TRYbeCA-1

TRYbeCA-1 randomised patients with metastatic pancreatic adenocarcinoma progressing after first-line treatment to eryaspase plus gemcitabine and nab-paclitaxel or irinotecan-based chemotherapy, or chemotherapy alone. The primary endpoint of overall survival was not met when the trial reported in 2021.

Setting

Second-line metastatic pancreatic adenocarcinoma: eryaspase with chemotherapy versus chemotherapy alone

Phase

Phase 3

Sponsor

Erytech Pharma

Registry

NCT03665441

Headline result

Primary overall survival endpoint not met.

Started

2018-09-15

Reported

2021

Enrolled

Outcomes

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In plain words

What these results mean for people, not percentages

Overall survivalprimarysurvival endpoint

Median 7.5 vs 6.7 months with Eryaspase + chemotherapy compared with Chemotherapy alone; about 0.8 months longer for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Put another way, the treated group had about 8 percent lower chance of the event at any given time (hazard ratio 0.92, likely range 0.76 to 1.11).

The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.

Progression-free survivalsurrogate endpoint

Median 3.7 vs 3.4 months with Eryaspase + chemotherapy compared with Chemotherapy alone; about 0.3 months longer for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Put another way, the treated group had about 12 percent lower chance of the event at any given time (hazard ratio 0.88, likely range 0.73 to 1.07).

The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.

Objective response rateresponse endpoint

16.1 vs 12.5 out of 100 had their tumour shrink with Eryaspase + chemotherapy compared with Chemotherapy alone; 3.6 more per 100.
Roughly one extra person helped for every 28 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.

A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.

Caveats

These results apply to the people the trial enrolled: Second-line metastatic pancreatic adenocarcinoma: eryaspase with chemotherapy versus chemotherapy alone. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

Overall survivalprimary

HR 0.92 (0.76 to 1.11) · p = 0.374

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Source

Progression-free survival

HR 0.88 (0.73 to 1.07) · p = 0.196

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Source

Objective response rate

Eryaspase + chemotherapy16.1 of 100

Chemotherapy alone12.5 of 100

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Source

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Overall survivalprimary	Eryaspase + chemotherapy	255	7.5 months	0.92 (0.76 to 1.11)	0.374	link
Overall survivalprimary	Chemotherapy alone	257	6.7 months	0.92 (0.76 to 1.11)	0.374	link
Progression-free survival	Eryaspase + chemotherapy	-	3.7 months	0.88 (0.73 to 1.07)	0.196	link
Progression-free survival	Chemotherapy alone	-	3.4 months	0.88 (0.73 to 1.07)	0.196	link
Objective response rate	Eryaspase + chemotherapy	-	16.1%	-	-	link
Objective response rate	Chemotherapy alone	-	12.5%	-	-	link

Key papers

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rctJournal of Clinical Oncology 20255 citations

TRYBECA-1: A Randomized Phase III Study of Eryaspase Combined With Chemotherapy Versus Chemotherapy as Second-Line Treatment in Patients With Advanced Pancreatic Adenocarcinoma

One trial page on OnCo cites this paper by its DOI; this record gives the citation a page of its own so a reader can follow it without leaving OnCo. Read the abstract above alongside the citing page listed under Related; the record was created automatically from the Europe PMC entry and its figures have not been checked by hand.

Connected

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cancers

Metastatic pancreatic ductal adenocarcinoma Pancreatic ductal adenocarcinoma

technologies

Cytotoxic chemotherapy

drugs

NegativeL-asparaginase encapsulated in donor red blood cells

Eryaspase

ApprovedCytotoxic regimen

Gemcitabine + nab-paclitaxel · Gemzar + Abraxane

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