FDA issues reminder to sponsors: Disclose clinical trial results

Cercek: “The majority of patients in AZUR-1 in a global study were able to avoid all of standard of care”

On Oct. 19, FDA granted an accelerated approval to dostarlimab-gxly (Jemperli) for the treatment of patients with previously untreated stage 2 or stage 3 rectal cancer that is mismatch repair deficient or microsatellite instability–high, as determined by an FDA-authorized test.

November 04, 2026

Clinical

MSK’s Andrea Cercek: Oncology faces learning curve as dostarlimab challenges dMMR rectal cancer standard of care

Earlier this week, FDA granted an accelerated approval to dostarlimab-gxly (Jemperli), for adults with previously untreated stage 2 or stage 3 rectal cancer that is mismatch repair deficient or microsatellite instability-high, marking a celebratory moment for the field.

Tarlatamab + durvalumab extend median OS for patients with ES-SCLC, phase III DeLLphi-305 trial finds

In patients with extensive-stage small cell lung cancer, tarlatamab, a bispecific T-cell engager, plus durvalumab as first-line maintenance therapy extended median overall survival by more than eight months, more than tripled progression-free survival, and reduced the risk of death by 58% compared to durvalumab alone, according to results of the phase III open-label, multicenter, randomized DeLLphi-305 study.

October 30, 2026

Vol.52 No.40

Clinical Roundup

Divarasib monotherapy improves OS in previously-treated KRAS G12C-mutated lung cancer, phase III trial finds

Divarasib, a next-generation KRAS G12C inhibitor, lowered the risk of disease progression or death by 42% and the overall risk of death by 44% in people with previously treated KRAS G12C-mutated non-small cell lung cancer, according to the results from the phase III Krascendo 1 study. The therapy demonstrated the superior efficacy compared with current standard of care KRAS G12C inhibitors.

October 30, 2026

Vol.52 No.40

Clinical Roundup

Arcotatug tavatecan improves OS and PFS in patients with advanced gastric cancer, phase III study finds

The phase III G-HOPE-001 study (NCT06238843), evaluating arcotatug tavatecan (TAK-921 or IBI343) in patients with Claudin 18.2-positive, previously treated, advanced gastric or gastroesophageal junction adenocarcinoma, met its dual primary endpoints of overall survival and progression-free survival.

October 30, 2026

Vol.52 No.40

Clinical Roundup

Perioperative Imfinzi + Padcev improves EFS, OS, in MIBC, phase III trial finds

Perioperative Imfinzi (durvalumab) plus neoadjuvant Padcev (enfortumab vedotin) reduced risk of recurrence by 49% and risk of death by 42% in muscle-invasive bladder cancer, according to the VOLGA phase III trial. The combination demonstrated statistically significant and clinically meaningful improvements in the primary endpoint of event-free survival and key secondary endpoint of overall survival in patients with muscle-invasive bladder cancer versus standard of care.

October 30, 2026

Vol.52 No.40

FDA issues reminder to sponsors: Disclose clinical trial results

YOU MAY BE INTERESTED IN

Cercek: “The majority of patients in AZUR-1 in a global study were able to avoid all of standard of care”

MSK’s Andrea Cercek: Oncology faces learning curve as dostarlimab challenges dMMR rectal cancer standard of care

Tarlatamab + durvalumab extend median OS for patients with ES-SCLC, phase III DeLLphi-305 trial finds

Divarasib monotherapy improves OS in previously-treated KRAS G12C-mutated lung cancer, phase III trial finds

Arcotatug tavatecan improves OS and PFS in patients with advanced gastric cancer, phase III study finds

Perioperative Imfinzi + Padcev improves EFS, OS, in MIBC, phase III trial finds

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