Sample benchmark sheet · Oncology
Previously treated, biomarker-selected NSCLC: ORR in single-arm trials
What published trials showed in this setting. This is precedent, not an FDA requirement.
- Indication
- Non-Small Cell Lung Cancer
- Endpoint
- Objective response rate (ORR)
- Setting
- Previously treated, biomarker-selected
- Checked
- 2 November 2026
Lowest approved precedent
37.1%
Objective response rate, with no control arm
CodeBreaK 100 (sotorasib): 46 of 124 patients
The weakest result among the approved trials on this sheet. Approved precedents listed here showed ORR of 37.1% to 64% in pretreated patients, with median DoR of 8.5 to 17.5 months. Observed precedent, not an FDA bar: FDA's NSCLC endpoints guidance treats ORR alone as reasonably likely to predict benefit only when the effect is large and responses are durable.
The trials
Each of these trials supported an FDA approval.
| Trial | Result | Sources |
|---|---|---|
| GEOMETRY mono-1capmatinib, METex14 | 41% (1-2 prior lines); 68% (treatment-naive cohort, outside this 2L row)Figures from: Paper abstract | Wolf et al., NEJM 2020 |
| LIBRETTO-001selpercatinib, RET fusion | 64% in pretreatedFigures from: Paper abstract | Drilon et al., NEJM 2020 |
| CodeBreaK 100sotorasib, KRAS G12C | 37.1%Figures from: Paper abstract | Skoulidis et al., NEJM 2021 Lumakras FDA label |
| KRYSTAL-1adagrasib, KRAS G12C | 42.9%Figures from: Paper abstract | Jänne et al., NEJM 2022 |
Results are objective response rates.
Observed range: 37.1% to 64%, median 41.95%. Based on the 4 named trials listed. Range and median use each trial's pretreated cohort.
The limits of this sheet
- These are single-arm results, so there is no control arm to measure a gain against.
- Each drug treats a different group: MET exon 14, RET fusion or KRAS G12C. A rate in one group does not carry over to another or to an unselected population.
- Duration counted as well as rate. Median duration of response ran from 8.5 to 17.5 months here.
- Prior treatment differs. GEOMETRY mono-1 counted one or two prior lines, while 81.0% of CodeBreaK 100 patients and 98.3% of KRYSTAL-1 patients had received both chemotherapy and immunotherapy.
- Sotorasib and adagrasib are still on FDA's accelerated approval list.
- Papers and labels can differ. Sotorasib's FDA label gives 36% and a 10-month median duration of response from the same study, which would lower this precedent.
- This is precedent, not a requirement. These results supported approvals in their own context, and matching a number here guarantees nothing.
- This is a selected list. Only the trials named here are counted, and other approvals in this setting are not on this sheet.
- Results across trials are not directly comparable. Populations, control arms, follow-up and response criteria differ.
FDA context
All four listed drugs first reached the market through accelerated approval on ORR and DoR: capmatinib 5/6/2020 and selpercatinib 5/8/2020 (both since converted to traditional approval), sotorasib 5/28/2021 and adagrasib 12/12/2022 (still accelerated). FDA lists: fda.gov and fda.gov. FDA's NSCLC endpoints guidance: fda.gov.
How this was checked
On 2 November 2026 automated tools checked each result against the source named beside it and resolved each paper’s DOI. No clinician has reviewed this sheet. Check the source before you rely on a figure. Tell us if something looks wrong.
Look up an indication you know well
This is a sample. The app has the rest of our benchmark library, which is mostly oncology, and tracks changes to the ClinicalTrials.gov records of the programs you watch. It is free during early access, with no card needed.