BioNTech (Nasdaq: BNTX) and OncoC4 reported that the selective T‑reg modulator gotistobart (BNT316/ONC‑392) delivered a clinically meaningful overall‑survival advantage over docetaxel in the non‑pivotal stage of the global Phase 3 PRESERVE‑003 trial in previously treated metastatic squamous non‑small‑cell lung cancer (sqNSCLC).
With a median follow‑up of 14.5 months, median overall survival (OS) for gotistobart was not reached versus 10 months for docetaxel; the 12‑month OS rates were 63.1 % versus 30.3 %. The hazard ratio for death was 0.46 (95 % CI 0.25–0.84) with a nominal p‑value of 0.0102. Safety remained manageable, with grade ≥ 3 treatment‑related adverse events (TRAEs) in 42.2 % of gotistobart patients versus 48.8 % with docetaxel.
Positive
- Median OS not reached at 14.5 months
- 12‑month OS 63.1 % with gotistobart
- Risk of death reduced by 54 % (HR = 0.46)
- Nominal p‑value = 0.0102
- Gotistobart holds FDA Fast Track designation
Negative
- Grade ≥ 3 TRAEs observed in 42.2 % of patients
- Small non‑pivotal cohort: 45 vs 42 patients
- Results from non‑pivotal stage; pivotal stage still ongoing
Key Figures
12‑month OS (gotistobart)
63.1 %
Non‑pivotal stage of PRESERVE‑003 in metastatic sqNSCLC
12‑month OS (docetaxel)
30.3 %
Control arm in PRESERVE‑003
Median OS (docetaxel)
10 months
Non‑pivotal stage of PRESERVE‑003
Patients – gotistobart arm
45
Randomized non‑pivotal stage
Patients – docetaxel arm
42
Randomized non‑pivotal stage
Hazard ratio for OS
0.46 (95 % CI 0.25–0.84)
Gotistobart vs docetaxel
P‑value for OS comparison
0.0102
Nominal p‑value
Grade ≥ 3 TRAEs (gotistobart)
42.2 % (19/45)
Safety profile in non‑pivotal stage
Market Reality Check
$96.25
Last Close
Volume
Volume 1,269,878 is close to the 20‑day average of 1,324,570, indicating no pre‑news volume spike.
normal
Technical
Shares at $96.25 were trading below the 200‑day moving average of $103.78, suggesting a subdued longer‑term trend before this update.
Peers on Argus
Biotech peers moved mixed (INSM –0.33 %, GMAB –1 %, INCY +1.5 %, RPRX +1.48 %, ONC –3.01 %), indicating stock‑specific rather than sector‑wide momentum.
Common Catalyst
GMAB also reported trial data today, reflecting an oncology‑focused news flow rather than a uniform sector move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 03 | Exchange‑offer milestone – minimum condition met with >81 % of CureVac shares tendered | Positive | +0.7 % | Minimum tender condition satisfied |
| Nov 26 | Exchange‑offer timing and ratio disclosed | Positive | +3.0 % | Detailed terms for CureVac share offer |
| Nov 03 | Q3 2025 earnings – higher revenue, strong cash, raised guidance | Positive | +0.0 % | Revenue growth and upgraded full‑year outlook |
| Oct 28 | R&D Day announcement – Innovation Series planned | Neutral | –1.0 % | Strategy and pipeline preview |
| Oct 27 | Q3 2025 earnings date notice | Neutral | +0.4 % | Scheduled results release and conference call |
Corporate and financial announcements have historically generated modest, mostly positive price reactions, suggesting the stock tracks fundamentally positive news.
BioNTech has posted several milestones in recent months. In Q3 2025, the firm reported €1.52 billion in revenue, a year‑to‑date total of €1.96 billion, and raised full‑year guidance to €2.6–2.8 billion, while receiving a $1.5 billion payment from Bristol Myers Squibb. Simultaneously, the CureVac exchange offer reached its minimum tender condition on Dec 3 2025. These developments set a solid financial backdrop for today’s lung‑cancer data.
Market Pulse Summary
Gotistobart’s non‑pivotal Phase 3 results show a 63.1 % 12‑month overall‑survival rate and a 54 % reduction in risk of death versus docetaxel, with a manageable safety profile. The data reinforce BioNTech’s strategic shift from COVID‑19 revenues toward oncology. Investors will be watching the pivotal PRESERVE‑003 cohort—targeting roughly 500 patients—for confirmatory efficacy and subsequent regulatory interactions.
Key Terms
overall survival
medical
Overall survival (OS) measures the length of time patients remain alive after starting treatment, irrespective of cause of death. It is a hard clinical endpoint that drives regulatory approval and market adoption.
median overall survival
medical
The median OS is the point at which half of the patients have died and half remain alive, providing a clear benchmark for treatment efficacy.
phase 3 trial
medical
A Phase 3 trial is a large, late‑stage study designed to confirm efficacy and safety before regulatory filing. Success typically paves the way for market approval.
fast track designation
regulatory
Fast Track status accelerates FDA review for therapies addressing unmet medical needs, potentially shortening time to market.
CTLA‑4
medical
CTLA‑4 is an immune‑checkpoint protein that down‑regulates T‑cell activation. Inhibiting CTLA‑4 can boost anti‑tumor immunity but may increase immune‑related toxicity.
regulatory T cell
medical
Regulatory T cells (Tregs) suppress immune responses and are often enriched within tumors. Selectively depleting tumor‑infiltrating Tregs can enhance anti‑cancer immunity while sparing peripheral tolerance.
hazard ratio
medical
The hazard ratio compares the risk of an event (e.g., death) between two arms over time. A value below 1 indicates risk reduction for the experimental therapy.
FAQ
What did BioNTech and OncoC4 announce about gotistobart on December 6 2025?
They presented non‑pivotal Phase 3 PRESERVE‑003 data showing that gotistobart improved overall survival versus docetaxel in previously treated metastatic squamous NSCLC.
How much did gotistobart reduce the risk of death in the trial?
Gotistobart reduced the risk of death by 54 % (hazard ratio = 0.46, 95 % CI 0.25–0.84; nominal p = 0.0102).
What were the 12‑month overall‑survival rates for gotistobart versus docetaxel?
12‑month OS was 63.1 % with gotistobart compared with 30.3 % for docetaxel.
What safety outcomes were reported for gotistobart?
Grade ≥ 3 treatment‑related adverse events occurred in 42.2 % of gotistobart patients versus 48.8 % with docetaxel; the overall safety profile was described as manageable.
Is gotistobart eligible for expedited review pathways in the United States?
Yes, it received FDA Fast Track designation for metastatic NSCLC after progression on anti‑PD‑(L)1 therapy.
How large was the non‑pivotal cohort in the PRESERVE‑003 announcement?
The non‑pivotal stage randomized 87 patients: 45 to gotistobart and 42 to docetaxel, with data cut‑off on August 8 2025.
Original article, Author: Jam. If you wish to reprint this article, please indicate the source:https://aicnbc.com/14157.html
