Major results of Phase III VISION trial announced


Earlier today, Novartis issued a media release giving the major results of the Phase III VISION trial, which compared the effectiveness of 177Lu-PSMA-617+ best standard of care (SOC), as selected by individual investigators, to SOC alone in the treatment of men with PSMA-positive men with metastatic, castration-resistant prostate cancer (mCRPC). The results of this trial are scheduled for presentation on June 6, at the 2021 annual meeting of the American Society of Clinical Oncology (ASCO).

The basic results of this trial, as itemized in the media release, as as follows:

  • All patients enrolled into the trial had to have had a positive results showing the expression of PSMA
  • Median overall survival was
    • 15.5 months for men in the 177Lu-PSMA-617 + best SOC arm (n = 551)
    • 11.3 months for men in the best SOC arm (n = 280)
  • Median radiographic progression-free survival (rPFS) was
    • 8.7 months for men in the 177Lu-PSMA-617 + best SOC arm
    • 3.4 months for men in the best SOC arm1.

These data imply that there was

  • A 38 percent reduction in risk for death from any cause for men in the 177Lu-PSMA-617 + best SOC arm compared to the best SOC arm (hazard ratio [HR] = 0.62)
  • A 60 percent reduction in risk for rPFS or death from any cause for men in the 177Lu-PSMA-617 + best SOC arm compared to the best SOC arm (HR = 0.40)

However, it should be noted that Grade ≥3 drug-related treatment emergent adverse events (TEAEs) occurred in

  • 28.4 percent of men treated in the 177Lu-PSMA-617 + best SOC
  • 3.9 percent of men treated in the best SOC arm

The most common TEAEs were anemia (12.9 vs. 4.9 percent), thrombocytopenia (7.9 vs. 1 percet), lymphopenia (7.8 vs. 0.5 pecent), fatigue (5.9 vs. 1.5 percent),  urinary tract infection (3.8 vs 0.5 percent), neutropenia (3.4 vs 0.5 percent), hypertension (3.2 vs 1.5 percent), back pain (3.2 vs. 3.4 percent), acute kidney injury (3.0 vs 2.4 percent), leukopenia (2.5 vs. 0.5 percent), bone pain (2.5 vs. 2.4 percent), hematuria (2.5 vs 0.5 percent), and spinal cord compression (1.3 vs. 5.4 percent).

The bottom line to these data — as reported by Novartis — are therefore that there was a 4.2-month increase in median overall survival for men treated with 177Lu-PSMA-617 + best SOC, but this survival benefit came with a significant increase in risk for TEAEs of Grade 3 or higher.

Rates of treatment discontinuation associated with TEAEs occurred as follows:

  • 11.9 percent of men treated with the 177Lu-PSMA-617 + SOC arm discontinued 177Lu-PSMA-617
  • 8.5 percent of men treated with the 177Lu-PSMA-617 + SOC arm discontinued SOC
  • 7.8 percent of men treated with the best SOC arm discontinued SOC

It is estimated that approximately 80 percent of all men with mCRPC are positive for expression of PSMA and would be eligible for treatment with 177Lu-PSMA-617 + best SOC should thsi drug be approved for treatment by US and other regulatory bodies such as the Food and Drug Administration (FDA).

One Response

  1. Note that the full results from the VISION trial have now been published (by Sartor et al.) in the New England Journal of Medicine.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.

%d bloggers like this: