 91.8%) comprised those with RAS G12 mutations.

Analysis timing Data reported are from the first interim OS analysis (IA1), which was also the final PFS analysis, performed after enrollment completion and at least 166 deaths in the RAS G12 population. Data cutoff: February 10, 2026. Median follow-up: 8.5 months (range 3.2 to 15.9).

Overall survival

Population	Events, n (%)	Median OS, mo (95% CI)	HR (95% CI)	P value
RAS G12 · Daraxonrasib (n=228)	72 (32)	13.2 (10.0–NE)	0.40 (0.30–0.54)	P<0.001 5.9×10⁻¹⁰
RAS G12 · Chemotherapy (n=231)	127 (55)	6.6 (5.4–8.2)	0.40 (0.30–0.54)	P<0.001 5.9×10⁻¹⁰
Overall · Daraxonrasib (n=248)	79 (32)	13.2 (10.0–NE)	0.40 (0.30–0.53)	P<0.001 4.6×10⁻¹¹
Overall · Chemotherapy (n=252)	141 (56)	6.7 (5.8–8.0)	0.40 (0.30–0.53)	P<0.001 4.6×10⁻¹¹

NE = not estimable. HR by stratified Cox model.

53.2%

12-mo OS, daraxonrasib (overall pop.)

17.3%

12-mo OS, chemotherapy (overall pop.)

60%

Reduction in risk of death (both pops.)

RAS G12 12-month OS: 53.3% vs 18.7%.

Progression-free survival (BICR)

Population	Events, n (%)	Median PFS, mo (95% CI)	HR (95% CI)	P value
RAS G12 · Daraxonrasib (n=228)	112 (49)	7.3 (6.3–8.1)	0.45 (0.34–0.59)	P<0.001 3.2×10⁻⁹
RAS G12 · Chemotherapy (n=231)	121 (52)	3.5 (2.9–3.8)	0.45 (0.34–0.59)	P<0.001 3.2×10⁻⁹
Overall · Daraxonrasib (n=248)	127 (51)	7.2 (5.7–7.5)	0.49 (0.38–0.64)	P<0.001 5.2×10⁻⁸
Overall · Chemotherapy (n=252)	130 (52)	3.6 (2.9–4.2)	0.49 (0.38–0.64)	P<0.001 5.2×10⁻⁸

6-month PFS (RAS G12): 58.7% vs 31.7%. 6-month PFS (overall): 56.0% vs 32.9%.

Objective response (confirmed, BICR)

RAS G12 population

33.2%

Daraxonrasib (n=237)
95% CI 27.0–39.9

11.8%

Chemotherapy (n=221)
95% CI 7.8–16.8

Overall population

31.6%

Daraxonrasib (n=248)
95% CI 25.8–38.0

11.2%

Chemotherapy (n=252)
95% CI 7.5–15.9

Both comparisons P<0.0001. Median time to response was 1.9 months in both groups. ORR denominators are patients with measurable disease at baseline per BICR (RAS G12: daraxonrasib 237, chemotherapy 221; overall: 248 and 252). Duration of response and tumor-shrinkage (waterfall) data were not reported in the available sources.

Overall survival subgroups (overall population)

Hazard ratios and 95% CIs by unstratified Cox model. The unstratified “Overall” HR is 0.42 (0.32 to 0.55); the headline stratified HR is 0.40 (0.30 to 0.53). Events shown as daraxonrasib / chemotherapy. Point size is not scaled here; n’s appear on every row.

Patient-reported time to deterioration (overall population)

Measure	Daraxonrasib, mo	Chemotherapy, mo	HR (95% CI)	P value
Pain (EORTC QLQ-PAN26)	9.2	3.8	0.51 (0.37–0.71)	P<0.001
Global health status / QoL (QLQ-C30)	5.7	2.6	0.60 (0.46–0.79)	P<0.001

RAS G12 pain medians were 9.0 vs 3.7 months; GHS/QoL 5.6 vs 2.4 months.

Note on attribution The overview table below reports treatment-related adverse events (TRAEs) except the first two rows, which are all-cause treatment-emergent (TEAE). The bar chart reports TRAEs.

Safety overview

Event	Daraxonrasib (n=241)	Chemotherapy (n=214)
Median time on treatment, mo	6.2	1.5–3.2*
Any TEAE (all-cause), n (%)	241 (100)	209 (97.7)
Grade ≥3 TEAE (all-cause), n (%)	149 (61.8)	149 (69.6)
Any TRAE, n (%)	236 (97.9)	200 (93.5)
Grade ≥3 TRAE, n (%)	105 (43.6)	123 (57.5)
Serious TRAE, n (%)	26 (10.8)	40 (18.7)
TRAE leading to dose reduction, n (%)	87 (36.1)	123 (57.5)
TRAE leading to dose interruption, n (%)	135 (56.0)	118 (55.1)
TRAE leading to discontinuation, n (%)	3 (1.2)	24 (11.2)
Grade 5 (fatal) TRAE, n (%)	1 (0.4)	0

*Chemotherapy median time on treatment is reported as a range across the four component regimens. One daraxonrasib patient died of treatment-related pneumonitis (the single grade 5 TRAE). Median dose intensity: 93.1% daraxonrasib vs 65.3 to 95.0% across chemotherapy regimens.

Treatment-related adverse events (any grade) in ≥20% of either arm

Daraxonrasib, any grade Daraxonrasib, grade ≥3 Chemotherapy, any grade Chemotherapy, grade ≥3

Any-grade incidence with grade ≥3 in parentheses. Threshold: any-grade incidence at least 20% in either arm. Grade ≥3 bars overlay the any-grade bar. Several terms are grouped composites (for example, rash, stomatitis, neutropenia, thrombocytopenia, and peripheral neuropathy).

Most common events by arm

Daraxonrasib (TRAE, any grade)

Rash 85.5%, diarrhea 58.1%, stomatitis 53.1%, nausea 46.5%, vomiting 36.9%. Mostly low-grade dermatologic and gastrointestinal events; grade ≥3 rash 13.7% and stomatitis 12.0% were the only grade ≥3 TRAEs at 10% or higher. No grade 4 TRAEs except as noted; one grade 5.

Chemotherapy (TRAE, any grade)

Fatigue 44.4%, anemia 39.7%, nausea 39.3%, neutropenia 38.3%, diarrhea 37.9%, thrombocytopenia 33.2%, peripheral neuropathy 25.2%. Grade ≥3 TRAEs at 10% or higher: neutropenia 27.6% and anemia 16.4%.

Primary sources

Journal article. O’Reilly EM, Wainberg ZA, Hendifar AE, et al. Daraxonrasib or chemotherapy in previously treated metastatic pancreatic cancer. N Engl J Med. Published online May 31, 2026. DOI: 10.1056/NEJMoa2605555.

Conference presentation. Wolpin BM, et al. Daraxonrasib, a RAS(ON) multiselective inhibitor versus chemotherapy in previously treated mPDAC: primary and final analysis from the phase 3 RASolute 302 study. Presented at the ASCO Annual Meeting 2026, Chicago.

Trial registration. ClinicalTrials.gov identifier NCT06625320. Sponsor: Revolution Medicines.

Abbreviations

AE — adverse event

ALT — alanine aminotransferase

AST — aspartate aminotransferase

BICR — blinded independent central review

CI — confidence interval

CNS — central nervous system

CR — complete response

CTCAE — Common Terminology Criteria for Adverse Events

DoR — duration of response

ECOG PS — Eastern Cooperative Oncology Group performance status

EORTC QLQ-C30 — EORTC Core Quality of Life Questionnaire

EORTC QLQ-PAN26 — EORTC pancreatic cancer module

FOLFOX — leucovorin, fluorouracil, oxaliplatin

GHS — global health status

GnP — gemcitabine plus nab-paclitaxel

GTP — guanosine triphosphate

HR — hazard ratio

mFOLFIRINOX — modified fluorouracil, irinotecan, leucovorin, oxaliplatin

mPDAC — metastatic pancreatic ductal adenocarcinoma

Nal-IRI — nanoliposomal irinotecan

NE — not estimable

ORR — objective response rate

OS — overall survival

PFS — progression-free survival

PO QD — orally once daily

PR — partial response

PRO — patient-reported outcome

QoL — quality of life

RECIST — Response Evaluation Criteria in Solid Tumors

TEAE — treatment-emergent adverse event

TRAE — treatment-related adverse event

TTD — time to deterioration

Cancer Communicator QuickView. Data reference tool compiled from the published NEJM article and the ASCO 2026 presentation for RASolute 302 (NCT06625320). Data cutoff February 10, 2026. Funded by Revolution Medicines. This summary is for educational purposes and is not medical advice.

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May 31, 2026

QuickView: Abemaciclib vs Placebo in Advanced Dedifferentiated Liposarcoma (SARC041)

ASCO 2026 Annual Meeting · Plenary

SARC041

Abemaciclib versus placebo in advanced dedifferentiated liposarcoma. A phase 3 randomized, double-blind trial.

108Total randomized

PFSPrimary end point

0.38PFS hazard ratio

9%ORR, abemaciclib

Background and design

SARC041 was an investigator-initiated phase 3 randomized, double-blind trial sponsored by the Sarcoma Alliance for Research through Collaboration (SARC). It tested abemaciclib, an oral CDK4/6 inhibitor, against placebo in patients with advanced dedifferentiated liposarcoma, a sarcoma subtype marked by near-universal high-level CDK4 amplification. Enrollment was conducted in the United States. Patients who progressed on placebo could cross over to open-label abemaciclib.

Key eligibility

Age 18 years or older
ECOG performance status 0 to 1
Recurrent or metastatic dedifferentiated liposarcoma (purely well-differentiated disease excluded)
Disease progression by RECIST 1.1 within the 6 months before study entry
Any number of prior therapies, including none
Excluded: extensive disease needing immediate treatment

Randomization

Patients were randomized 1:1, stratified by prior systemic treatment (0 versus 1 or more lines).

Abemaciclib (n = 54)

200 mg orally twice daily, continuous

Placebo (n = 54)

200 mg orally twice daily; crossover to abemaciclib permitted on progression

Imaging by CT every 6 weeks for 36 weeks, then every 12 weeks.

End points

PrimaryProgression-free survival (PFS)

SecondaryObjective response rate; PFS after crossover for patients initially randomized to placebo; overall survival; toxicity (CTCAE v5)

ExploratoryPFS by prior therapy (0 versus 1 or more prior lines)

Statistical plan

The target sample size was 108 evaluable patients (54 per arm), providing 80% power to detect a hazard ratio of 0.6 for PFS. The design assumed a median PFS of 3.3 months in the placebo arm; a hazard ratio of 0.6 corresponded to a median PFS of 5.4 months in the abemaciclib arm.

Baseline characteristics

Characteristic	Placebo (N = 54)	Abemaciclib (N = 54)
Sex
Female	25 (46%)	17 (31%)
Male	29 (54%)	37 (69%)
Tumor location at diagnosis
Abdomen / retroperitoneum	43 (80%)	49 (92%)
Chest	4 (7.5%)	1 (1.9%)
Lower extremity	7 (13%)	3 (5.7%)
Spine	0 (0%)	1 (1.9%)
Age at enrollment
Median (range)	67 (41 to 84)	67 (19 to 84)
Prior lines of therapy
0	28 (52%)	27 (50%)
1 or more	26 (48%)	27 (50%)

Primary end point: progression-free survival

9.7 moMedian PFS, abemaciclib

1.5 moMedian PFS, placebo

0.38Hazard ratio (90% CI, 0.25 to 0.59)

Stratified log-rank P less than 0.001.

Landmark PFS	Abemaciclib	Placebo
6-month PFS	60%	22%
12-month PFS	39%	13%

Objective response rate

9%ORR, abemaciclib

0%ORR, placebo

Response measured by RECIST percent change from baseline. Confidence intervals and odds ratio for ORR were not reported in the source.

PFS after crossover

Of placebo-arm patients, 46 (85%) received abemaciclib after progression.

3.4 moMedian PFS after crossover

4%Response rate after crossover

Overall survival

NRMedian OS, abemaciclib (not reached)

25.5 moMedian OS, placebo

0.55Hazard ratio (95% CI, 0.28 to 1.07)

Stratified log-rank P equals 0.07. OS was assessed despite 85% crossover from placebo to abemaciclib.

Landmark OS	Abemaciclib	Placebo
12-month OS	85%	71%
24-month OS	72%	51%

Exploratory: PFS by prior therapy (abemaciclib arm)

Among patients receiving abemaciclib, those with no prior lines of therapy had longer median PFS than those with one or more prior lines. This forest-style comparison uses the only two subgroups and the at-risk counts reported in the source.

Subgroup (abemaciclib only)

Median PFS (months)

mPFS

No prior lines of therapy

16.4

1 or more prior lines of therapy

5.3

Log-rank P equals 0.029. Bars are scaled to median PFS; a per-subgroup hazard ratio and confidence interval were not reported. The two n values (27 and 27) are the at-risk counts at time zero shown in the source figure.

Tolerability overview

39%Dose reductions, abemaciclib

2%Dose reductions, placebo

The source reported selected adverse events by grade and dose-reduction rates. A summary of any-grade AEs, overall grade 3 or higher AEs, treatment-related versus all-cause attribution, and fatal events was not presented in the source.

Key adverse events by grade

Values are percentages. The source did not separate treatment-related from all-cause events.

Adverse event	Placebo			Abemaciclib
Adverse event	G2	G3	G4	G2	G3	G4
Hematologic
Anemia	2	—	—	22	4	—
Lymphocyte count decreased	2	—	—	7	—	2
Neutrophil count decreased	2	—	—	9	11	2
Platelet count decreased	—	—	—	—	4	—
White blood cell decreased	—	—	—	13	7	—
Gastrointestinal and other
Abdominal pain or fullness	6	4	—	4	2	—
Diarrhea	2	—	—	28	7	—
Creatinine increased	4	2	—	20	6	—

Events at 20% or higher in either arm (any reported grade)

Bars sum the grade 2 to 4 percentages reported for each event. Diarrhea, anemia, and creatinine increased reached the 20% threshold in the abemaciclib arm; no listed event reached 20% with placebo.

Diarrhea

Abema 35%

Placebo 2%

Anemia

Abema 26%

Placebo 2%

Creatinine increased

Abema 26%

Placebo 6%

Per-event totals are the sum of reported grade 2 to 4 values: diarrhea 28 plus 7 equals 35; anemia 22 plus 4 equals 26; creatinine increased 20 plus 6 equals 26. Grade 1 events were not reported, so true any-grade rates may be higher.

References

Dickson MA, Ballman KV, Weiss M, et al. SARC041: a phase 3 randomized double-blind study of abemaciclib versus placebo in patients with advanced dedifferentiated liposarcoma. Presented at: 2026 ASCO Annual Meeting (Plenary Session); May 29 to June 2, 2026; Chicago, IL.
SARC041: study of abemaciclib versus placebo in patients with advanced dedifferentiated liposarcoma. ClinicalTrials.gov identifier: NCT04967521.

No peer-reviewed journal publication was available at the time this QuickView was prepared. All efficacy and safety values are drawn from the ASCO 2026 presentation and should be confirmed against the full publication when released.

Abbreviations

AE: adverse event
CDK4/6: cyclin-dependent kinase 4 and 6
CI: confidence interval
CT: computed tomography
CTCAE: Common Terminology Criteria for Adverse Events
DDLS: dedifferentiated liposarcoma
ECOG PS: Eastern Cooperative Oncology Group performance status
HR: hazard ratio
mPFS: median progression-free survival
NR: not reached
ORR: objective response rate
OS: overall survival
PFS: progression-free survival
PO bid: orally twice daily
RECIST: Response Evaluation Criteria in Solid Tumors

Cancer Communicator QuickView. Editorial summary for medical education. Not promotional material.

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May 31, 2026

QuickView: Sunvozertinib vs Chemotherapy in Advanced NSCLC with EGFR Exon 20 Insertion (WU-KONG28)

WU-KONG28 ASCO 2026

Sunvozertinib vs platinum-based chemotherapy · First-line advanced NSCLC with EGFR exon20ins · International randomized phase 3

Total N

324

1:1 randomized

Median PFS

10.3 vs 7.5 mo

Sunvo vs Chemo

Hazard Ratio

0.65

95% CI 0.50–0.85 · P<0.001

Confirmed ORR

58.9% vs 31.1%

Sunvo vs Chemo

WU-KONG28 Study Design

Key Eligibility

Locally advanced or metastatic non-squamous NSCLC
Documented EGFR exon20ins
Newly diagnosed or treatment-naïve
ECOG PS 0 or 1

Randomization

Ratio1:1

StratificationBaseline brain metastasis (yes / no)

Sites154 sites · 15 countries

Data cutoffJanuary 16, 2026

Sunvozertinib (N=163)

300 mg once daily, oral
Continuous until progression or unacceptable toxicity

Platinum-based Chemotherapy (N=161)

Carboplatin AUC5 + pemetrexed 500 mg/m² Q3W
Up to 4 or 6 cycles (investigator discretion) → pemetrexed maintenance
Crossover to sunvozertinib allowed at confirmed PD

Endpoints

Primary PFS assessed by BICR Key Secondary Overall Survival (OS) Secondary Investigator-assessed PFS · ORR · DCR · DoR · Tumor size change · Safety · PK Exploratory PFS2

Efficacy

Primary Endpoint: Median PFS (BICR)

Sunvozertinib10.3 mo

95% CI: 8.3, 14.0

Chemotherapy7.5 mo

95% CI: 6.7, 8.5

HR (95% CI)0.65 (0.50, 0.85)

P value<0.001

PFS Landmark Rates

12 months46.1% vs 26.7%

18 months33.2% vs 17.1%

24 months23.0% vs 10.3%

Median follow-up: 24.0 mo (sunvo) · 18.0 mo (chemo)

Objective Response Rate (BICR)

Confirmed ORR

Sunvozertinib58.9%

95% CI: 50.9, 66.5

Chemotherapy31.1%

95% CI: 24.0, 38.8

Odds Ratio (95% CI)3.2 (2.0, 5.0)

Additional Response Data (from ASCO presentation)

Best ORR68.1% vs 35.4%

Disease Control Rate94.5% vs 85.7%

Duration of Response

Sunvozertinib11.2 mo

95% CI: 8.2, 13.9

Chemotherapy7.1 mo

95% CI: 6.9, 11.1

Median follow-up: 22.1 mo (sunvo) · 13.8 mo (chemo)

Median Tumor Size Shrinkage

Sunvozertinib-42.1%

Range: -88.6 to 21.3

Chemotherapy-24.7%

Range: -85.6 to 362.2

Crossover

101 of 112 chemotherapy-arm patients (90.2%) with confirmed disease progression crossed over to receive sunvozertinib.

Interim Overall Survival

Sunvozertinib29.8 mo

95% CI: 21.8, NE

Chemotherapy28.8 mo

95% CI: 20.7, NE

HR (95% CI)0.99 (0.70, 1.40)

P value0.48

Data maturity38.9% (126/324 events)

OS Landmark Rates

18 months65.5% vs 67.2%

24 months57.4% vs 56.2%

30 months50.0% vs 49.1%

Median OS follow-up: 26.1 mo (sunvo) · 26.7 mo (chemo). OS data immature; interpretation may be confounded by the crossover design. NE, not estimable.

Subgroup Analysis: BICR-assessed PFS

← Favors sunvozertinib HR = 1.0 Favors chemotherapy →

Overall(n=324)

0.65 (0.50, 0.85)

Age Group

<65 years(n=182)

0.62 (0.44, 0.87)

≥65 years(n=142)

0.71 (0.46, 1.07)

Sex

Female(n=192)

0.68 (0.48, 0.97)

Male(n=132)

0.58 (0.39, 0.85)

Race

Asian(n=204)

0.56 (0.41, 0.77)

Non-Asian(n=120)

0.93 (0.58, 1.48)

Region

North America + EU(n=102)

0.78 (0.47, 1.30)

Others(n=222)

0.62 (0.45, 0.84)

Smoking History

Never(n=208)

0.61 (0.43, 0.85)

Ever(n=116)

0.73 (0.48, 1.11)

Baseline ECOG

0(n=89)

0.77 (0.45, 1.31)

≥1(n=235)

0.62 (0.46, 0.84)

Brain Metastasis at Baseline

With(n=41)

0.96 (0.44, 2.08)

Without(n=283)

0.62 (0.47, 0.83)

EGFR Exon20ins Subtype

769_ASV(n=103)

0.46 (0.29, 0.73)

770_SVD(n=53)

Other/Unknown(n=168)

0.77 (0.53, 1.10)

EGFR Exon20ins Region

Near loop(n=220)

0.59 (0.43, 0.82)

Far loop(n=84)

0.83 (0.49, 1.38)

C-helix/Unknown(n=20)

Disease-Related Surgery

With(n=65)

0.55 (0.29, 1.02)

Without(n=259)

0.69 (0.51, 0.92)

X-axis range: 0.2 to 2.5. NR = not reported (insufficient events). Source: Heymach et al, ASCO 2026 LBA8500 (slide 7).

Safety

Sunvozertinib N=163; Chemotherapy N=150 (patients who received randomized treatment)

Safety Overview

Parameter	Sunvozertinib %	Chemotherapy %
Any adverse event	100.0	99.3
Any AE, Grade ≥3	75.5	56.7
Any TRAE	100.0	97.3
Any TRAE, Grade ≥3	61.3	49.3
Treatment-related SAE	18.4	12.7
TRAE leading to dose interruption	45.4	27.3
TRAE leading to dose reduction	40.5	24.0
TRAE leading to discontinuation	7.4	11.3
TRAE with fatal outcome	0.0	0.7

Top TRAEs leading to dose interruption and reduction with sunvozertinib: CPK increased and diarrhea (neither led to treatment discontinuation).

Adverse Events ≥20% in Either Group (Any Grade)

All-cause adverse events emerging during treatment (per NEJM Table 3). Grade ≥3 shown in adjacent column.

Sunvo

G≥3

Chemo

G≥3

Diarrhea

87.1%

14.1%

16.7%

—

CPK increased

58.3%

20.9%

4.0%

0.7%

Anemia

57.1%

9.2%

62.7%

11.3%

Rash

52.8%

0.6%

6.7%

—

Paronychia

48.5%

3.7%

0.7%

—

Weight decreased

43.6%

3.7%

11.3%

0.7%

Decreased appetite

38.7%

1.8%

28.0%

1.3%

Creatinine increased

33.7%

0.6%

9.3%

—

Nausea

28.2%

1.8%

46.0%

1.3%

Vomiting

28.2%

1.8%

24.0%

2.0%

Hypokalemia

25.2%

3.7%

7.3%

0.7%

Amylase increased

23.3%

1.2%

11.3%

—

Lipase increased

23.3%

5.5%

7.3%

1.3%

AST increased

22.1%

2.5%

37.3%

0.7%

Mouth ulceration

20.2%

1.2%

3.3%

—

ALT increased

17.8%

1.8%

34.7%

1.3%

Fatigue

15.3%

1.2%

20.0%

2.7%

Neutrophil ↓

14.7%

2.5%

45.3%

18.7%

WBC ↓

12.3%

0.6%

39.3%

6.7%

Constipation

11.0%

0.6%

25.3%

—

Platelet ↓

9.2%

2.5%

22.0%

6.7%

Sunvozertinib AEs reflect wild-type EGFR inhibition (diarrhea, rash, paronychia, CPK elevation). Chemotherapy-associated myelosuppression (anemia, neutropenia, thrombocytopenia) predominates in the chemo arm.

References

Heymach JV, Liu G, Xing L, et al. Sunvozertinib monotherapy versus platinum-based chemotherapy as first-line treatment for advanced NSCLC with EGFR exon20ins: primary analysis of a multinational phase 3 randomized study (WU-KONG28). J Clin Oncol. 2026;44(suppl 17):LBA8500. doi:10.1200/JCO.2026.44.17_suppl.LBA8500. Presented at: 2026 ASCO Annual Meeting; May 29–June 2, 2026; Chicago, IL.
Zhou C, Greillier L, Liu G, et al. First-line sunvozertinib in NSCLC with EGFR exon 20 insertion mutations. N Engl J Med. 2026. doi:10.1056/NEJMoa2604461.
ClinicalTrials.gov identifier: NCT05668988.

Abbreviations

BICRBlinded Independent Central Review

cORRConfirmed Objective Response Rate

CPKCreatine phosphokinase

DCRDisease Control Rate

DoRDuration of Response

ECOGEastern Cooperative Oncology Group

EGFREpidermal Growth Factor Receptor

Exon20insExon 20 Insertion Mutations

HRHazard Ratio

mPFSMedian Progression-Free Survival

NSCLCNon-Small Cell Lung Cancer

ORRObjective Response Rate

OSOverall Survival

PFSProgression-Free Survival

PFS2Second Progression-Free Survival

Q3WEvery 3 Weeks

SAESerious Adverse Event

TKITyrosine Kinase Inhibitor

TRAETreatment-Related Adverse Event

May 30, 2026