Your go-to digest for the latest breakthroughs in cancer care.

From a landmark EU approval of perioperative immunotherapy in bladder cancer to strong CAR‑T durability and promising oral regimens in haematological malignancies, this week’s oncology updates show how targeted drugs and regulatory advances are driving better survival and improves patient outcomes.

Leading voices. Big insights. Scroll down to watch now Dr. Grant Jirka’s Oncology Spotlight!

Imfinzi (Durvalumab) Gains EU Approval in Muscle-Invasive Bladder Cancer Based on NIAGARA Trial Results

The European Commission has approved AstraZeneca’s Imfinzi (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy, for adult patients with resectable muscle-invasive bladder cancer (MIBC).

This regulatory nod follows results from the Phase III NIAGARA trial, which demonstrated a 32% reduction in risk of disease progression, recurrence, or death (HR 0.68; 95% CI, 0.56–0.82; p<0.0001) and a 25% reduction in risk of death (HR 0.75; 95% CI, 0.59–0.93; p=0.0106) compared to neoadjuvant chemotherapy alone. At two years, 82.2% of patients treated with the Imfinzi regimen were alive, and 67.8% were event-free.

Imfinzi was well tolerated, with no new safety signals, and was consistent with known profiles in neoadjuvant and adjuvant settings. The ESMO Magnitude of Clinical Benefit Scale (MCBS) awarded this regimen the highest grade of “A” in the curative setting. Regulatory submissions are ongoing in Japan and other countries. (Reference: AstraZeneca. “Imfinzi Approved in the EU Based on NIAGARA Phase III Results.” July 2025)

STAMPEDE Trial: Metformin Shows No Significant Survival Benefit in mHSPC, But Reduces ADT-Related Metabolic Effects

In the latest arm of the STAMPEDE platform Phase III trial, the addition of metformin (850 mg BID) to standard of care (SOC) in non-diabetic patients with metastatic hormone-sensitive prostate cancer (mHSPC) did not significantly improve overall survival (HR 0.91; 95% CI, 0.80–1.03; p=0.15), although median survival was numerically longer: 67.4 months vs. 61.8 months in the SOC group.

However, metformin significantly reduced adverse metabolic effects commonly seen with androgen deprivation therapy (ADT), such as weight gain and metabolic derangements. Grade 3 or worse gastrointestinal side effects were higher in the metformin group (9% vs. 7%).

While not practice-changing, the findings underscore metformin’s metabolic safety benefits and its potential utility in settings where ARPI access is limited due to cost or comorbidities. (Reference: Gillessen S. et al. “STAMPEDE Trial: Metformin in Metastatic Prostate Cancer.” The Lancet Oncology, July 2025)

Taiho’s INQOVI (decitabine and cedazuridine) + Venetoclax Accepted by FDA for AML Review

The U.S. FDA has accepted Taiho Oncology’s supplemental new drug application (sNDA) for INQOVI (decitabine and cedazuridine) in combination with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults ineligible for intensive induction chemotherapy. A standard review has been assigned with a PDUFA action date of February 25, 2026.

The submission is supported by ASCERTAIN-V (AStx727-07), a Phase 2b trial involving 101 patients, where INQOVI was administered on days 1–5 of a 28-day cycle and venetoclax daily. The trial met its primary endpoint with a complete response (CR) rate of 46.5%, while CR + CRi was 63.4%. Median overall survival was 15.5 months; at 12 months, over 75% of patients who achieved CR remained in CR.

Safety was consistent with known profiles of both agents, with no new safety signals or drug-drug interactions reported. Grade ≥3 adverse events occurred in 98% of patients, with febrile neutropenia (49.5%), anemia (38.6%), and neutropenia (35.6%) being most common.

If approved, this would be the first all-oral regimen for patients with AML who are not eligible for standard induction therapy. (Reference: Taiho Oncology Press Release, July 9, 2025; data presented at ASCO & EHA 2025)

TRANSFORM 3-Year Update Confirms Durable Benefit of Lisocabtagene Maraleucel in Second-Line LBCL

The Phase III TRANSFORM trial (NCT03575351) evaluating lisocabtagene maraleucel (liso-cel) versus standard of care (SOC) in second-line relapsed/refractory large B-cell lymphoma (LBCL) with ≤12 months of relapse post first-line therapy has reported 3-year follow-up data.

Median event-free survival (EFS) was 29.5 months with liso-cel vs. 2.4 months with SOC (HR 0.375; 95% CI, 0.259–0.542). The 3-year progression-free survival (PFS) rates were 51% vs. 26.5%, respectively. While overall survival (OS) was not reached in either arm, a crossover-adjusted OS HR of 0.566 (95% CI, 0.359–0.895) favored liso-cel.

Safety remained consistent with earlier reports, with no new safety signals. These findings reinforce liso-cel’s curative potential as a second-line therapy in LBCL. (Reference: Kamdar M. et al. “Three-Year Results from the TRANSFORM Trial.” Journal of Clinical Oncology, July 2025)

Divarasib Shows Durable Activity in KRAS G12C+ NSCLC With Favourable Long-Term Safety

Updated data from a Phase I study (NCT04449874) of divarasib (GDC-6036) in KRAS G12C–mutated non-small cell lung cancer (NSCLC) showed long-term antitumor activity and sustained safety beyond 1 year.

Among 65 patients, the objective response rate (ORR) was 55.6%, and median duration of response (DoR) reached 18.0 months. The median progression-free survival (PFS) was 13.8 months overall, and 15.3 months at the 400 mg dose level.

Divarasib, a next-generation KRAS G12C inhibitor, exhibited a favorable safety profile and high selectivity. Its extended activity profile supports its promise as a potentially superior alternative to current KRAS G12C inhibitors. (Reference: Sacher A. et al. “Divarasib in KRAS G12C–Positive NSCLC: Long-Term Results.” Journal of Clinical Oncology, July 2025)

This week’s Oncology Spotlight: Dr.Grant Jirka shares his insights on ONCOassist’s Advanced Myelofibrosis Scoring Tool

In a recent video feature, Dr. Grant Jirka, Hematology/Oncology Fellow in Los Angeles, demonstrates how the ONCOassist Advanced Myelofibrosis Scoring Tool is streamlining clinical decision-making in one of hematology’s most challenging diseases. By integrating five major prognostic models IPSS, DIPSS, DIPSS-Plus, MIPSS70, and MIPSS70-Plus, into a single, intuitive interface, the tool allows oncologists to input 12 variables and receive comprehensive risk stratification in under 90 seconds. From simplifying transplant discussions to supporting more confident, informed treatment planning, this tool is a game-changer in managing myelofibrosis.

Explore more stories & insights on ONCOassist. Your clinical edge, just a tap away.

Join the ONCOassist oncology community, the go-to CE‑approved app for oncology professionals worldwide !

Access essential tools like staging systems, toxicity scoring, drug calculators, prognostic scores and NCCN regimens,all in one place .
Stay informed with ONCOnews & ONCOvideos featuring expert insights, conference coverage and peer-tested protocols

Download the app here:

📱IOS 📱Android 💻 Webapp

Weekly Oncology Highlights – Powered by ONCOassist