BioNTech shows off lung cancer survival data behind phase 3 push for red-hot bispecific

BioNTech's BNT327 Shows Promising Survival Data in Lung Cancer Trial

BioNTech's bispecific antibody BNT327 demonstrated a median overall survival of 16.8 months in a Chinese phase 2 trial for small cell lung cancer (SCLC)13.
72.7% of patients treated with BNT327 were alive after 12 months3.
The drug candidate targets both PD-L1 and VEGF-A pathways3.
BioNTech is advancing BNT327 to global phase 3 trials in first-line SCLC and non-small cell lung cancer (NSCLC)6.

## Trial Details and Results:

The phase 2 trial enrolled 50 patients with extensive-stage SCLC. BNT327 was given as a first-line treatment in combination with chemotherapy and platinum3. Key findings include:

85.4% of evaluable patients had a confirmed objective response rate3.
Disease control rate was 97.9%3.
Median progression-free survival was 6.9 months3.

## Comparison to Existing Treatments:

BNT327's median overall survival of 16.8 months compares favorably to current standards of care:

Tecentriq plus chemotherapy:
12.3 months median OS1

Imfinzi:
13 months median OS1

## Safety Profile:

The trial recorded treatment-related adverse events in all patients, with 86% experiencing severe side effects. However, events of special interest were less problematic, including hypertension, proteinuria, and hemorrhage3.

## Future Development:

BioNTech is initiating global phase 3 trials for BNT327:

First-line SCLC:
Comparing BNT327 plus chemotherapy to Tecentriq plus chemotherapy6

First-line NSCLC:
Design similar to Summit's ivonescimab trial, but without PD-L1 expression requirements6

Additionally, BioNTech plans to start a phase 3 trial in triple-negative breast cancer6.

## Market Impact:

BNT327 is part of a new class of cancer therapies targeting both PD-1 and VEGF pathways. This approach gained attention after Akeso and Summit Therapeutics' ivonescimab outperformed Keytruda in a phase 3 NSCLC study3. BioNTech's promising data positions them as a strong competitor in this emerging field of bispecific antibodies for cancer treatment.

Sources:

1. https://www.fiercebiotech.com/biotech/biontech-shows-lung-cancer-survival-data-behind-phase-3-push-red-hot-bispecific

3. https://www.biospace.com/drug-development/biontechs-bispecific-elicits-treatment-response-in-majority-of-sclc-patients

6. https://www.oncologypipeline.com/apexonco/biontechs-pivotal-bispecifics-plan-take-shape

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