Target product profile

Minimum and target reset row by row against the approved drug and every competing program, with where phase 1 data lands. Each benchmark on its own population

Customize this Agent

DOCXXLSX15 steps

The problem

The TPP's survival floor beat chemotherapy's 6.7 months. Rasonque was approved on 13.2

A pancreatic TPP last revised before April set its overall survival floor against second line chemotherapy, which ran 6.7 months in the RASolute 302 control arm. Rasonque reached 13.2 months, a hazard ratio of 0.40, and was approved August 26. A floor that only beats chemotherapy is now below an approved drug, and RASolute 302 reports its RAS G12 and overall populations separately

The request

RASolute 302 and Rasonque's August 26 approval moved every efficacy row in our Project Saffron TPP. Saffron is our oral KRAS G12D selective inhibitor finishing phase 1 dose expansion. Rewrite the profile for second line metastatic pancreatic cancer before the phase 2 decision: minimum acceptable and target for indication and population, biomarker test, OS, PFS, ORR, safety and discontinuation, dosing and line of therapy. Benchmark each row against Rasonque's label and RASolute 302 and every RAS or KRAS G12D program with pancreatic data, each figure on the population it was reported for. Mark where our latest phase 1 cut clears each bar. I need the TPP and a benchmark workbook; version 3 and the data cut are attached.

Saffron TPP v3 March 2026.docx
Saffron phase 1 data cut Aug 2026.pdf

How Axe works

ApprovedChanges asked

Your reviewApprove, or say what to change

Approved or changes

Profile and benchmark workbookProfile, workbook and QC log

Final reviewApprove the revised files

Revised profile and benchmark workbookRevised files and QC log

Step

Match the population basis

Prompt

Sent to the model at this step

Put every benchmark on the basis Saffron will be judged on: metastatic pancreatic adenocarcinoma, KRAS G12D, one prior line of systemic therapy. Build the benchmark workbook with one row per program, endpoint and population, and columns for the figure, its 95% confidence interval, number of patients, population, mutation, line and prior therapy, endpoint definition, assessment (blinded central review or investigator), confirmed or unconfirmed response, data cutoff, median follow up, design (randomized or single arm) and source. For Rasonque, use the G12D subgroup where the paper, appendix or label reports it; otherwise use the RAS G12 population and mark it as the nearest basis, and keep the overall population on its own row. Keep hazard ratios and medians from the randomized comparison apart from single arm medians, and state every time endpoint in months. Where a competitor reports a cohort pooled across lines or mutations, keep it and mark the mismatch; where it reports a second line G12D cohort, rank that row first. Never put a figure from one population beside a figure from another in the same row. Add a Basis tab naming, for each attribute in the request, the benchmark row that will set its bar and why that row is the closest match.

Uses

Asset
Current rows
Approved benchmark
Competing programs

Produces

Benchmark workbook

What you get back

DOCXTarget product profileWhat moved, attribute table with minimum, target, benchmarks and phase 1, rationale, changes

XLSXBenchmark workbookBenchmarks by program, endpoint and population, Rasonque by population, basis, bars, phase 1, changes

QC logOpen items first, then each figure marked checked or corrected, with its source

Make it yours

Point it at your asset and indication, change the rows or the competitor cutoff, or use your house TPP template. Every step and every prompt can be edited

Customize this Agent

Opens a private copy of this Agent in your workspace, ready to adapt to your own sources

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