Colon Cancer Immunotherapy Approved; New Data in Parkinson's and Glioblastoma

The week brought a landmark colorectal cancer approval, two significant neurological trial readouts, encouraging broad-spectrum vaccine data, and a policy shift in how the United States plans to run clinical trials.

Thursday, 8 October: FDA Approves Tecentriq for High-Risk Stage III Colon Cancer

The US Food and Drug Administration approved atezolizumab (Tecentriq, Genentech/Roche) in combination with FOLFOX6 chemotherapy as adjuvant treatment for adults with stage III deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H) colon cancer following surgery — the first approval of a checkpoint immunotherapy in this setting.

The decision rests on the Phase 3 ATOMIC trial, which randomised 712 patients to FOLFOX6 alone or FOLFOX6 plus Tecentriq for 12 cycles followed by 13 cycles of Tecentriq monotherapy. Three-year disease-free survival reached 86% with the combination versus 76% with chemotherapy alone — a 50% reduction in the risk of recurrence or death. About 15% of stage III colon cancers carry the dMMR or MSI-H biomarker, making them particularly responsive to checkpoint immunotherapy. Roche is also pursuing approval through the European Medicines Agency, which would extend access to patients across the EU.

Thursday, 8 October: Parkinson's Drug Solengepras Meets Phase 3 Primary Endpoint

Cerevance reported that solengepras 150 mg daily met the primary endpoint in the Phase 3 ARISE trial in Parkinson's disease. Among 341 participants already on levodopa-based therapy who still experienced motor fluctuations, the 150 mg dose reduced total daily "off" time by 0.61 hours relative to placebo over 12 weeks, and added roughly 0.6 hours of "on" time per day.

Solengepras is a GPR6 antagonist — it blocks an adenosine receptor in the striatum that modulates dopamine signalling, a mechanism distinct from all existing dopaminergic add-on therapies. The drug was well tolerated; no patient in the 150 mg group experienced a serious adverse event. Cerevance plans to seek FDA guidance on a New Drug Application pathway. These are company-reported topline results; full peer-reviewed data are awaited.

Wednesday, 7 October: Glioblastoma Vaccine Shows Signal in Younger Patients but Misses Primary Endpoint

The Phase IIb SURVIVE trial of SurVaxM — a peptide vaccine targeting the survivin protein expressed on glioblastoma cells — reported mixed results in 233 evaluable patients with newly diagnosed glioblastoma. Adding SurVaxM to standard radiotherapy and temozolomide did not reach statistical significance for overall survival in the full population: median survival was 22.8 months with the vaccine versus 20.3 months with placebo (HR 0.75; 95% CI 0.54–1.03; P = .076).

A prespecified subgroup of patients aged 65 years or younger did show a significant overall survival benefit. Grade 3 or higher adverse events were similar in both arms (48% vs 46%); no treatment-related deaths were reported. Glioblastoma remains one of the deadliest cancers, with very few approved therapies. The younger-patient finding is hypothesis-generating rather than practice-changing at this stage; MimiVax plans to seek FDA breakthrough therapy designation based on those data. Full peer-reviewed publication has not yet appeared.

Monday, 5 October: 31-Valent Pneumococcal Vaccine Clears Phase 3 in Adults

Vaxcyte reported positive topline results from OPUS-1, the Phase 3 immunogenicity trial of VAX-31, its 31-valent pneumococcal conjugate vaccine, enrolling 4,047 adults aged 18 and older. VAX-31 met co-primary non-inferiority endpoints against PCV20 and PCV21 for the 28 serotypes those vaccines share with VAX-31, and demonstrated superiority on three unique serotypes plus cross-reactive serotype 20B. Two serotypes (3 and 12F) fell short of the strictest non-inferiority threshold against PCV21 but met a historical secondary benchmark.

Current standard-of-care vaccines cover 20 or 21 pneumococcal serotypes. Streptococcus pneumoniae causes a significant burden of pneumonia, meningitis, and bacteraemia, particularly in older adults. A 31-valent vaccine could meaningfully expand protection in communities where pneumococcal disease remains a public-health concern, including among elderly populations in Cyprus and the wider eastern Mediterranean. Vaxcyte plans to submit a Biologics License Application in the first half of 2028, pending results from the ongoing OPUS-2 and OPUS-3 trials expected in early 2027.

Wednesday–Thursday, 30 September–1 October: US Launches SURPASS to Redesign Clinical Trials with AI

The US Department of Health and Human Services and its Advanced Research Projects Agency for Health (ARPA-H) launched SURPASS, a programme aimed at rebuilding clinical trial infrastructure using artificial intelligence and adaptive platform designs. SURPASS targets three layers of trial architecture: a phaseless design engine that uses digital twins and predictive models to simulate outcomes — enabling faster, smaller, regulation-compliant trials; a continuous inference engine that analyses incoming data in real time and supports adaptive protocol modifications; and an agentic AI operations layer to automate site activation, document handling, and data collection.

Three companion initiatives were announced alongside SURPASS, including STACK, which aims to expand the number of qualified US trial sites. Award recipients will receive five-year funding; solution summaries from applicants are due 30 November 2026.

This programme is distinct from AI tools that run virtual or in-silico trials using synthetic patients — SURPASS redesigns the statistical and operational scaffolding around human-participant trials. Faster, more adaptive trials could lower development costs and widen the range of conditions that attract adequately powered research.

This article is intended for general informational purposes only and does not constitute medical advice. Readers should consult a qualified healthcare professional before making any changes to their treatment or health management.