Data Readout

CG Oncology's PIVOT-006 data slip past H1 2026 guidance

The Phase 3 readout in intermediate-risk bladder cancer has not posted despite four rounds of sponsor guidance for H1 2026, even as the trial's own completion date moved to November.

By AppliedXLJanuary 9, 2026Trial NCT06111235

Executive Summary

CG Oncology's Phase 3 trial testing adjuvant cretostimogene grenadenorepvec against surveillance in intermediate-risk bladder cancer has not delivered the topline data the company told investors to expect by mid-2026.
The trial's own registered primary completion date shifted from June to November 2026 after the company had already guided to a first-half readout, a timing gap that now sits unresolved.
The trial is the first randomized registrational study in this specific intermediate-risk population, where no therapy currently carries FDA approval for adjuvant use, so the result will define whether cretostimogene's efficacy extends beyond the high-risk setting where it is furthest along.
Cretostimogene has no other oncolytic virus tested in a comparably designed Phase 3 trial for this indication, and the nearest signal available is the sponsor's own related-indication study, so the readout will be judged largely against the company's own prior result rather than a rival's.

The guidance and the gap

CG Oncology said on January 9, 2026 that PIVOT-006 topline data was expected in the first half of 2026, nearly a year ahead of the timeline it had previously set, citing rapid enrollment across more than 90 sites. The company repeated that guidance in filings and events on January 12, February 27, and May 8, 2026, each time pointing to the same January-through-June window. That window closed June 30, 2026, and no result has posted. The trial's own registry record shows its primary completion date moved from June 1, 2026 to November 1, 2026 as of July 1, 2026, a change logged after three of the four guidance restatements. CG+1

Probability of Success

Endpoint Met75%

Completes82%

Clinical Significance38%

Regulatory85%

What the trial tests

PIVOT-006 is a randomized, open-label, two-arm Phase 3 study comparing intravesical cretostimogene against surveillance in 367 adults with intermediate-risk disease following tumor resection. Its primary endpoint is recurrence-free survival at 12 and 24 months, an efficacy measure, not a safety or dose-finding readout. CG Oncology called it the first randomized trial to test an investigational therapy in this population, covering the broadest range of intermediate-risk patients under AUA/SUO guidelines, including solitary high-grade Ta lesions under 3 centimeters. Chairman and CEO Arthur Kuan said the company sees an opportunity in a population estimated at more than 50,000 patients in the US with no FDA-approved adjuvant option. NCT06111235+1

Enrollment and trial operations

The trial completed enrollment at 367 patients, matching its final target after an earlier anticipated count of 426 was revised down to 364 in 2024 and then adjusted to 367 in September 2025 when the study moved to Active, not recruiting. That enrollment path sits within the routine range for a trial of this design, since the operational model flags enrollment swings only at 20% or more, and this trial's final count matches its own target with no net change. The primary completion date has moved twice since the trial began, most recently pushing five months past the sponsor's own guided readout window. NCT06111235

The competitive frame

Cretostimogene's closest comparator is CG Oncology's own BOND-003 trial, a Phase 3 study of the same drug in the related high-risk, BCG-unresponsive NMIBC population, which reported a 41.8% complete response rate at 24 months with no Grade 3 or higher treatment-related adverse events. No other oncolytic virus program has reached Phase 3 in a trial sharing cretostimogene's RB1 pathway target and NMIBC indication; the wider field around this indication is populated instead by different mechanisms, including antibody-drug conjugates and radiopharmaceuticals tested in other genitourinary cancers, none of which shares cretostimogene's modality or target in this setting. Because no FDA-approved therapy exists for adjuvant treatment of this intermediate-risk population, the bar for PIVOT-006 is not separation from an active comparator, it is whether recurrence-free survival against surveillance alone is large enough and durable enough to support a filing. NCT06111235

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.