On March 7, 2019 Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, reported that three COPIKTRA (duvelisib) abstracts were presented at the 23rd Annual International Congress on Hematologic Malignancies (ICHM), which took place February 28 – March 3, 2019, in Miami, FL (Press release, Verastem, MAR 7, 2019, View Source [SID1234534087]). The abstracts describe duvelisib data, including long-term (>2 years) efficacy and safety, the Phase 3 DUO crossover extension study in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and prognostic and immune-related factors associated with response to duvelisib from the Phase 2 DYNAMO study in indolent non-Hodgkin’s lymphoma (iNHL). COPIKTRA, an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, received approval from the U.S. Food and Drug Administration (FDA) in September 2018 for the treatment of patients with relapsed or refractory CLL/SLL after at least two prior therapies.
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COPIKTRA also received accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Accelerated approval was based on overall response rate and continued approval for this indication may be contingent upon confirmatory trials.
"The subset of 46 patients who received duvelisib monotherapy for greater than 2 years achieved an overall response rate (ORR) of 89% and a median progression-free survival (PFS) of 40 months," commented Ian Flinn, MD, PhD, Director, Lymphoma/CLL Program at Sarah Cannon Research Institute and lead author of the abstract. "In this study, we were able to manage most adverse events through dose reductions and dosing holds, which allowed these patients to remain on treatment. These data support duvelisib’s potential as a long-term treatment in patients with relapsed or refractory CLL/SLL and we are excited to share them with the medical community at ICHM 2019."
Long-Term Efficacy and Safety of Duvelisib Monotherapy in Patients with CLL/SLL on Treatment for More Than 2 Years Across 4 Clinical Studies
This presentation, authored by Dr. Flinn, describes a pooled efficacy and safety analysis from four clinical studies in patients with relapsed or refractory CLL/SLL in the subset of patients who received duvelisib monotherapy (25mg twice daily) for greater than 2 years. Responses were determined by investigators using modified IWCLL/IWG criteria. Among the 46 evaluable patients (median two prior therapies), duvelisib monotherapy achieved a 89% ORR, including 20% complete response or complete response with incomplete blood count recovery (CR/CRi) and 70% partial response (PR). Median PFS was 40 months. Among the 10 patients with 17p deletion/TP53 mutation, duvelisib monotherapy achieved a 100% ORR (30% CR/CRi and 70% PR) with a median PFS of 38 months. The most common adverse events (AEs) of any grade in patients treated with duvelisib for greater than 2 years were infections, diarrhea, pneumonia and colitis and the most common Grade ≥3 AEs were infections, rash, colitis and pneumonia. In general, the AE profile for patients treated with duvelisib for greater than 2 years was similar to the profile in patients on treatment for less than two years. Dose reductions and dose holds were utilized to manage AEs and allow patients to continue deriving benefit from treatment. These data support duvelisib monotherapy as a long-term treatment option for patients with relapsed or refractory CLL/SLL with the potential for a durable response and tolerability to treatment.
Efficacy and Safety of Duvelisib Following Disease Progression on Ofatumumab in Patients with Relapsed/Refractory CLL or SLL: Updated Results from the DUO Crossover Extension Study
This presentation, authored by Matthew Davids, M.D., of the Dana-Farber Cancer Institute, describes data from the open-label, DUO crossover extension study where patients with confirmed progressive disease (PD) following treatment with ofatumumab in DUO were given the option to receive treatment with duvelisib. Response was determined by investigator assessment using modified IWCLL/IWG criteria. Among the 90 evaluable patients (median three prior therapies (range 2-8)) in the extension study, duvelisib monotherapy achieved a 77% ORR (95% CI: 68, 85), including 4% CRi and 62% PR. While on ofatumumab in the DUO study, these 90 patients had a 29% ORR (95% CI: 20, 38), including 1% CR and 28% PR. The median PFS for duvelisib-treated patients in the extension study was 15.2 months (95% CI: 12, 20). While on ofatumumab in the DUO study, these 90 patients had a median PFS of 9.4 months (95% CI: 9, 11), per investigator’s assessment. Duvelisib achieved a 63% ORR in patients (n=56) who had a best overall response (BOR) of stable disease (SD) on ofatumumab pre-crossover. The subset of patients with 17p deletion (n=20) achieved an 80% ORR. In patients who did not respond to ofatumumab pre-crossover (n=8), duvelisib achieved a 75% ORR. The median time to response was 2.6 months. Median exposure to duvelisib in the extension study was 9.8 months (max: 39 months), with a median total follow-up of 12.5 months. The most common treatment-emergent AEs of any grade occurring in ≥10% of patients were diarrhea, rash, neutropenia, pyrexia, pneumonia, colitis, cough, asthenia, vomiting, decreased appetite and nausea. The most common treatment-emergent Grade ≥3 AEs occurring in ≥10% of patients were neutropenia, diarrhea, pneumonia and colitis.
"In the DUO crossover extension study, duvelisib monotherapy achieved a 77% ORR, with a median PFS of 15 months in patients with relapsed or refractory CLL/SLL who had experienced disease progression following ofatumumab monotherapy pre-crossover," said Dr. Davids. "In the subset of patients with 17p deletion the ORR was 80%. These response rates are encouraging because they are comparable to those seen in earlier lines of treatment, despite being administered in this heavily pretreated patient population who have progressed following this additional line of treatment. The safety profile of duvelisib in this study was manageable and consistent with the known safety profile in CLL/SLL. Collectively, these data continue to support the clinical benefit of duvelisib monotherapy in patients with relapsed or refractory CLL/SLL."
Prognostic and Immune-Related Factors Associated with Response to Duvelisib in the Phase 2 DYNAMO Clinical Trial in Patients with Indolent Non-Hodgkin Lymphoma
The Phase 2 DYNAMO study (NCT01882803) evaluated duvelisib monotherapy in patients indolent non-Hodgkin’s lymphoma (iNHL) who were refractory to rituximab and to either chemotherapy or radioimmunotherapy. Refractory disease was defined as less than a partial remission or relapse within 6 months after the last dose. Among this patient population, the FL subgroup (n=83) had a median PFS of 8.3 months and an ORR of 42%. This presentation, authored by Pier Luigi Zinzani, M.D., PH.D., University of Bologna Institute of Hematology, describes an analysis of prognostic factors and indices (FLIPI and M7-FLIPI) that was undertaken to identify FL patient subgroups responsive to duvelisib. The analysis showed that median PFS and ORR were similar for duvelisib-treated FL patients regardless of poor prognostic indicators, including FLIPI, M7-FLIPI, and chromosome 6q deletions. Multivariate LASSO regressions with 84 variables revealed baseline characteristics including the number of prior therapies (1 versus 2 or more), as well as a biomarker profile of NK cellsL, IL17+ CD8 TL, and CCL19L that correlated with improved ORR. A biomarker profile of NK cellsL, IL17+ CD8 TL, CD3 TH, and CCL19L correlated with improved PFS. In the DYNAMO study, the most frequent treatment-emergent AEs of any grade were diarrhea, nausea, neutropenia, fatigue, and cough. Among the 88.4% of patients with at least one Grade ≥3 treatment-emergent AE, the most common treatment-emergent AEs were neutropenia, diarrhea, anemia, and thrombocytopenia. Patients experiencing AEs, including potentially immune-related events, demonstrated generally similar PFS to those patients who did not experience AEs, after adjusting for time.
"In the Phase 2 DYNAMO study, ORR and median PFS were similar for duvelisib-treated FL patients regardless of poor prognostic indicators, including FLIPI, M7-FLIPI and chromosome 6q deletions. Notably, certain baseline characteristics, including number of prior therapies and the presence of certain biomarkers correlated to ORR and median PFS. These data may be useful in identifying FL patients who would be responsive to treatment with duvelisib." said Dr. Zinzani.
PDF copies of all of these abstract presentations are available here.
COPIKTRA has a BOXED WARNING for four fatal and/or serious toxicities: infections, diarrhea or colitis, cutaneous reactions, and pneumonitis. Verastem Oncology has implemented a Risk Evaluation and Mitigation Strategy to provide appropriate dosing and safety information to better support physicians in managing their patients on COPIKTRA.
Additionally, COPIKTRA is also associated with adverse reactions which may require dose reduction, treatment delay or discontinuation of COPIKTRA. WARNINGS AND PRECAUTIONS are provided for infections, diarrhea or colitis, cutaneous reactions, pneumonitis, hepatotoxicity, neutropenia, and embryo-fetal toxicity. The most common ADVERSE REACTIONS (reported in ≥ 20% of patients) were diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.
Please see the Important Safety Information below and the full Prescribing Information, including BOXED WARNING, and patient Medication Guide found on www.COPIKTRA.com
COPIKTRA has been added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for CLL/SLL, FL and Marginal Zone Lymphoma (MZL). The NCCN Guidelines are the standard physician resource for determining the appropriate course of treatment for patients. COPIKTRA is not approved for use in MZL.
Verastem Oncology is committed to helping patients with CLL/SLL and FL access COPIKTRA through our Verastem Cares program. Verastem Cares is a comprehensive, personalized program designed to provide information and assistance to patients who have been prescribed COPIKTRA.
Patients, physicians, pharmacists, or other healthcare professionals with questions about COPIKTRA should contact 1-833-570-2273 (CARE) or visit www.COPIKTRA.com.
Important Safety Information
WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS
See full prescribing information for complete boxed warning
Fatal and/or serious infections occurred in 31% of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected.
Fatal and/or serious diarrhea or colitis occurred in 18% of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA.
Fatal and/or serious cutaneous reactions occurred in 5% of COPIKTRA-treated patients. Withhold COPIKTRA.
Fatal and/or serious pneumonitis occurred in 5% of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA.
WARNINGS AND PRECAUTIONS
Infections: Serious, including fatal (18/442; 4%), infections occurred in 31% of patients receiving COPIKTRA 25 mg BID (N=442). The most common serious infections were pneumonia, sepsis, and lower respiratory infections. Median time to onset of any grade infection was 3 months (range: 1 day to 32 months), with 75% of cases occurring within 6 months. Treat infections prior to initiation of COPIKTRA. Advise patients to report new or worsening signs and symptoms of infection. For grade 3 or higher infection, withhold COPIKTRA until infection has resolved. Resume COPIKTRA at the same or reduced dose.
Serious, including fatal, Pneumocystis jirovecii pneumonia (PJP) occurred in 1% of patients taking COPIKTRA. Provide prophylaxis for PJP during treatment with COPIKTRA and following completion of treatment with COPIKTRA until the absolute CD4+ T cell count is greater than 200 cells/μL. Withhold COPIKTRA in patients with suspected PJP of any grade, and permanently discontinue if PJP is confirmed.
Cytomegalovirus (CMV) reactivation/infection occurred in 1% of patients taking COPIKTRA. Consider prophylactic antivirals during COPIKTRA treatment to prevent CMV infection including CMV reactivation. For clinical CMV infection or viremia, withhold COPIKTRA until infection or viremia resolves. If COPIKTRA is resumed, administer the same or reduced dose and monitor patients for CMV reactivation by PCR or antigen test at least monthly.
Diarrhea or Colitis: Serious, including fatal (1/442; <1%), diarrhea or colitis occurred in 18% of patients receiving COPIKTRA 25 mg BID (N=442). Median time to onset of any grade diarrhea or colitis was 4 months (range: 1 day to 33 months), with 75% of cases occurring by 8 months. The median event duration was 0.5 months (range: 1 day to 29 months; 75th percentile: 1 month).
Advise patients to report any new or worsening diarrhea. For patients presenting with mild or moderate diarrhea (Grade 1-2) (i.e., up to 6 stools per day over baseline) or asymptomatic (Grade 1) colitis, initiate supportive care with antidiarrheal agents, continue COPIKTRA at the current dose, and monitor the patient at least weekly until the event resolves. If the diarrhea is unresponsive to antidiarrheal therapy, withhold COPIKTRA and initiate supportive therapy with enteric acting steroids (e.g., budesonide). Monitor the patient at least weekly. Upon resolution of the diarrhea, consider restarting COPIKTRA at a reduced dose.
For patients presenting with abdominal pain, stool with mucus or blood, change in bowel habits, peritoneal signs, or with severe diarrhea (Grade 3) (i.e., > 6 stools per day over baseline), withhold COPIKTRA and initiate supportive therapy with enteric acting steroids (e.g., budesonide) or systemic steroids. A diagnostic work-up to determine etiology, including colonoscopy, should be performed. Monitor at least weekly. Upon resolution of the diarrhea or colitis, restart COPIKTRA at a reduced dose. For recurrent Grade 3 diarrhea or recurrent colitis of any grade, discontinue COPIKTRA. Discontinue COPIKTRA for life-threatening diarrhea or colitis.
Cutaneous Reactions: Serious, including fatal (2/442; <1%), cutaneous reactions occurred in 5% of patients receiving COPIKTRA 25 mg BID (N=442). Fatal cases included drug reaction with eosinophilia and systemic symptoms (DRESS) and toxic epidermal necrolysis (TEN). Median time to onset of any grade cutaneous reaction was 3 months (range: 1 day to 29 months, 75th percentile: 6 months) with a median event duration of 1 month (range: 1 day to 37 months, 75th percentile: 2 months).
Presenting features for the serious events were primarily described as pruritic, erythematous, or maculo-papular. Less common presenting features include exanthem, desquamation, erythroderma, skin exfoliation, keratinocyte necrosis, and papular rash. Advise patients to report new or worsening cutaneous reactions. Review all concomitant medications and discontinue any medications potentially contributing to the event. For patients presenting with mild or moderate (Grade 1-2) cutaneous reactions, continue COPIKTRA at the current dose, initiate supportive care with emollients, antihistamines (for pruritus), or topical steroids, and monitor the patient closely. Withhold COPIKTRA for severe (Grade 3) cutaneous reaction until resolution. Initiate supportive care with steroids (topical or systemic) or antihistamines (for pruritus). Monitor at least weekly until resolved. Upon resolution of the event, restart COPIKTRA at a reduced dose. Discontinue COPIKTRA if severe cutaneous reaction does not improve, worsens, or recurs. For life-threatening cutaneous reactions, discontinue COPIKTRA. In patients with SJS, TEN, or DRESS of any grade, discontinue COPIKTRA.
Pneumonitis: Serious, including fatal (1/442; <1%), pneumonitis without an apparent infectious cause occurred in 5% of patients receiving COPIKTRA 25 mg BID (N=442). Median time to onset of any grade pneumonitis was 4 months (range: 9 days to 27 months), with 75% of cases occurring within 9 months. The median event duration was 1 month, with 75% of cases resolving by 2 months.
Withhold COPIKTRA in patients with new or progressive pulmonary signs and symptoms such as cough, dyspnea, hypoxia, interstitial infiltrates on a radiologic exam, or a decline by more than 5% in oxygen saturation, and evaluate for etiology. If the pneumonitis is infectious, patients may be restarted on COPIKTRA at the previous dose once the infection, pulmonary signs and symptoms resolve. For moderate non-infectious pneumonitis (Grade 2), treat with systemic corticosteroids and resume COPIKTRA at a reduced dose upon resolution. If non-infectious pneumonitis recurs or does not respond to steroid therapy, discontinue COPIKTRA. For severe or life-threatening non-infectious pneumonitis, discontinue COPIKTRA and treat with systemic steroids.
Hepatotoxicity: Grade 3 and 4 ALT and/or AST elevation developed in 8% and 2%, respectively, of patients receiving COPIKTRA 25 mg BID (N=442). Two percent of patients had both an ALT or AST > 3 X ULN and total bilirubin > 2 X ULN. Median time to onset of any grade transaminase elevation was 2 months (range: 3 days to 26 months), with a median event duration of 1 month (range: 1 day to 16 months).
Monitor hepatic function during treatment with COPIKTRA. For Grade 2 ALT/AST elevation (> 3 to 5 X ULN), maintain COPIKTRA dose and monitor at least weekly until return to < 3 X ULN. For Grade 3 ALT/AST elevation (> 5 to 20 X ULN), withhold COPIKTRA and monitor at least weekly until return to < 3 X ULN. Resume COPIKTRA at the same dose (first occurrence) or at a reduced dose for subsequent occurrences. For grade 4 ALT/AST elevation (> 20 X ULN), discontinue COPIKTRA.
Neutropenia: Grade 3 or 4 neutropenia occurred in 42% of patients receiving COPIKTRA 25 mg BID (N=442), with Grade 4 neutropenia occurring in 24% of all patients. Median time to onset of grade ≥3 neutropenia was 2 months (range: 3 days to 31 months), with 75% of cases occurring within 4 months.
Monitor neutrophil counts at least every 2 weeks for the first 2 months of COPIKTRA therapy, and at least weekly in patients with neutrophil counts < 1.0 Gi/L (Grade 3-4). Withhold COPIKTRA in patients presenting with neutrophil counts < 0.5 Gi/L (Grade 4). Monitor until ANC is > 0.5 Gi/L, then resume COPIKTRA at same dose for the first occurrence or at a reduced dose for subsequent occurrences.
Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, COPIKTRA can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Conduct pregnancy testing before initiating COPIKTRA treatment. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose.
ADVERSE REACTIONS
B-cell Malignancies Summary
Fatal adverse reactions within 30 days of the last dose occurred in 8% (36/442) of patients treated with COPIKTRA 25 mg BID. Serious adverse reactions were reported in 289 patients (65%). The most frequent serious adverse reactions that occurred were infection (31%), diarrhea or colitis (18%), pneumonia (17%), rash (5%), and pneumonitis (5%).
Adverse reactions resulted in treatment discontinuation in 156 patients (35%) most often due to diarrhea or colitis, infection, and rash. COPIKTRA was dose reduced in 104 patients (24%) due to adverse reactions, most often due to diarrhea or colitis and transaminase elevation. The most common adverse reactions (reported in ≥ 20% of patients) were diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain and anemia.
CLL/SLL: Fatal adverse reactions within 30 days of the last dose occurred in 12% (19/158) of patients treated with COPIKTRA and in 4% (7/155) of patients treated with ofatumumab. Serious adverse reactions were reported in 73% (115/158) of patients treated with COPIKTRA and most often involved infection (38%; 60/158) and diarrhea or colitis (23%; 36/158). COPIKTRA was discontinued in 57 patients (36%), most often due to diarrhea or colitis, infection, and rash. COPIKTRA was dose reduced in 46 patients (29%) due to adverse reactions, most often due to diarrhea or colitis and rash. The most common adverse reactions with COPIKTRA (reported in ≥20% of patients) were diarrhea or colitis, neutropenia, pyrexia, upper respiratory tract infection, pneumonia, rash, fatigue, nausea, anemia and cough.
FL: Serious adverse reactions were reported in 58% of patients and most often involved diarrhea or colitis, pneumonia, renal insufficiency, rash, and sepsis. The most common adverse reactions (≥20% of patients) were diarrhea or colitis, nausea, fatigue, musculoskeletal pain, rash, neutropenia, cough, anemia, pyrexia, headache, mucositis, abdominal pain, vomiting, transaminase elevation, and thrombocytopenia. Adverse reactions resulted in COPIKTRA discontinuation in 29% of patients, most often due to diarrhea or colitis and rash. COPIKTRA was dose reduced in 23% due to adverse reactions, most often due to transaminase elevation, diarrhea or colitis, lipase increased and infection.
DRUG INTERACTIONS
CYP3A Inducers: Coadministration with a strong CYP3A inducer may reduce COPIKTRA efficacy. Avoid coadministration with strong CYP3A4 inducers.
CYP3A Inhibitors: Coadministration with a strong CYP3A inhibitor may increase the risk of COPIKTRA toxicities. Reduce COPIKTRA dose to 15 mg BID when coadministered with a strong CYP3A4 inhibitor.
CYP3A Substrates: Coadministration of COPIKTRA with sensitive CYP3A4 substrates may increase the risk of toxicities of these drugs. Consider reducing the dose of the sensitive CYP3A4 substrate and monitor for signs of toxicities of the coadministered sensitive CYP3A substrate.
Please see the full Prescribing Information, including BOXED WARNING, and patient Medication Guide found on www.COPIKTRA.com.
About Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are cancers that affect lymphocytes and are essentially the same disease, with the only difference being the location where the cancer primarily occurs. When most of the cancer cells are located in the bloodstream and the bone marrow, the disease is referred to as CLL, although the lymph nodes and spleen are often involved. When the cancer cells are located mostly in the lymph nodes, the disease is called SLL. The symptoms of CLL/SLL include a tender, swollen abdomen and feeling full even after eating only a small amount. Other symptoms can include fatigue, shortness of breath, anemia, bruising easily, night sweats, weight loss, and frequent infections. However, many patients with CLL/SLL will live for years without symptoms. There are approximately 200,000 patients in the US affected by CLL/SLL with nearly 20,000 new diagnoses this year alone. While there are therapies currently available, real-world data reveals that a significant number of patients either relapse following treatment, become refractory to current agents, or are unable to tolerate treatment, representing a significant medical need. The potential of additional oral agents, particularly as a monotherapy that can be used in the general community physician’s armamentarium, may hold significant value in the treatment of patients with CLL/SLL.
About Follicular Lymphoma
Follicular lymphoma (FL) is typically a slow-growing or indolent form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes, making it a B-cell lymphoma. This lymphoma subtype accounts for 20 to 30 percent of all NHL cases, with more than 140,000 people in the US with FL and more than 13,000 newly diagnosed patients this year. Common symptoms of FL include enlargement of the lymph nodes in the neck, underarms, abdomen, or groin, as well as fatigue, shortness of breath, night sweats, and weight loss. Often, patients with FL have no obvious symptoms of the disease at diagnosis. Follicular lymphoma is usually not considered to be curable, but more of a chronic disease, with patients living for many years with this form of lymphoma. The potential of additional oral agents, particularly as a monotherapy that can be used in the general community physician’s armamentarium, may hold significant value in the treatment of patients with FL.
About COPIKTRA (duvelisib)
COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. COPIKTRA is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status, and is being investigated in combination with other agents through investigator-sponsored studies.4 For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.