FDA record · Cancer
What FDA's own documents say about Penpulimab-kcqx: what it is approved for, the trials FDA reviewed, the results it reported and the risks on the label.
“Penpulimab-kcqx is a programmed death receptor-1 (PD-1)-blocking antibody indicated:”
Prescribing information, supplement 002 · PDF p. 1 · fda.gov ↗
| Trial | ClinicalTrials.gov | Phase | Mentions | Documents |
|---|---|---|---|---|
| JUPITER-02 | not given | 8 | 1 of 14 | |
| POLARIS-02 | not given | 7 | 1 of 14 |
Mentions: how many sentences across the FDA documents name the trial. NCT ids are read from the documents or, where they give none, matched on ClinicalTrials.gov by the trial's name or protocol code.
Sentences from FDA's reviews that give an endpoint's p-value, effect or confidence interval, those reporting a treatment effect first.
PFS
“At an interim analysis of PFS based on 189 events (85% information fraction [IF]), the trial demonstrated a statistically significant and clinically meaningful improvement in BICR-assessed PFS favoring the penpulimab arm, with a hazard ratio (HR) of 0.45 (95% CI 0.33, 0.62, p-value <0.0001), corresp”
Multi-disciplinary Review · PDF p. 17 · fda.gov ↗
85%95%p-value <0.0001
PFS
“As of DCO date for this interim analysis, compared with placebo group, a significant benefit in terms of PFS was demonstrated in AK105 group (P<0.0001), which reduced the risk of PD or death by 55% (HR=0.45, 95% CI: 0.33, 0.62), which is numerically better than the other PD-1 inhibitors (with the ca”
Multi-disciplinary Review · PDF p. 108 · fda.gov ↗
P<0.000195%55%
overall survival
“A statistically significant OS improvement was also observed with median OS not reached (95% CI: 38.7 months, not estimable) for the toripalimab-tpzi-containing regimen and 33.7 months (95% CI: 27.0, 44.2) for the placebo-containing regimen (HR 0.63 [95% CI: 0.45, 0.89], p-value=0.0083).”
Multi-disciplinary Review · PDF p. 32 · fda.gov ↗
95%p-value=0.0083
overall survival
“OS not reached (95% CI: 38.7 months, not estimable) for the toripalimab-tpzi-containing regimen and 33.7 months (95% CI: 27.0, 44.2) for the placebo-containing regimen (HR 0.63 [95% CI: 0.45, 0.89], p-value=0.0083).”
Multi-disciplinary Review · PDF p. 297 · fda.gov ↗
95%p-value=0.0083
ORR
“Penpulimab Cavg,ss and ORR (p <0.05).”
Multi-disciplinary Review · PDF p. 230 · fda.gov ↗
p <0.05
“Penpulimab-kcqx in combination with either cisplatin or carboplatin and gemcitabine: The most common adverse reactions (>=20%) were nausea, vomiting, hypothyroidism, constipation, decreased appetite, decreased weight, cough, COVID-19 infection, fatigue, rash, and pyrexia.”
Prescribing information, supplement 002 · PDF p. 1 · fda.gov ↗
“Penpulimab-kcqx exposure increased dose proportionally over the dose range of 1 to 10 mg/kg (0.35 to 3.5 times the approved recommended dosage in a 70 kg patient) after the first dose.”
Prescribing information, supplement 002 · PDF p. 17 · fda.gov ↗
| Document | Date | Pages | Copy | sha256 |
|---|---|---|---|---|
| Prescribing information, original approval (corrected)761258Orig1s000correctedlbl.pdf | April 24, 2025 | 29 | 03a642f64b83 | |
| Approval letter (corrected)761258Orig1s000correctedltr.pdf | May 1, 2025 | 8 | 886387d7f214 | |
| Administrative Correspondence761258Orig1s000AdminCorres.pdf | May 21, 2025 | 42 | b106fc078aa0 | |
| Approval Letter761258Orig1s000Approv.pdf | May 21, 2025 | 11 | 5ebfc7000b54 | |
| Chemistry Review761258Orig1s000ChemR.pdf | May 21, 2025 | 57 | 4bcdabda1266 | |
| Prescribing Information (Label)761258Orig1s000Lbl.pdf | May 21, 2025 | 30 | a4c42df48cd7 | |
| Multi-disciplinary Review761258Orig1s000MultidisciplineR.pdf | May 21, 2025 | 449 | 40fb0745f7c4 | |
| Proprietary Name Review761258Orig1s000NameR.pdf | May 21, 2025 | 11 | fecb56bddfc7 | |
| Officer/Employee List761258Orig1s000OEList.pdf | May 21, 2025 | 2 | e3081cad3ed5 | |
| Other Action Letters761258Orig1s000OtherActionLtrs.pdf | May 21, 2025 | 9 | cb86f790ba26 | |
| Other Reviews761258Orig1s000OtherR.pdf | May 21, 2025 | 72 | 8846aa1895cc | |
| Risk Assessment / REMS Review761258Orig1s000RiskR.pdf | May 21, 2025 | 15 | a696c9bde573 | |
| Prescribing information, supplement 002761258s002lbl.pdf | September 1, 2026 | 23 | 739293a92b28 | |
| Approval letter, supplement 002761258Orig1s002ltr.pdf | September 2, 2026 | 4 | 97cd50cd6c96 |
Checked against FDA's copies on September 30, 2026. The sha256 is the fingerprint of the file that was read: download it from fda.gov and compare. Quotes come from the text of each file as read; pages FDA stored as images were read by OCR and are marked.
Generated automatically (auto): the trials, names and dates are drafted from the documents by rules, with no language model; see the method.