Proven to reduce duration of severe neutropenia1-3
Demonstrated noninferiority vs pegfilgrastim1-3
Primary endpointMean Duration of Severe Neutropenia (Days) in Cycle 11-3
Selected Safety Information
Adverse Reactions
- Permanent discontinuation due to an adverse reaction occurred in 4% of patients who received ROLVEDON. The adverse reaction requiring permanent discontinuation in 3 patients who received ROLVEDON was rash.
Every day you help a cancer patient avoid severe neutropenia is critical4
Incidence and duration of Severe Neutropenia (DSN) by Day in Cycle 11-3
~84% of ROLVEDON patients had no severe neutropenia (compared to ~76% of pegfilgrastim patients)1,2
~80% of ROLVEDON patients had no severe neutropenia (compared to ~77% of pegfilgrastim patients)2,3
- Comparisons were conducted on patients with no SN and on individual days. The data do not support any day-to-day comparison advantages
- Demonstrated noninferiority vs pegfilgrastim1-3
Selected Safety Information
Adverse Reactions
- The most common adverse reactions (≥20%) were fatigue, nausea, diarrhea, bone pain, headache, pyrexia, anemia, rash, myalgia, arthralgia, and back pain.
The first long-acting myeloid growth factor in over 20 years with a unique molecular structure
ANC profile vs pegfilgrastim
Secondary endpointTime to ANC Recovery (Mean [SD] Days) in Cycle 1*
Study 11,5 | Study 23,5 | ||
---|---|---|---|
Eflapegrastim-xnst (n=196) | Pegfilgrastim (n=210) | Eflapegrastim-xnst (n=118) | Pegfilgrastim (n=119) |
3.24 (3.565) | 3.49 (3.589) | 3.49 (3.723) | 3.35 (3.745) |
Depth of ANC Nadir (Mean [SD] ANC x 109/L) in Cycle 1*
Study 15 | Study 25 | ||
---|---|---|---|
Eflapegrastim-xnst (n=196) | Pegfilgrastim (n=210) | Eflapegrastim-xnst (n=118) | Pegfilgrastim (n=119) |
2.56 (3.086) | 2.53 (3.317) | 2.67 (3.504) | 2.06 (2.034) |
SD=standard deviation.
- Time to ANC recovery and depth of ANC nadir were secondary endpoints. The differences did not meet threshold to support statistical significance.
Secondary endpointTime to ANC Recovery (Mean [SD] Days) in Cycle 1*
Study 11,5 | |
---|---|
Eflapegrastim‑xnst (n=196) | Pegfilgrastim (n=210) |
3.24 (3.565) | 3.49 (3.589) |
Study 23,5 | |
---|---|
Eflapegrastim‑xnst (n=118) | Pegfilgrastim (n=119) |
3.49 (3.723) | 3.35 (3.745) |
Depth of ANC Nadir (Mean [SD] ANC x 109/L) in Cycle 1*
Study 15 | |
---|---|
Eflapegrastim‑xnst (n=196) | Pegfilgrastim (n=210) |
2.56 (3.086) | 2.53 (3.317) |
Study 25 | |
---|---|
Eflapegrastim‑xnst (n=118) | Pegfilgrastim (n=119) |
2.67 (3.504) | 2.06 (2.034) |
SD=standard deviation.
- Time to ANC recovery and depth of ANC nadir were secondary endpoints. The differences did not meet threshold to support statistical significance.
Mean ANC Over Time in Cycle 11,3
- All data supporting endpoints were contained within days 5 through 8
Selected Safety Information
Leukocytosis
- White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving rhG-CSF products. Monitor complete blood count (CBC) during ROLVEDON therapy. Discontinue ROLVEDON treatment if WBC count of 100 x 109/L or greater occurs.
Secondary endpointIncidence of febrile neutropenia in cycle 11,3
From a total of 643 patients in both studies, febrile neutropenia was observed in 11 patients in cycle 1.3
- The incidence of febrile neutropenia in cycle 1 was a secondary endpoint, the data were insufficient to support statistical analysis.
Selected Safety Information
Sickle Cell Crisis in Patients with Sickle Cell Disorders
- Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving rhG-CSF products, such as ROLVEDON. Discontinue ROLVEDON if sickle cell crisis occurs.
Efficacy across 4 cycles of chemotherapy1,3,5
Additional secondary endpointMean DSN (Days) in Cycles 2 to 41,3,5
Selected Safety Information
Splenic Rupture
- Splenic rupture, including fatal cases, can occur following the administration of recombinant human granulocyte colony-stimulating factor (rhG-CSF) products. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
Proven safety profile5
Table 1. Common Adverse Reactions with a Frequency of ≥10% Through Week 14 in Patients with Early-Stage Breast Cancer in Study 1 and Study 2
Adverse Reaction | ROLVEDON (n=314)% | Pegfilgrastim** (n=326)% |
---|---|---|
Fatigue* | 181 (58%) | 192 (59%) |
Nausea | 162 (52%) | 166 (51%) |
Diarrhea | 125 (40%) | 126 (39%) |
Bone pain | 119 (38%) | 121 (37%) |
Headache* | 92 (29%) | 90 (28%) |
Pyrexia* | 87 (28%) | 84 (26%) |
Anemia* | 77 (25%) | 52 (16%) |
Rash* | 77 (25%) | 99 (30%) |
Myalgia | 69 (22%) | 49 (15%) |
Arthralgia | 66 (21%) | 48 (15%) |
Back pain* | 63 (20%) | 55 (17%) |
Decreased appetite | 61 (19%) | 50 (15%) |
Peripheral edema* | 57 (18%) | 53 (16%) |
Abdominal pain* | 53 (17%) | 67 (21%) |
Dizziness* | 50 (16%) | 38 (12%) |
Dyspnea* | 49 (16%) | 44 (13%) |
Cough* | 48 (15%) | 51 (16%) |
Thrombocytopenia* | 44 (14%) | 17 (5%) |
Pain | 37 (12%) | 42 (13%) |
Pain in extremity | 36 (11%) | 42 (13%) |
Local administration reactions* | 34 (11%) | 27 (8%) |
Flushing | 32 (10%) | 27 (8%) |
*Grouped Terms
**Study 1 and Study 2 were not designed to evaluate meaningful comparisons of the incidence of adverse reactions in the ROLVEDON and the pegfilgrastim treatment groups.
References:
- Schwartzberg LS, Bhat G, Peguero J, et al. Eflapegrastim, a long-acting granulocyte-colony stimulating factor for the management of chemotherapy-induced neutropenia: results of a phase III trial. Oncologist. 2020;25(8):e1233-e1241.
- ROLVEDON [package insert]. Irvine, CA: Spectrum Pharmaceuticals, Inc.
- Cobb PW, Moon YW, Mezei K, et al. A comparison of eflapegrastim to pegfilgrastim in the management of chemotherapy-induced neutropenia in patients with early-stage breast cancer undergoing cytotoxic chemotherapy (RECOVER): a phase 3 study. Cancer Med. 2020;9(17):6234–6243.
- Li Y, Klippel Z, Shih X, Reiner M, Wang H, Page JH. Relationship between severity and duration of chemotherapy-induced neutropenia and risk of infection among patients with nonmyeloid malignancies. Support Care Cancer.2016;24(10):4377-4383.
- Data on file. Spectrum Pharmaceuticals, Inc.
The first long-acting myeloid growth factor in over 20 years with a unique molecular structure