Imdelltra Drug Information
Generic name: TARLATAMAB-DLLE
Uses of Imdelltra
is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMDELLTRA is a bispecific delta-like ligand 3 (DLL3)-directed CD3 T- cell engager indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum - based chemotherapy.
Dosage & Administration of Imdelltra
| Note: See | |
|---|---|
| Day 1 | |
| Day 8 | 10 mg |
| Day 15 | 10 mg |
| Cycle 2 | Day 1 and 15 |
| Cycles 3 and 4 | Day 1 and 15 |
| Cycle 5 and subsequent infusions | Day 1 and 15 |
Side Effects of Imdelltra
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in the WARNINGS AND PRECAUTIONS reflects exposure to intravenous IMDELLTRA, as a single agent, at the recommended dosage of IMDELLTRA 1 mg on Cycle 1 Day 1 followed by 10 mg on Days 8 and 15, and then every 2 weeks until disease progression or intolerable toxicity in 473 patients with small cell lung cancer enrolled in three clinical trials: DeLLphi-300, DeLLphi-301 and DeLLphi-304. Among 473 patients who received IMDELLTRA, 40% were exposed for 6 months or longer and 19% were exposed for greater than one year. The most common (≥ 20%) adverse reactions were CRS (57%), fatigue (48%), decreased appetite (38%), dysgeusia (34%), pyrexia (33%), constipation (31%), musculoskeletal pain (31%), and nausea (25%). The most common (≥ 5%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes (43%), decreased sodium (12%), decreased total neutrophils (9%), and increased uric acid (6%). Extensive Stage Small Cell Lung Cancer The safety of IMDELLTRA was evaluated in 252 patients in DeLLphi-304, a multicenter, randomized, open label trial in patients with extensive stage small cell lung cancer (ES- SCLC) with disease progression following treatment with platinum-based chemotherapy with or without an anti-PD-(L)1 antibody.
Patients received IMDELLTRA (n=252) or investigator's choice or investigator's choice of topotecan, lurbinectedin or amrubicin. Among patients who received IMDELLTRA, 41% were exposed for 6 months or longer and 18% were exposed for greater than one year. The demographic characteristics of patients who received IMDELLTRA were: median age 64 years (range: 20 to 86); 71% male; 60% White, 38 % Asian, 0.8% Black or African American; and 4.8% were of Hispanic or Latino ethnicity.
Serious adverse reactions occurred in 52% of patients who received IMDELLTRA. Serious adverse reactions in >3% of patients included CRS (17%), pyrexia (6%), pneumonia (5%) and ICANS (3.6%). Fatal adverse reactions occurred in 8% of patients who received IMDELLTRA, including one fatal adverse reaction of ICANS (0.4%). Fatal adverse reactions occurring in more than one patient included pneumonia (1.6%), cardio-respiratory arrest (1.6%), and sepsis (0.8%). Permanent discontinuation of IMDELLTRA due to an adverse reaction occurred in 6% of patients. Adverse reactions which resulted in permanent discontinuation of IMDELLTRA in > 1% of patients included pneumonia (1.2%). Dosage interruptions of IMDELLTRA due to an adverse reaction occurred in 38% of patients. Adverse reactions which required dosage interruption in ≥ 2% of patients included neutropenia (5%), fatigue (4.4%), pneumonia (4%), decreased appetite (2.8%), COVID-19 (2%). Table 13 summarizes adverse reactions observed in DeLLphi-304. Table 13. Adverse Reactions (≥ 15%) in Patients with SCLC Who Received IMDELLTRA in DeLLphi-304 Adverse Reaction IMDELLTRA Graded using CTCAE Version 4.0 and Version 5.0. (N = 252) Standard of Care (N = 244) Any Grade (%) Grade 3 or 4 (%) Any Grade (%) Grade 3 or 4 (%) Immune system disorders Cytokine release syndrome Based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019. 56 1.2 1.2 0 General disorders and administration site conditions Fatigue Includes fatigue and asthenia 39 6 43 10 Pyrexia Includes body temperature increased, hyperthermia, pyrexia 29 1.2 11
Metabolism and nutrition disorders Decreased appetite 37 2 23 1.6 Gastrointestinal disorders
Constipation 30 0.4 22 0 Nausea 25 0.4 32 0 Nervous system disorders Dysgeusia Includes ageusia, dysgeusia, hypogeusia 28 0 2.5 0 Headache Includes headache and tension headache 16 0 9 0 Musculoskeletal and connective tissue disorders Musculoskeletal pain Includes arthralgia, back pain, bone pain, musculoskeletal pain, myalgia, neck pain, non-cardiac chest pain, pain in extremity, spinal pain 27 1.6 21
Respiratory, thoracic and mediastinal disorders Cough Includes cough and productive cough 17
0 17 0 Clinically relevant adverse reactions occurring in < 15% of patients who received IMDELLTRA were immune effector cell-associated neurotoxicity syndrome, neurotoxicity, tremor, seizure, ataxia, confusional state, delirium, dyspnea, encephalopathy and weight decreased. Table 14 summarizes laboratory abnormalities in DeLLphi-304. Table 14. Laboratory Abnormalities (≥ 20%) That Worsened from Baseline in Patients with SCLC in DeLLphi-304 Laboratory Abnormality IMDELLTRA The denominator used to calculate the rate varied for IMDELLTRA (Range: 229 to 250) and SOC (Range: 205 to 226) based on the number of patients with a baseline value and at least one post-treatment value. N=252 Standard of care N=244 All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%) Hematology Lymphocytes decreased 65 27 62 27 Hemoglobin decreased 51 4.5 86 29 White blood cells decreased 50 7 70 29 Platelets decreased 25 0.4 55 20 Neutrophils decreased All Grade lab abnormalities occurring at a frequency less than 20% included decreased neutrophils. 15 10 44 36 Chemistry Sodium decreased 57 8 38 7 Potassium decreased 41 4.8 34 4 Aspartate amino transferase increased 40 2.8 29
Activated Partial Thromboplastin Time (sec) increased 26 1.3 16 0.9 Creatinine increased
23 0.8 19
Potassium increased 21 0.8 12 1.8 Creatine Phosphokinase increased 21 1.7 11
0 DeLLphi-300 and DeLLphi-301 The safety of IMDELLTRA, as a single agent, at the recommended dosage was evaluated in patients with extensive stage small cell lung cancer enrolled in DeLLphi-300 and DeLLphi-301. Among 187 patients who received IMDELLTRA, 31% were exposed for 6 months or longer and 14% were exposed for greater than one year. The demographic characteristics of patients who received IMDELLTRA were: median age 66 years (range: 35 to 82); 65% male; 70% White, 26% Asian, 2.1% Black or African American; and 2.1% Hispanic or Latino. Serious adverse reactions occurred in 58% of patients who received IMDELLTRA. Serious adverse reactions in >3% of patients included cytokine release syndrome (24%), pneumonia (6%), pyrexia (3.7%) and hyponatremia (3.6%). Fatal adverse reactions occurred in 2.7% of patients who received IMDELLTRA including pneumonia 0.5%, aspiration (0.5%), pulmonary embolism (0.5%), respiratory acidosis (0.5%), and respiratory failure (0.5%). Permanent discontinuation of IMDELLTRA due to an adverse reaction occurred in 7% of patients.
Adverse reactions which resulted in permanent discontinuation of IMDELLTRA in >1% of patients included cytokine release syndrome (1.6%) and tumor lysis syndrome (1.1%). Dosage interruptions of IMDELLTRA due to an adverse reaction occurred in 27% of patients. Adverse reactions which required dosage interruption in ≥ 2% of patients included fatigue (3.2%), cytokine release syndrome (2.7%) and respiratory tract infection (2.1%). Table 15 summarizes adverse reactions observed in DeLLphi-300 and DeLLphi-301. Table 15. Adverse Reactions (≥ 15%) in Patients with ES-SCLC Who Received IMDELLTRA in DeLLphi-300 and DeLLphi-301 Adverse Reaction IMDELLTRA Graded using CTCAE Version 4.0 and Version 5.0. (N = 187) Any Grade (%) Grade 3 or 4 (%) Immune system disorders Cytokine release syndrome Based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019. 55
General disorders and administration site conditions Fatigue Includes fatigue and asthenia. 51
10 Pyrexia 36 0 Nervous system disorders Dysgeusia 36 0 Metabolism and nutrition disorders Decreased appetite 34
Nausea 22 1.6 Gastrointestinal disorders Constipation 30 0.5 Musculoskeletal and connective tissue
disorders Musculoskeletal pain Includes myalgia, arthralgia, back pain, pain in extremity, neck pain, musculoskeletal chest pain, non- cardiac chest pain and bone pain. 30
Cough 17 0 Table 16 summarizes laboratory abnormalities in DeLLphi-300 and DeLLphi-301
IMDELLTRA The denominator used to calculate the rate varied from 41 to 187 based on the number of patients with a baseline value and at least one post-treatment value. All Grades (%) Grade 3 or 4 (%) Laboratory Abnormality Hematology Lymphocytes decreased 84 57 Hemoglobin decreased 58 5 White blood cells decreased 44
Platelets decreased 33 3.2 Neutrophils decreased All Grade lab abnormalities occurring at
a frequency less than 20% included decreased neutrophils. 12 6 Chemistry Sodium decreased 68 16 Potassium decreased 50 5 Aspartate amino transferase increased 44
Warnings & Cautions for Imdelltra
Cytokine Release Syndrome
IMDELLTRA can cause cytokine release syndrome (CRS) including life-threatening or fatal reactions. In the pooled safety population , CRS occurred in 57% (268/473) of patients who received IMDELLTRA, including 39% Grade 1, 15% Grade 2, 1.7% Grade 3 and 0.2% Grade 4. Recurrent CRS occurred in 24% of IMDELLTRA-treated patients including 20% Grade 1 and 3.4% Grade 2; one patient experienced recurrent Grade 3. Among the 268 patients who experienced CRS, 73% had CRS after the first dose, 60% had CRS after the second dose, and 15% had CRS following the third or later dose. Following the Cycle 1 Day 1, Day 8, Day 15 infusions, 24%, 8%, and 1% of patients experienced Grade ≥ 2 CRS, respectively.
From Cycle 2 onwards, 1.5% of patients experienced Grade ≥ 2 CRS. Of the patients who experienced CRS, 31% received steroids and 10% required tocilizumab. The median time to onset of all grade CRS from most recent dose of IMDELLTRA was 16 hours (range: start of infusion to 15 days). The median time to onset of Grade ≥ 2 CRS from most recent dose of IMDELLTRA was 15 hours (range: start of infusion to 15 days). Clinical signs and symptoms of CRS included pyrexia, hypotension, fatigue, tachycardia, headache, hypoxia, nausea and vomiting. Potentially life-threatening complications of CRS may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC). Administer IMDELLTRA following the recommended step-up dosing and administer concomitant medications before and after Cycle 1 Day 1 and Cycle 1 Day 8 IMDELLTRA infusions as described in Table 3 to reduce the risk of CRS . Administer IMDELLTRA in an appropriate healthcare facility equipped to monitor and manage CRS. Ensure patients are well hydrated prior to administration of IMDELLTRA. Closely monitor patients for signs and symptoms of CRS during treatment with IMDELLTRA. At the first sign of CRS, immediately discontinue IMDELLTRA infusion, evaluate the patient for hospitalization and institute supportive care based on severity.
Withhold or permanently discontinue IMDELLTRA based on severity . Counsel patients and caregivers to seek medical attention should signs or symptoms of CRS occur.
Neurologic Toxicity Including
ICANS IMDELLTRA can cause life-threatening or fatal neurologic toxicity including ICANS. In the pooled safety population , neurologic toxicity occurred in 65% of patients who received IMDELLTRA, with Grade 3 or higher events in 7% of patients including fatal events in 0.2%. The most frequent neurologic toxicities were dysgeusia (34%), headache (17%), peripheral neuropathy (9%), dizziness (9%), and insomnia (8%). The incidence of signs and symptoms consistent with ICANS was 10% in IMDELLTRA- treated patients, including events with the preferred terms: ICANs (4.7%), muscular weakness (3.2%), cognitive disorder (0.6%), aphasia (0.6%), depressed level of consciousness (0.4%), seizures (0.4%), encephalopathy (0.4%), and leukoencephalopathy (0.2%). There was one fatal reaction of ICANS . Recurrent ICANS occurred in 1.5% of patients. Of the patients who experienced ICANS, most experienced the event following Cycle 1 Day 1 (2.5%) and Cycle 1 Day 8 (3.6%). Following Day 1, Day 8, and Day 15 infusions, 1.3%, 1.3% and 0.4% of patients experienced Grade ≥ 2 ICANS, respectively. ICANS can occur several weeks following administration of IMDELLTRA. The median time to onset of ICANS from the first dose of IMDELLTRA was 16 days (range: 1 to 862 days). The median time to resolution of ICANS was 4 days (range: 1 to 40 days). The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Clinical signs and symptoms of ICANS may include but are not limited to confusional state, depressed level of consciousness, disorientation, somnolence, lethargy, and bradyphrenia.
Patients receiving IMDELLTRA are at risk of neurologic adverse reactions and ICANS resulting in depressed level of consciousness. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, until neurologic symptoms resolve. Closely monitor patients for signs and symptoms of neurologic toxicity and ICANS during treatment with IMDELLTRA. At the first sign of ICANS, immediately discontinue the infusion, evaluate the patient and provide supportive therapy based on severity.
Withhold IMDELLTRA or permanently discontinue based on severity .
Cytopenias
IMDELLTRA can cause cytopenias including neutropenia, thrombocytopenia, and anemia. In the pooled safety population, based on laboratory data, decreased neutrophils occurred in 16% of patients, including 9% Grade 3 or 4. The median time to onset for Grade 3 or 4 decreased neutrophil count was 41 days (range: 2 to 306 days). Decreased platelets occurred in 30%, including 2.2% Grade 3 or 4. The median time to onset for Grade 3 or 4 decreased platelets was 67 days (range: 3 to 420 days). Decreased hemoglobin occurred in 56% of patients, including 4.7% Grade 3 or 4. Febrile neutropenia was reported as an adverse event in 1.5% of patients treated with IMDELLTRA. Monitor patients for signs and symptoms of cytopenias. Perform complete blood counts prior to treatment with all doses of IMDELLTRA, up through Cycle 5 Day 15 and then prior to administration of IMDELLTRA on Day 1 of each cycle starting with Cycle 6. Based on the severity of cytopenias, temporarily withhold or permanently discontinue IMDELLTRA .
Infections
IMDELLTRA can cause serious infections, including life-threatening and fatal infections. In the pooled safety population, , infections including opportunistic infections occurred in 43% of patients who received IMDELLTRA, including 14% Grade 3 or 4. The most frequent infections were pneumonia (11%), urinary tract infection (9%), COVID-19 (6%), upper respiratory tract infection (4.7%), respiratory tract infection (4%), candida infection (2.1%), oral candidiasis (2.1%) and nasopharyngitis (2.1%). Monitor patients for signs and symptoms of infection prior to and during treatment with IMDELLTRA and treat as clinically indicated. Withhold or permanently discontinue IMDELLTRA based on severity .
Hepatotoxicity
IMDELLTRA can cause hepatotoxicity. In the pooled safety population , based on laboratory data, elevated ALT occurred in 39% of patients who received IMDELLTRA, including 2.5% Grade 3 or 4 ALT. Elevated AST occurred in 43% of patients, including 3.2% Grade 3 or 4. Elevated bilirubin occurred in 16% of patients, including 1.3% Grade 3 or 4 . Liver enzyme elevation can occur with or without concurrent CRS. Monitor liver enzymes and bilirubin prior to treatment with IMDELLTRA, and as clinically indicated. Withhold IMDELLTRA or permanently discontinue based on severity .
Hypersensitivity
IMDELLTRA can cause severe hypersensitivity reactions. Clinical signs and symptoms of hypersensitivity may include, but are not limited to, rash and bronchospasm. Monitor patients for signs and symptoms of hypersensitivity during treatment with IMDELLTRA and manage as clinically indicated.
Withhold or consider permanent discontinuation of IMDELLTRA based on severity .
Embryo-Fetal Toxicity
Based on its mechanism of action, IMDELLTRA may cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IMDELLTRA and for 2 months after the last dose .
Pregnancy Safety for Imdelltra
Pregnancy Risk Summary Based on its mechanism of action, IMDELLTRA may cause fetal harm when administered to a pregnant woman . There are no available data on the use of IMDELLTRA in pregnant women to inform a drug-associated risk. In an animal reproduction study, a murine surrogate molecule administered intravenously to pregnant mice crossed the placental barrier. Tarlatamab-dlle causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance.
Human immunoglobulin G (IgG) and proteins comprising IgG-derived fragment crystallizable (Fc) domains are known to cross the placental barrier; therefore, IMDELLTRA has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% - 20%, respectively.
Data Animal Data Animal reproduction studies have not been conducted with tarlatamab-dlle. In an embryo-fetal developmental toxicity study, a murine surrogate molecule was administered intravenously to pregnant mice during the period of organogenesis. The surrogate molecule crossed the placental barrier and did not cause maternal toxicity, embryo-fetal toxicity or teratogenicity.
Pediatric Use of Imdelltra
Pediatric Use The safety and effectiveness of IMDELLTRA have not been established in pediatric patients.
Clinical Studies of Imdelltra
Small Cell Lung Cancer DeLLphi-304
The efficacy of IMDELLTRA was evaluated in DeLLphi-304 (NCT05740566), a multicenter, randomized, open-label trial. Eligible patients were required to have SCLC with disease progression following treatment with platinum-based chemotherapy with or without an anti-PD-(L)1 antibody. Patients were required to have an ECOG Performance Status of 0 or 1 and at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Patients with symptomatic brain metastases or active immunodeficiency were ineligible.
A total of 509 patients were randomized 1:1 to receive either IMDELLTRA (N=254) at an initial dose of 1 mg on Cycle 1 Day 1 followed by 10 mg on Days 8, 15, and every 2 weeks thereafter until disease progression or unacceptable toxicity or Investigator's choice of standard of care (SOC) chemotherapy (N=255) (topotecan, lurbinectedin or amrubicin ) until unacceptable toxicity or disease progression. Randomization was stratified by prior anti-PD-(L)1 exposure (yes versus no), platinum sensitivity status (chemotherapy-free interval (CFI) ≥ 180 days, < 180 to ≥ 90 days, or < 90 days), presence (previous or current) of brain metastases (yes versus no) and investigator's choice of standard of care (topotecan/amrubicin versus lurbinectedin). The median age was 65 years (range: 20 to 86); 52% age 65 or older; 69% male; 57% White, 40% Asian, 1.4% were other races or had race not reported, 1% Black or African American, 0.4% American Indian or Alaska Native; 32% had ECOG PS of 0 and 67% ECOG PS of 1; 100% had extensive stage disease at baseline of whom 91% had metastatic disease; 45% had brain metastases at baseline; 35% had liver metastases at baseline. Sixty-nine percent (69%) of patients were former smokers, 21% were current smokers, 11% were never smokers.
All patients received prior platinum therapy; 71% received prior anti-PD-(L)1 therapy; 223 patients (44%) had chemotherapy-free interval < 90 days after end of first line platinum therapy, while 286 patients (56%) had chemotherapy-free interval ≥ 90 days. The major efficacy outcome measure was overall survival (OS). Key secondary efficacy outcome measures included progression-free survival (PFS) based on investigator assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) and select patient reported outcomes. Efficacy results are summarized in Table 18 and Figure 1. Table 18. Efficacy Results for Patients with SCLC who received IMDELLTRA Efficacy Parameter IMDELLTRA (N = 254) Standard of Care (N = 255) Overall Survival (OS) Deaths (%) 111 152 Median per Kaplan-Meier estimates in months (95% CI) 13.6 (11.1, NE)
Hazard ratio Hazard ratio based on the stratified Cox proportional hazard model
(95% CI) 0.60 p-value p-value based on the stratified log-rank test <0.001 Progression-free Survival (PFS) PFS based on investigator assessment per RECIST
Events (%) 191 205 Median in months (95% CI) 4.2 3.2 Hazard
ratio (95% CI) 0.72 p-value <0.001 In a pre-specified exploratory subgroup analysis, the HR for OS was similar between patients with a chemotherapy-free interval (CFI) <90 days (n=223) and patients with a CFI ≥90 days (n=286), with HRs of 0.60 (95% CI: 0.43, 0.84) and 0.65 (95% CI: 0.45, 0.93), respectively. Figure 1: Kaplan-Meier Plot of Overall Survival in ITT on DeLLphi-304 The analysis of mean change from baseline in dyspnea as assessed using the EORTC QLQ-C30 and EORTC QLQ-LC13 at week 18 demonstrated a statistically significant improvement in patients randomized to IMDELLTRA compared to SOC. At week 18, 149 patients (59%) randomized to IMDELLTRA and 116 (45%) patients randomized to SOC were still on treatment, and the compliance rates were 79% and 76% respectively at that timepoint. Figure 2 shows the change from baseline in dyspnea at week 18 in patients who had a change from baseline score at week 18 (n=116 for IMDELLTRA, n=88 for SOC). Two patients with a missing baseline value, both from the IMDELLTRA arm, are not included in the waterfall plot.
Patients with no change in dyspnea score are not graphically represented in Figure 2 (n=38 for IMDELLTRA, n=26 for SOC). Figure 2: Waterfall plot of Change From Baseline in Dyspnea (Composite Score) at Week 18 DeLLphi-301 The efficacy of IMDELLTRA was evaluated in DeLLphi-301, an open- label, multicenter, multi-cohort clinical trial. Eligible patients were required to have relapsed/refractory SCLC with disease progression after receiving previous treatment with platinum-based chemotherapy and at least one other line of prior therapy, an ECOG Performance Status of 0 or 1, and at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1). The trial excluded patients with symptomatic brain metastases, evidence of interstitial lung disease or non-infectious pneumonitis, and active immunodeficiency. A total of 99 patients received IMDELLTRA intravenously at an initial dose of 1 mg on Cycle 1 Day 1 followed by 10 mg on Days 8, 15, and every 2 weeks thereafter until disease progression or unacceptable toxicity.
The study population characteristics were: median age 64 years (range: 35 to 82); 48% of patients ≥ 65 years and 10% of patients ≥ 75 years; 72% male; 58% White, 41% Asian; 1% Hispanic or Latino; and 74% have ECOG 1. Ninety-seven percent of patients had metastatic disease at baseline; 22% had brain metastases at baseline; and 92% were former/current smokers. All patients received prior platinum-based chemotherapy (median two lines); 74% received prior anti-PD-(L)1 therapy (including 59% who received anti-PD1 therapy in combination with platinum-based chemotherapy in the frontline setting); 51% received prior topoisomerase I inhibitor (including 20% who received topotecan). Platinum sensitivity status, defined by time to progression after first line platinum therapy, was known for 69/99 patients. Twenty-seven patients (27%) had platinum-resistant SCLC, defined as time to progression < 90 days after first line platinum therapy, while 42 patients (42%) had platinum-sensitive SCLC. Tumor assessments were performed every 6 weeks for the first 48 weeks and every 12 weeks thereafter.
The major efficacy outcome measures were overall response rate (ORR) and duration of response (DOR) as evaluated by Blinded Independent Central Review (BICR) according to RECIST v1.1. Efficacy results are presented in Table 19. Table 19. Efficacy Results for DeLLphi-301 Efficacy Parameter IMDELLTRA (N = 99) Overall Response Rate (ORR) ORR, % (95% CI) Assessed by Blinded Independent Central Review, CI = Confidence Interval 40 Complete Response, n (%) 2 Partial Response, n (%) 38 Duration of Response (DOR) Median Median based on Kaplan-Meier estimate., months (range) 9.7 (2.7, 20.7+) Duration ≥ 6 months Based on observed duration of response., % 68 Duration ≥ 12 months, % 40 Of the 69 patients with available data regarding platinum sensitivity status, the ORR was 52% (95% CI: 32, 71) in 27 patients with platinum-resistant SCLC and 31% (95% CI: 18, 47) in 42 patients with platinum-sensitive SCLC. Figure 1 Figure 2
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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