4
Indication details
- Combined Agent(s)
- Oxaliplatin + Leucovorin + Fluorouracil (mFOLFOX6)
- Control Arm
- Placebo + mFOLFOX6
- Therapeutic Indication
- Zolbetuximab, a claudin 18.2 (CLDN18.2)-directed cytolytic antibody, with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2 positive.
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Gastric or gastroesophageal junction adenocarcinoma
- Tumour Stage
- Locally advanced unresectable or metastatic
- Tumour Sub-Group
- HER2-negative, CLDN18.2 positive
- Trial Name
- SPOTLIGHT
- NCT Number
- NCT03504397
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval October 2024
Primary Outcome(s)
- Primary Outcome(s)
- PFS. OS as secondary endpoint
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 8.7 months
- PFS Gain
- 1.9 months
- PFS HR
- 0.75 (0.60 - 0.94) p=0.0066
- OS Control
- 15.5 months
- OS Gain
- 2.7 months. 12% at 3 years with only 3.2% on follow-up at the experimental arm
- OS HR
- 0.75 (0.60 - 0.94) p=0.0053 (interim OS analysis, met the prespecified threshold of 0.0135)
Adjustments
- QoL Comment
-
Reviewed, but not qualified for an ESMO-MCBS credit
- Toxicity Comment
-
>10% increment in discontinuation due to adverse effects, 10% increase Gr3+ Nausea and vomiting
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 467
- Scorecard version
- 1
- Issue date
- 07.11.2024
- Last update
- 04.12.2024
Legend
Information about symbols, abbrevations and color codes
Red = negative
Green = positive
Grey = neutral
?
Grey + ? = neutral with pending data
- DFS
- Disease-Free Survival
- DoR
- Duration of Response
- EFS
- Event-Free Survival
- HR
- Hazard Ratio
- NEB
- No evaluable benefit
- NI
- Non-inferiority Study
- ORR
- Overall Response Rate
- OS
- Overall Surival
- pCR
- Pathological Complete Response/Remission
- PFS
- Progression-Free Survival
- QoL
- Quality of Life
- RFS
- Relapse-Free Survival
- RR
- Response Rate
QoL adjustments
Other adjustments*
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
QoL adjustments
Red = negative / deterioration
Green = positive / improvement
Other adjustments*
Red = negative / deterioration
Green = positive / improvement
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
* Other adjustments include:
- Long-term plateau in the survival curve
- Long-term plateau in the PFS curve
- Early stopping or crossover
- Only improved PFS mature data shows no OS advantage and no improved Qol.