FDA to remove black box warnings on hormone therapy for menopause Trump-era “gold standard science” is not to be confused with gold standard of scientific evidence

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.

HHS announces initiative to improve breast cancer screening and early detection

HHS, through the recently announced Office of Women’s Health, announced taht it will be pursuing a collaboration with the Agency for Healthcare Research and Quality and DenseBreast-info.org to strengthen breast cancer screening, expand breast density education, and improve timely diagnostic follow-up, particularly for midlife women.

October 30, 2026

Vol.52 No.40

By Claire Marie Porter

Clinical Roundup

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

FDA to remove black box warnings on hormone therapy for menopause

Trump-era “gold standard science” is not to be confused with gold standard of scientific evidence

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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

HHS announces initiative to improve breast cancer screening and early detection

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

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