Pluvicto Drug Information

Generic name: LUTETIUM LU 177 VIPIVOTIDE TETRAXETAN

Radioligand Therapeutic Agent [EPC]

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Uses of Pluvicto

is indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy, and are considered appropriate to delay taxane-based chemotherapy, or have received prior taxane-based chemotherapy. PLUVICTO is a radioligand therapeutic agent indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy, and are considered appropriate to delay taxane-based chemotherapy, or have received prior taxane-based chemotherapy.

Dosage & Administration of Pluvicto

Abbreviations: CLcr, creatinine clearance; AST, aspartate aminotransferase; ALT, alanine aminotransferase; ULN, upper limit of normal. Grading according to most current Common Terminology Criteria for Adverse Events (CTCAE).
Adverse reactionSeverity
Myelosuppression (Anemia, thrombocytopenia, leukopenia, or neutropenia) [see Warnings and Precautions (5.2)]Grade 2
Grade ≥ 3Withhold PLUVICTO until improvement to Grade 1 or baseline. Reduce PLUVICTO dose by 20% to 5.9 GBq (160 mCi).
Recurrent Grade ≥ 3 myelosuppression after one dose reductionPermanently discontinue PLUVICTO.
Renal toxicity [see Warnings and Precautions (5.3)]Defined as:
  • Confirmed serum creatinine increase (Grade ≥ 2)
  • Confirmed CLcr < 30 mL/min; calculate using Cockcroft-Gault with actual body weight
Defined as:
  • Confirmed ≥ 40% increase from baseline serum creatinine and
  • Confirmed > 40% decrease from baseline CLcr; calculate using Cockcroft-Gault with actual body weight
Withhold PLUVICTO until improvement or return to baseline. Reduce PLUVICTO dose by 20% to 5.9 GBq (160 mCi).
Grade ≥ 3 renal toxicityPermanently discontinue PLUVICTO.
Recurrent renal toxicity after one dose reductionPermanently discontinue PLUVICTO.
Dry mouth [see Adverse Reactions (6.1)]Grade 2
Grade 3Withhold PLUVICTO until improvement or return to baseline. Reduce PLUVICTO dose by 20% to 5.9 GBq (160 mCi).
Recurrent Grade 3 dry mouth after one dose reductionPermanently discontinue PLUVICTO.
Gastrointestinal toxicity [see Adverse Reactions (6.1)]Grade ≥ 3 (not amenable to medical intervention)
Recurrent Grade ≥ 3 gastrointestinal toxicity after one dose reductionPermanently discontinue PLUVICTO.
Fatigue [see Adverse Reactions (6.1)]Grade ≥ 3
Electrolyte or metabolic abnormalities [see Adverse Reactions (6.1)]Grade ≥ 2
Other non-hematologic toxicity [see Adverse Reactions (6.1)]Any unacceptable toxicity
Any adverse reaction that requires treatment delay of > 4 weeksPermanently discontinue PLUVICTO.
Any recurrent Grade 3 or 4 or persistent and intolerable Grade 2 adverse reaction after one dose reductionPermanently discontinue PLUVICTO.

Side Effects of Pluvicto

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. In the pooled safety population for the PSMAfore and VISION studies (N = 756), the most common (≥ 20%) adverse reactions, including laboratory abnormalities, were decreased lymphocytes (83%), decreased hemoglobin (65%), fatigue (49%), dry mouth (46%), decreased platelets (40%), decreased estimated glomerular filtration rate (37%), nausea (35%), decreased neutrophils (31%), decreased calcium (29%), decreased sodium (27%), increased aspartate aminotransferase (26%), increased alkaline phosphatase (24%), arthralgia (22%), decreased appetite (21%), increased potassium (21%), constipation (21%), and back pain (21%). PSMAfore The safety of PLUVICTO was evaluated in the PSMAfore study in patients with progressive, PSMA-positive mCRPC previously treated with ARPI therapy, for whom it was considered appropriate to delay taxane-based chemotherapy by the investigator . Patients received at least one dose of either PLUVICTO

GBq (200 mCi) administered every 6 weeks (N = 227) or a

change in ARPI (N = 232). The median duration of exposure to PLUVICTO was 8.4 months (range, 0.4 to 11.6), and the median number of doses of PLUVICTO received was 6 (range, 1 to 6). The median cumulative administered activity of PLUVICTO was

GBq (range, 7.0 to 45.4). Serious adverse reactions occurred in 20% of

patients who received PLUVICTO. Serious adverse reactions in > 1% of patients who received PLUVICTO included anemia (1.8%), urinary tract infection (1.8%), hemorrhage (1.3%), and sepsis (1.3%). Fatal adverse reactions occurred in 1.8% of patients who received PLUVICTO, including COVID-19 pneumonia, cardiac arrest, intestinal ischemia, and sepsis (0.4% each). PLUVICTO was permanently discontinued due to adverse reactions in 6% of patients. Adverse reactions leading to permanent discontinuation of PLUVICTO in ≥ 1% of patients who received PLUVICTO were thrombocytopenia (1.8%) and dry mouth (1.3%). Adverse reactions leading to a dose interruption of PLUVICTO occurred in 12% of patients. The most frequent (≥ 1%) adverse reactions leading to a dose interruption of PLUVICTO in patients who received PLUVICTO were COVID-19 (3.1%) and anemia (1.8%). Adverse reactions leading to a dose reduction of PLUVICTO occurred in 3.5% of patients.

The most frequent (≥ 0.5%) adverse reaction leading to a dose reduction of PLUVICTO in patients who received PLUVICTO was dry mouth (0.9%). Table 3 and Table 4 summarize the incidence of adverse reactions and laboratory abnormalities, respectively, in PSMAfore. Table 3: Adverse Reactions (≥ 10%) in Patients With PSMA-Positive mCRPC Who Received PLUVICTO in PSMAfore Abbreviation: ARPI, androgen receptor pathway inhibitor. a Includes multiple similar terms. Adverse reactions PLUVICTO (N = 227) ARPI (N = 232) All Grades (%) Grades 3 or 4 (%) All Grades (%) Grades 3 or 4 (%) Gastrointestinal disorders Dry mouth a 61 0.9 2.6 0 Nausea 32 0 12

Constipation 22 0.4 14 0 Diarrhea 17 0 9 0.4 Vomiting 11

0 4.7 0 General disorders Fatigue a 53 1.3 53 5 Metabolism and nutrition disorders Decreased appetite 22 0 19

Musculoskeletal and connective tissue disorders Arthralgia 20 0 23 0.4 Back pain

14 1.3 20

Clinically relevant adverse reactions in < 10% of patients who received

PLUVICTO included dysgeusia, abdominal pain, peripheral edema, headache, acute kidney injury, weight decreased, urinary tract infection, dry eye, dizziness, dry skin, oral fungal infection, gastroesophageal reflux disease, pyrexia, vertigo, stomatitis, dysphagia, esophagitis, pancytopenia, and bone marrow failure. Table 4: Select Laboratory Abnormalities (≥ 10%) That Worsened From Baseline in Patients With PSMA-Positive mCRPC Who Received PLUVICTO or Change in ARPI (Between Arm Difference of ≥ 5% All Grades) in PSMAfore Abbreviation: ARPI, androgen receptor pathway inhibitor. a The denominator used to calculate the rate for each laboratory parameter was based on 226 patients with a baseline value and at least one post-treatment value. b The denominator used to calculate the rate for each laboratory parameter varied from 231 to 232 based on the number of patients with a baseline value and at least one post-treatment value. c No Grade 4 laboratory abnormalities worsening from baseline were reported. Laboratory abnormalities PLUVICTO a ARPI b All Grades (%) Grades 3 or 4 (%) All Grades (%) Grades 3 or 4 (%) Hematology Decreased lymphocytes 78 27 57 12 Decreased hemoglobin 67 7 c 50 7 c Decreased neutrophils 38 3.5 18

Decreased platelets 30 2.7 11 1.7 Chemistry Increased alkaline phosphatase 31 8

50 10 c Decreased estimated glomerular filtration rate (eGFR) 23 0.9 c 22

Increased magnesium 19 0.9 c 28 0 c Decreased calcium 18 0.9

11

Decreased sodium 11 0 c 18 0 c Decreased potassium 6 0.9

c 18

VISION

The safety of PLUVICTO was evaluated in the VISION study in patients with progressive, PSMA-positive mCRPC previously treated with ARPI therapy and taxane-based chemotherapy . Patients received at least one dose of either PLUVICTO

GBq (200 mCi) administered every 6 weeks plus BSoC (N = 529)

or BSoC alone (N = 205). The median duration of exposure to PLUVICTO plus BSoC was 7.8 months (range, 0.3 to 36.5). Among patients who received PLUVICTO plus BSoC, the median number of doses of PLUVICTO received was 5 (range, 1 to 6). The median cumulative administered activity of PLUVICTO was

GBq (range, 7.0 to 48.3). Serious adverse reactions occurred in 37% of

patients who received PLUVICTO plus BSoC. Serious adverse reactions in > 1% of patients who received PLUVICTO plus BSoC included musculoskeletal pain (4%), hemorrhage (4%), sepsis (3.2%), urinary tract infection (3%), anemia (2.8%), acute kidney injury (1.9%), pneumonia (1.7%), pyrexia (1.5%), pancytopenia (1.3%), spinal cord compression (1.1%), and pulmonary embolism (1.1%). Fatal adverse reactions occurred in 3% of patients who received PLUVICTO plus BSoC, including sepsis (0.9%), pancytopenia (0.6%), hepatic failure (0.4%), intracranial hemorrhage (0.2%), subdural hematoma (0.2%), ischemic stroke (0.2%), COVID-19 (0.2%), and aspiration pneumonia (0.2%). PLUVICTO was permanently discontinued due to adverse reactions in 12% of patients. Adverse reactions leading to permanent discontinuation of PLUVICTO in ≥ 1% of patients who received PLUVICTO plus BSoC were anemia (2.8%), thrombocytopenia (2.8%), and leukopenia (including neutropenia) (1.7%). Adverse reactions leading to a dose interruption of PLUVICTO occurred in 16% of patients. The most frequent (≥ 3%) adverse reactions leading to a dose interruption of PLUVICTO in patients who received PLUVICTO plus BSoC were anemia (5%) and thrombocytopenia (3.6%). Adverse reactions leading to a dose reduction of PLUVICTO occurred in 6% of patients.

The most frequent (≥ 1%) adverse reactions leading to a dose reduction of PLUVICTO in patients who received PLUVICTO plus BSoC were thrombocytopenia (1.9%) and anemia (1.3%). Table 5 and Table 6 summarize the incidence of adverse reactions and laboratory abnormalities, respectively, in VISION. Table 5: Adverse Reactions (≥ 10%) in Patients With PSMA-Positive mCRPC Who Received PLUVICTO Plus BSoC in VISION Abbreviation: BSoC, best standard of care. a Includes multiple similar terms. Adverse reactions PLUVICTO plus BSoC (N = 529) BSoC (N = 205) All Grades (%) Grades 3 or 4 (%) All Grades (%) Grades 3 or 4 (%) General disorders Fatigue a 48 7 29

Decreased appetite 21 1.9 15 0.5 Weight decreased 11 0.4 10 0.5

Peripheral edema a 10 0.4 7 1 Gastrointestinal disorders Dry mouth a 39 0 1 0 Nausea 36 1.3 17

Constipation 20 1.1 11 0.5 Vomiting a 19 0.9 6 0.5 Diarrhea

19 0.8 2.9

Abdominal pain a 12 1.3 6 0.5 Musculoskeletal and connective tissue disorders

Back pain 24 3.6 15

Arthralgia 22 1.1 13 0.5 Bone pain 11 2.5 8 2.4 Renal

and urinary disorders Urinary tract infection a 12 3.8 1

Clinically relevant adverse reactions in < 10% of patients who received

PLUVICTO plus BSoC included acute kidney injury, dizziness, dysgeusia, headache, pyrexia, dry eye, oral fungal infection, vertigo, gastroesophageal reflux disease, stomatitis, pancytopenia, dry skin, dysphagia, esophagitis, and bone marrow failure. Table 6: Select Laboratory Abnormalities (≥ 10%) That Worsened From Baseline in Patients With PSMA-Positive mCRPC Who Received PLUVICTO Plus BSoC (Between Arm Difference of ≥ 5% All Grades) in VISION Abbreviation: BSoC, best standard of care. a The denominator used to calculate the rate for each laboratory parameter varied from 506 to 529 based on the number of patients with a baseline value and at least one post-treatment value. b The denominator used to calculate the rate for each laboratory parameter varied from 194 to 198 based on the number of patients with a baseline value and at least one post-treatment value. c No Grade 4 laboratory abnormalities worsening from baseline were reported. Laboratory abnormalities PLUVICTO plus BSoC a BSoC b All Grades (%) Grades 3 or 4 (%) All Grades (%) Grades 3 or 4 (%) Hematology Decreased lymphocytes 85 47 51 18 Decreased hemoglobin 64 15 c 34 7 c Decreased platelets 45 9 20

Decreased neutrophils 28 4.7 9 0.5 Chemistry Decreased estimated glomerular filtration rate

(eGFR) 43 3.6 28

Increased aspartate aminotransferase (AST) 29 1.1 18 1 c Increased potassium 24

0.6 18 0.5 c Increased sodium 11 0 c 5 0 c

Warnings & Cautions for Pluvicto

Risk From Radiation Exposure

PLUVICTO contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Minimize radiation exposure to patients, medical personnel, and others during and after treatment with PLUVICTO consistent with institutional good radiation safety practices, patient treatment procedures, Nuclear Regulatory Commission patient-release guidance, and instructions to the patient for follow-up radiation protection at home.

Ensure patients increase oral fluid intake and advise patients to void as often as possible to reduce bladder radiation. Before the patient is released, inform patients about the necessary radioprotection precautions to follow to minimize radiation exposure to others . After each administration of PLUVICTO, advise patients to: Limit close contact (less than 3 feet) with others for 2 days or with children and pregnant women for 7 days. Refrain from sexual activity for 7 days.

Sleep in a separate room from others for 3 days, from children for 7 days, or from pregnant women for 15 days.

Myelosuppression

PLUVICTO can cause severe and life-threatening myelosuppression, including anemia, thrombocytopenia, leukopenia, and neutropenia. In the PSMAfore study, Grade 3 or 4 decreased hemoglobin (7%), decreased leukocytes (4.4%), decreased neutrophils (3.5%), and decreased platelets (2.7%) occurred in patients treated with PLUVICTO. One death occurred due to bone marrow failure during long-term follow-up in a patient who received PLUVICTO. In the VISION study, Grade 3 or 4 decreased hemoglobin (15%), decreased platelets (9%), decreased leukocytes (7%), and decreased neutrophils (4.5%) occurred in patients treated with PLUVICTO. Grade ≥ 3 pancytopenia occurred in 1.1% (which includes two fatal events) of patients treated with PLUVICTO. Two deaths (0.4%) occurred due to intracranial hemorrhage and subdural hematoma in association with thrombocytopenia, one death (0.2%) occurred due to sepsis and concurrent neutropenia, and one death (0.2%) occurred due to bone marrow failure. Perform complete blood counts before and during treatment with PLUVICTO. Withhold, reduce dose, or permanently discontinue PLUVICTO based on the severity of myelosuppression .

Renal Toxicity

PLUVICTO can cause severe renal toxicity. In the PSMAfore study, Grade 3 or 4 acute kidney injury (1.3%) occurred in patients treated with PLUVICTO. In the VISION study, Grade 3 or 4 acute kidney injury (3.4%) occurred in patients treated with PLUVICTO. Advise patients to remain well hydrated and to urinate frequently before and after administration of PLUVICTO. Perform kidney function laboratory tests, including serum creatinine and calculated creatinine clearance (CLcr), before and during treatment with PLUVICTO. Withhold, reduce dose, or permanently discontinue PLUVICTO based on the severity of renal toxicity .

Embryo-Fetal Toxicity

The safety and efficacy of PLUVICTO have not been established in females. Based on its mechanism of action, PLUVICTO can cause fetal harm . No animal studies using lutetium Lu 177 vipivotide tetraxetan have been conducted to evaluate its effect on female reproduction and embryo-fetal development; however, radioactive emissions, including those from PLUVICTO, can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception during treatment with PLUVICTO and for 14 weeks after the last dose .

Infertility

PLUVICTO may cause infertility in males. The recommended cumulative dose of

GBq of

PLUVICTO results in a radiation absorbed dose to the testes within the range where PLUVICTO may cause temporary or permanent infertility .

Pregnancy Safety for Pluvicto

Pregnancy Risk Summary The safety and efficacy of PLUVICTO have not been established in females. Based on its mechanism of action, PLUVICTO can cause fetal harm . There are no available data on PLUVICTO use in pregnant females. No animal studies using lutetium Lu 177 vipivotide tetraxetan have been conducted to evaluate its effect on female reproduction and embryo-fetal development; however, all radioactive emissions, including those from PLUVICTO, can cause fetal harm.

Pediatric Use of Pluvicto

Pediatric Use The safety and effectiveness of PLUVICTO in pediatric patients have not been established.

Overdosage Information for Pluvicto

In the event of administration of a radiation overdosage with PLUVICTO, reduce the radiation absorbed dose to the patient by increasing the elimination of the radionuclide from the body by frequent micturition or by forced diuresis and frequent bladder voiding. Estimate the effective radiation dose that was applied and treat with additional supportive care measures as clinically indicated.

Clinical Studies of Pluvicto

PSMA-Positive mCRPC Previously Treated With

ARPI Therapy PSMAfore The efficacy of PLUVICTO was evaluated in PSMAfore (NCT04689828), a randomized (1:1), multicenter, open-label trial that evaluated PLUVICTO (N = 234) versus a change in ARPI (N = 234) in patients with progressive, PSMA-positive mCRPC. Randomization was stratified by setting of prior ARPI use and by symptomatology. Patients were required to have a castrate level of serum/plasma testosterone by either medical castration or prior orchiectomy at study entry. Patients were required to have progressed only once on an ARPI (abiraterone acetate, enzalutamide, darolutamide, or apalutamide). Prior taxane-based chemotherapy was only allowed in the adjuvant or neoadjuvant setting greater than 12 months before enrollment.

Patients were considered appropriate for delay of taxane-based chemotherapy by the investigator. Patients were required to have PSMA-positive mCRPC defined as having at least one tumor lesion (soft tissue or bone) with gallium Ga 68 gozetotide uptake greater than in normal liver. Patients were considered ineligible if any intraprostatic lesion or any one lesion larger than size criteria had gallium Ga 68 gozetotide uptake less than or equal to uptake in normal liver.

Patients received PLUVICTO

GBq (200 mCi) every 6 weeks for 6 doses or a change

in ARPI. Supportive care administered at the investigator’s discretion included bone-targeted agents; androgen deprivation therapy (ADT); or palliative radiotherapy. The median age was 72 years (range, 43 to 94 years); 91% were White; 2.6% Black or African American; 0.6% Asian; 6% were Hispanic or Latino; 99% had ECOG PS0-1. The major efficacy outcome measure was radiographic progression-free survival (rPFS) as determined by blinded independent central review (BICR) per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Additional efficacy outcome measures were Overall Survival (OS) and Overall Response Rate (ORR). PSMAfore demonstrated a statistically significant improvement in rPFS for PLUVICTO compared to a change in ARPI. Of patients that were randomized to receive a change in ARPI, 141 patients (60%) crossed over to receive PLUVICTO after confirmation of radiographic disease progression by BICR. Efficacy results for PSMAfore are presented in Table 9 and Figure 1. Table 9: Efficacy Results in PSMAfore ARPI = androgen receptor pathway inhibitor; NE = Not estimable; NS = Not statistically significant a By BICR per PCWG3-modified RECIST v1.1 criteria. b Excludes one patient in the PLUVICTO arm who was randomized after the data cut-off for the rPFS primary analysis. c Based on Kaplan-Meier estimate. d Hazard ratio based on the stratified Cox PH model. e Stratified log-rank test one-sided p-value. f Responses are based on soft tissue and bone lesion assessment.

PLUVICTO ARPI Radiographic progression-free survival (rPFS) a N = 233 b N = 234 Events (progression or death), n (%) 60 106 Median, months (95% CI) c 9.3 (7, NE)

Hazard ratio (95% CI) d 0.41 P-value e < 0.0001 Overall survival

(OS) N = 234 N = 234 Deaths, n (%) 142 157 Median, months (95% CI) c 24.5

Hazard ratio (95% CI) d 0.91 P-value e NS Overall response rate

(ORR) a,f Patients with measurable disease at baseline N = 72 N = 72 ORR (CR + PR), n (%) (95% CI) 35 10 Complete response (CR), n (%) 15 2 Partial response (PR), n (%) 20 8 Figure 1. Kaplan-Meier Plot of Radiographic Progression-Free Survival in PSMAfore Figure 1. Kaplan-Meier Plot of Radiographic Progression-Free Survival in PSMAfore

PSMA-Positive mCRPC Previously Treated With

ARPI Therapy and Taxane-Based Chemotherapy VISION The efficacy of PLUVICTO was evaluated in VISION (NCT03511664), a randomized (2:1), multicenter, open-label trial of PLUVICTO plus BSoC (N = 551) versus BSoC alone (N = 280) in patients with progressive, PSMA-positive mCRPC. Randomization was stratified by baseline lactase dehydrogenase (LDH ≤ 260 IU/L vs. > 260 IU/L), presence of liver metastases (yes vs. no), ECOG PS score (0 or 1 vs. 2), and inclusion of an AR pathway inhibitor as part of BSoC (yes vs. no) at the time of randomization. Patients were required to have a castrate level of serum/plasma testosterone by either medical castration or prior orchiectomy at study entry. Patients were required to have received at least one ARPI, and 1 or 2 prior taxane-based chemotherapy regimens.

Eligible patients were required to have PSMA-positive mCRPC defined as having at least one tumor lesion (soft tissue or bone) with gallium Ga 68 gozetotide uptake greater than in normal liver. Patients were considered ineligible if any one lesion larger than size criteria had gallium Ga 68 gozetotide uptake less than or equal to uptake in normal liver. Patients received PLUVICTO

GBq (200 mCi) every 6 weeks for up to a total of

6 doses plus BSoC or BSoC alone. BSoC administered at the investigator’s discretion included ketoconazole; radiation therapy to localized prostate cancer targets; bone-targeted agents; ADT; ARPIs. Patients continued treatment for up to 4-6 doses, or until disease progression or unacceptable toxicity.

Patients with stable disease or partial response after 4 doses of PLUVICTO plus BSoC received up to 2 additional doses per investigator’s discretion. The median age was 71 years (range, 40 to 94 years); 87% White; 7% Black or African American; 2.4% Asian; 1.7% were Hispanic or Latino; 92% had ECOG PS0-1; 8% had ECOG PS2. All patients had received at least one prior taxane-based chemotherapy regimen and 41% of patients received two. One prior ARPI had been administered to 51% of patients, 41% of patients had received 2, and 8% of patients had received 3 or more.

During the treatment period, 53% of patients in the PLUVICTO plus BSoC arm and 68% of patients in the BSoC alone arm received at least one ARPI. The major efficacy outcome measures were OS and rPFS as determined by BICR per PCWG3-modified RECIST v1.1 criteria. An additional efficacy outcome measure was ORR. VISION demonstrated a statistically significant improvement in both major efficacy outcome measures of OS and rPFS by BICR with PLUVICTO plus BSoC compared to treatment with BSoC alone. Interpretation of the magnitude of the rPFS effect was limited due to a high degree of censoring from early drop out in the control arm.

Efficacy results for VISION are presented in Table 10 and Figure 2. Table 10: Efficacy Results in VISION a Based on Kaplan-Meier estimate. b Hazard ratio based on the stratified Cox PH model. c Stratified log-rank test two-sided p-value. d Responses are based on soft tissue and bone lesion assessment. e By BICR per PCWG3-modified RECIST v1.1 criteria. f Stratified Wald’s Chi-square test two-sided p-value. PLUVICTO plus BSoC BSoC Overall survival (OS) N = 551 N = 280 Deaths, n (%) 343 187 Median, months (95% CI) a 15.3

Hazard ratio (95% CI) b 0.62 P-value c < 0.001 Overall response

rate (ORR) d,e Patients with measurable disease at baseline N = 184 N = 64 ORR (CR + PR), n (%) (95% CI) 91 1 Complete response (CR), n (%) 17 0 Partial response (PR), n (%) 74 1 P-value f < 0.001 Figure 2. Kaplan-Meier Plot of Overall Survival in VISION Figure 2. Kaplan-Meier Plot of Overall Survival in VISION

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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