(lazertinib)
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Last Updated: 11/07/2024
AEs, n (%) | RYBREVANT + Lazertinib (n=421) | Osimertinib (n=428) | ||
---|---|---|---|---|
All Grades | Grade ≥3 | All Grades | Grade ≥3 | |
Paronychia | 288 (68) | 46 (11) | 121 (28) | 2 (<1) |
Treatment-related paronychia | 285 (68) | 44 (10) | 115 (27) | 2 (<1) |
Paronychia leading to: | ||||
Interruption of any study drug in ≥3% of patients in any group | 91 (22) | 4 (1) | ||
Reduction of any study drug in ≥1% of patients in any group | 80 (19) | 1 (<1) | ||
Discontinuation of any study drug in ≥1% of patients in any group | 14 (3) | 0 | ||
Abbreviation: AE, adverse event. a |
Guidelines for prevention and management of paronychia throughout treatment were reported and are summarized below.
AEs, n (%) | RYBREVANT + Chemotherapy (n=151) | Chemotherapy (n=155) | ||
---|---|---|---|---|
All Grades | Grade ≥3 | All Grades | Grade ≥3 | |
Paronychia | 85 (56) | 10 (7) | 0 | 0 |
Abbreviation: AE, adverse event. aThe safety population included all randomized patients who received ≥1 dose of any study treatment. |
Guidelines for prevention and management of paronychia throughout treatment were reported and are summarized below.
TEAEs, n (%) | RYBREVANT-Lazertinib-Chemotherapy (n=263) | RYBREVANT-Chemotherapy (n=130) | Chemotherapy (n=243) | |||
---|---|---|---|---|---|---|
All Grades | Grade ≥3 | All Grades | Grade ≥3 | All Grades | Grade ≥3 | |
Paronychia | 133 (51) | 11 (4) | 48 (37) | 1 (0.4) | 0 | |
Abbreviation: TEAE, treatment-emergent adverse event. |
Guidelines for prevention and management of paronychia throughout treatment were reported and are summarized below.
The results of the CHRYSALIS study are also included in the RYBREVANT product labeling. The incidence of adverse reactions described below may vary from that in the RYBREVANT product labeling due to the evaluation of different patient populations for safety analyses, contributing to differences in reported percentages. The summary below describes safety results from patients with metastatic or unresectable NSCLC and EGFR Exon20ins mutations with disease progression during or after platinum-based chemotherapy who received RYBREVANT at the RP2D and all patients treated at the RP2D.
AEs, n (%) | Safety Population (n=114)a | All Patients Treated at the RP2D (n=258)b | ||
---|---|---|---|---|
Total | Grade ≥3 | Total | Grade ≥3 | |
Paronychia | 51 (45) | 1 (1) | 104 (40) | 3 (1) |
08 June 2020 safety data cutoff. Abbreviations: AE, adverse event; EGFR, epidermal growth factor receptor; Exon20ins, exon 20 insertion; RP2D, recommended phase 2 dose. aIncluded patients with EGFR Exon20ins mutation who progressed on platinum-based chemotherapy and were treated at the RP2D. bIncluded all patients treated at the RP2D across the dose escalation phase and dose expansion phase. |
AEs, n (%) | Safety Population (n=114) | All Patients Treated at the RP2D (n=474) | ||
---|---|---|---|---|
Total | Grade ≥3 | Total | Grade ≥3 | |
Paronychia | 66 (58) | 4 (4) | 204 (43) | 9 (2) |
12 September 2022 safety data cutoff. Abbreviations: AE, adverse event; RP2D, recommended phase 2 dose. |
Guidelines for management of paronychia throughout treatment were reported and are summarized below.
Singh-Kandah et al (2024)11 reported results from a post hoc analysis of the CHRYSALIS study on the incidence, severity, time to first onset, and management of rash and paronychia in patients treated with RYBREVANT at the RP2D (N=380).
TEAEs, n (%) | Grade | Overall | Median Time to First Occurrence, Days | ||
---|---|---|---|---|---|
1 | 2 | 3 | |||
Paronychia | 72 (19) | 85 (22) | 69 | ||
March 2021 data cutoff. Abbreviations: RP2D, recommended phase 2 dose; TEAE, treatment-emergent adverse event. |
Medication Type, n (%) | Rash (n=288) | Paronychia (n=164) |
---|---|---|
Any | 255 (89) | 125 (76) |
Systemic antibiotics | 187 (65) | 58 (35) |
Systemic corticosteroids | 132 (46) | 24 (15) |
Topical corticosteroids | 119 (41) | 40 (24) |
Systemic antihistamines | 40 (14) | 1 (1) |
Topical antibiotics | 38 (13) | 57 (35) |
Emollients and protectives | 23 (8) | 5 (3) |
Topical antifungals | 23 (8) | 2 (1) |
Antiacne preparations | 17 (6) | 4 (2) |
Other dermatologic preparations | 16 (6) | 6 (4) |
Ophthalmologic medications | 13 (5) | 23 (14) |
Antiseptics and disinfectants | 12 (4) | 12 (7) |
aGreater than 5% in 1 group or more. Note: Examples of systemic antibiotics are doxycycline, minocycline, and cephalexin. Examples of systemic corticosteroids are prednisone, prednisolone, and methylprednisolone. Examples of topical corticosteroids are betamethasone, hydrocortisone, clobetasol, and prednicarbate. Examples of systemic antihistamines are fexofenadine, ebastine, diphenhydramine, and bepotastine. Examples of topical antibiotics are clindamycin, mupirocin, erythromycin, and terramycin. Examples of emollients and protectives are emollient creams, white soft paraffin, and petrolatum. Examples of topical antifungals are ciclopirox olamine, ketoconazole, metronidazole, and terbinafine. Examples of antiacne preparations are isotretinoin, benzoyl peroxide/clindamycin, and nadifloxacin. An example of other dermatologic preparations is pyrithione zinc. Examples of antiseptics and disinfectants are silver nitrate and lactic acid lotion. |
The information provided in this section summarizes interventions investigators in the phase 3 studies were instructed to perform to manage paronychia.12-14 These are not recommendations for individual patient care. Interventions should be based on patient presentation and the clinical judgment of the treating physician.
In addition to the guidance for grade 1 paronychia above:
The information provided in this section summarizes interventions investigators in the CHRYSALIS study were instructed to perform to manage paronychia.15 These are not recommendations for individual patient care. Interventions should be based on patient presentation and the clinical judgment of the treating physician.
The information provided in this section includes best practices for prevention and management of paronychia reported in the literature.16 These are not recommendations for individual patient care. Interventions should be based on patient presentation and the clinical judgment of the treating physician.
Prevention | Treatment |
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Medications:
Other interventions:
| Medications:
Other interventions:
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1 | Moores SL, Chiu ML, Bushey BS, et al. A novel bispecific antibody targeting EGFR and cMet is effective against EGFR inhibitor-resistant lung tumors. Cancer Res. 2016;76(13):3942-3953. |
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