Drug Trials Snapshots: ZEGFROVY
HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
LIMITATIONS OF THIS SNAPSHOT
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.
Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the ZEGFROVY Prescribing Information for all the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).
Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).
ZEGFROVY (sunvozertinib) tablets, for oral use
zeg-FROH’-vee
Dizal (Jiangsu) Pharmaceutical Co., Ltd.
Approval date: July 2, 2025
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
ZEGFROVY is a kinase inhibitor and is available by prescription.
ZEGFROVY is used as a single agent for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, whose disease has progressed on or after a platinum-based chemotherapy.
How is this drug used?
ZEGFROVY is a tablet taken with food by mouth once daily.
Who participated in the clinical trials?
The FDA approved ZEGFROVY based on evidence from one clinical trial (WU-KONG1B / NCT03974022) in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on platinum-based chemotherapy and received ZEGFROVY 200 mg once daily with food. WU-KONG1B enrolled 202 patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations who had received previous platinum-based chemotherapy. The trial was conducted at 89 sites the United States, Argentina, Australia, Canada, China, Chile, France, Italy, Malaysia, South Korean, Spain, and Taiwan.
The number of patients representing the efficacy findings differs from the number of patients representing safety due to different pools of study participants analyzed for efficacy and safety.
How were the trials designed?
WU-KONG1B was a multinational, open-label, dose randomization trial in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations with disease progression on or after platinum-based chemotherapy.
Patients were randomized (1:1) to either receive ZEGROVY 200 mg orally once daily with food or ZEGFROVY at an unapproved dose once daily with food. Patients were treated with ZEGFROVY until disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or unacceptable toxicity.
Randomization was stratified by prior therapies (<3 versus 3) and baseline brain metastasis (yes versus no). Tumor assessments were conducted every six weeks.
The major efficacy outcome measure was confirmed blinded independent review committee (BIRC) assessed overall response rate (ORR) according to RECIST v1.1. Additional efficacy outcome measure was BIRC-assessed duration of response (DOR).
A total of 192 patients were enrolled and randomized to ZEGFROVY 200 mg (n=85) or ZEGFROVY at an unapproved dose (n=89). An additional 18 patients were not randomized and received ZEGFROVY at an unapproved dose (N=107 total patients received ZEGFROVY at an unapproved dose). The efficacy population characteristics were: median age of 61 years (range: 35 to 88); 43% age 65 or older; 67% female; 65% Asian, 33% White; and 61% with Eastern Cooperative Oncology Group (ECOG) performance status of 1. A total of 96% of patients had metastatic disease at study entry and 94% had adenocarcinoma histology.
All 85 patients in the efficacy population had EGFR exon 20 insertion mutations in tumor based prospective local or central laboratory testing. The ORR was 46% (95% CI: 35, 57) and DOR was 11.1 months (95% CI: 8.2, not evaluable).
DEMOGRAPHICS SNAPSHOT
Figure 1 summarizes how many male and female patients were enrolled in the clinical trial used to evaluate the efficacy of ZEGFROVY.
Figure 1. Baseline Demographics by Sex, Efficacy Population
Source: Adapted from FDA Multidisciplinary Review
Figure 2 summarizes how many patients by sex were enrolled in the clinical trial used to evaluate the side effects of ZEGFROVY.
Figure 2. Baseline Demographics by Sex, Safety Population
Source: Adapted from Multidisciplinary Review
Figure 3 summarizes how many patients by race were enrolled in the clinical trial used to evaluate the efficacy of ZEGFROVY.
Figure 3. Baseline Demographics by Race, Efficacy Population
Source: Adapted from Multidisciplinary Review
Figure 4 summarizes how many patients by race were enrolled in the clinical trial used to evaluate the side effects of ZEGFROVY.
Figure 4. Baseline Demographics by Race, Safety Population
Source: Adapted from FDA Multidisciplinary Review
Figure 5 summarizes how many patients by age were enrolled in the clinical trial used to evaluate the efficacy of ZEGFROVY.
Figure 5. Baseline Demographics by Age, Efficacy Population
Source: Adapted from FDA Multidisciplinary Review
Figure 6 summarizes how many patients by age were enrolled in the clinical trial used to evaluate the side effects of ZEGFROVY.
Figure 6. Baseline Demographics by Age, Safety Population
Source: Adapted from FDA Multidisciplinary Review
Figure 7 how many patients by ethnicity were enrolled in the clinical trial used to evaluate the efficacy of ZEGFROVY.
Figure 7. Baseline Demographics by Ethnicity, Efficacy Population
Source: Adapted from FDA Multidisciplinary Review
Figure 8 summarizes how many patients by ethnicity were enrolled in the clinical trial used to evaluate the side effects of ZEGFROVY.
Figure 8. Baseline Demographics by Ethnicity, Safety Population
Source: Adapted from FDA Multidisciplinary Review
Who participated in the trials?
Table 1. Baseline Demographics of Patients in the Clinical Trial, Efficacy and Safety Populations
Demographic variable |
Efficacy Population N=85 |
Safety Population N=91 |
|---|---|---|
Sex, n (%) |
|
|
Male |
28 (33) |
30 (33) |
Female |
57 (67) |
61 (67) |
Race, n (%) |
|
|
Asian |
55 (65) |
59 (65) |
White |
28 (33) |
30 (33) |
Unknown or Not reported |
2 (2.4) |
2 (2.2) |
Age (years) |
|
|
Median |
61 |
62 |
Minimum, maximum |
35, 88 |
35, 88 |
Age category, years, n (%) |
|
|
<65 |
46 (54) |
48 (53) |
≥65 to <75 |
29 (34) |
33 (36) |
≥75 |
10 (12) |
10 (11) |
Ethnicity, n (%) |
|
|
Hispanic or Latino |
2 (2.4) |
3 (3.3) |
Not Hispanic or Latino |
83 (98) |
88 (97) |
Source: Adapted from FDA Multidisciplinary Review
What are the benefits of this drug?
ZEGFROVY was approved under FDA’s accelerated approval program, which provides earlier patient access to a promising new drug while the company continues to conduct clinical trial(s) to confirm that the drug works well.
In WU-KONG1B, 46% of patients with EGFR exon 20 insertion mutations treated with ZEGFROVY in the clinical study experienced complete or partial shrinkage of their tumors. Shrinkage lasted at least six months for 72% of these patients.
What are the benefits of this drug (results of trials used to assess efficacy)?
Table 2 shows the efficacy results in LUMINOSITY for patients with EGFR wild-type non-squamous NSCLC with high c-Met protein overexpression.
Table 2. Efficacy Results
Efficacy Parameter |
ZEGFROVY N=85 |
|---|---|
Overall response rate, % (95% CI) |
46 (35, 57) |
Complete response, % |
6 |
Partial response, % |
40 |
Duration of response |
N=39 |
Median, months (95% CI) |
11.1 (8.2, NE) |
Patients with DOR ≥6 months, % |
72 |
Source: ZEGFROVY Prescribing Information
95% CI for ORR was calculated based on Clopper-Pearson exact CI method
Abbreviations: CI, confidence interval; DOR, duration of response; NE, not estimable; ORR, overall response rate
Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?
- Sex: ZEGFROVY worked similarly in males and females.
- Race: The observed effect of ZEGFROVY was larger for Asian than White patients. Because of limited data, this difference may be due to chance.
- Age: The observed effect of ZEGFROVY was larger for patients 65 years of age and older than younger patients. Because of limited data, this difference may be due to chance.
Were there any differences in how well the drug worked in clinical trials among sex, race, and age
Table 3 summarizes efficacy results by sex, race, and age group based on the overall response rate.
Table 3. Efficacy Results by Sex, Race, and Age, Efficacy Population
Demographic Subgroup |
N |
ORR % (95% CI) |
|---|---|---|
Overall |
85 |
46 (35, 57) |
Sex |
|
|
Male |
28 |
43 (24, 63) |
Female |
57 |
47 (34, 61) |
Age, years |
|
|
<65 |
46 |
39 (25, 55) |
≥65 |
39 |
54 (37, 70) |
Race |
|
|
Asian |
55 |
53 (39, 66) |
White or Unknown |
30 |
33 (17, 53) |
Source: Adapted from FDA Multidisciplinary Review
Abbreviations: CI, confidence interval; ORR, overall response rate
What are the possible side effects?
ZEGFROVY may cause serious and potentially deadly side effects, including inflammation of the lungs (pneumonitis), stomach and intestinal (gastrointestinal) problems, skin problems, eye problems, and harm to an unborn baby.
The most common side effects of ZEGFROVY are diarrhea, rash, decreased appetite, mouth sores, feeling very tired, nausea, infected skin around the nail, vomiting, constipation, muscle or joint pain, itchy skin, dry skin, urinary tract infection, stomach-area pain, and decreased weight.
What are the possible side effects (results of trials used to assess safety)?
Table 4. Adverse Reactions (≥10%) in Patients Who Received ZEGFROVY, Safety Population
|
ZEGFROVY, N=91 |
|
|---|---|---|
Adverse Reaction |
All Grades % |
Grade 3 or 4 % |
Gastrointestinal disorders |
|
|
Diarrhea1 |
73 |
2.2 |
Stomatitis1 |
40 |
2.2 |
Vomiting1 |
35 |
0 |
Nausea |
32 |
2.2 |
Constipation |
27 |
0 |
Weight decreased |
26 |
3.3 |
Abdominal pain1 |
19 |
1.1 |
Abdominal distension |
16 |
0 |
Skin and subcutaneous tissue disorders |
|
|
Rash1 |
60 |
8 |
Paronychia1 |
30 |
0 |
Pruritus |
26 |
1.1 |
Dry skin1 |
21 |
0 |
Metabolism and nutrition disorders |
|
|
Decreased appetite |
52 |
0 |
General disorders and administration site conditions |
|
|
Fatigue1 |
41 |
1.1 |
Edema1 |
11 |
0 |
Malaise |
11 |
1.1 |
Musculoskeletal and connective tissue disorders |
|
|
Musculoskeletal pain1 |
26 |
2.2 |
Infections and infestations |
|
|
Pneumonia1 |
25 |
11 |
Urinary tract infection1 |
24 |
1.1 |
Eye disorders |
|
|
Ocular toxicity1 |
18 |
0 |
Nervous system disorders |
|
|
Peripheral neuropathy1 |
14 |
0 |
Cardiac disorders |
|
|
Arrhythmia1 |
12 |
1.1 |
Source: ZEGFROVY Prescribing Information
1 Grouped terms
Were there any differences in side effects among sex, race and age?
- Sex: The occurrence of side effects was similar in males and females.
- Race: The occurrence of side effects was similar in Asian and White patients, except that occurrence of Grade ≥3 treatment-emergent adverse events was higher in patients of White or other races. Because of limited data, this difference may be due to chance.
- Age: The occurrence of side effects was similar in patients younger and older than 65 years of age.
Were there any differences in side effects of the clinical trials among sex, race, and age groups?
Table 5. Subgroup Analysis of Adverse Events by Sex, Safety Population
Adverse Event |
Male N=30 n (%) |
Female N=61 n (%) |
|---|---|---|
Patients with TEAEs |
30 (100) |
61 (100) |
Patients with grade ≥3 TEAEs |
19 (63) |
37 (61) |
Patients with serious TEAEs |
14 (47) |
23 (38) |
Source: Adapted from FDA Multidisciplinary Review
Abbreviations: TEAE, treatment-emergent adverse event
Table 6. Subgroup Analysis of Adverse Events by Race, Safety Population
Adverse Event |
Asian N=59 n (%) |
White or Unknown N=32 n (%) |
|---|---|---|
Patients with TEAEs |
59 (100) |
32 (100) |
Patients with grade ≥3 TEAEs |
32 (54) |
24 (75) |
Patients with serious TEAEs |
23 (39) |
14 (44) |
Source: Adapted from FDA Multidisciplinary Review
Abbreviations: TEAE, treatment-emergent adverse event
Table 7. Subgroup Analysis of Adverse Events by Age, Safety Population
Adverse Event |
<65 Years N=48 n (%) |
≥65 Years N=43 n (%) |
|---|---|---|
Patients with TEAEs |
48 (100) |
43 (100) |
Patients with grade ≥3 TEAEs |
28 (58) |
28 (65) |
Patients with serious TEAEs |
17 (35) |
20 (47) |
Source: Adapted from FDA Multidisciplinary Review
Abbreviations: TEAE, treatment-emergent adverse event
GLOSSARY
CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effectsof the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.
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