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Chemotherapy-free neoadjuvant pembrolizumab combined with trastuzumab and pertuzumab in HER2-enriched early breast cancer (WSG-KEYRICHED-1): a single-arm, phase 2 trial

May 1, 2025

The WSG-KEYRICHED-1 phase II trial evaluated a chemotherapy-free neoadjuvant regimen of pembrolizumab plus trastuzumab and pertuzumab in HER2-enriched early breast cancer, achieving a pathological complete response (pCR) rate of 46.5% (95% CI 31.2–62.6%). No survival data (e.g., EFS or OS) were reported, but the regimen showed an acceptable safety profile with no new cardiac toxicity signals. The chemo-free approach suggests promising potential for de-escalation in this subtype, but we’ll need randomized trials to confirm its efficacy and safety.

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Neoadjuvant PD-1 and PD-L1 Blockade With Chemotherapy for Borderline Resectable and Unresectable Stage III Non–Small Cell Lung Cancer

May 1, 2025

The phase II trial of neoadjuvant PD-1/PD-L1 blockade plus chemotherapy in borderline resectable and unresectable stage III NSCLC showed a significant improvement in event-free survival (EFS) with the combination (24.1 vs 10.6 months) compared to chemotherapy alone, with a hazard ratio (HR) of 0.62. Major pathological response rates were higher with immunotherapy (44.7% vs 22.3%), and no new safety signals were noted. The regimen improved surgical resection rates (68% vs 52%) without increasing perioperative complications. This validates chemoIO in the neoadjuvant setting particularly in whom we wish to pursue resection or avoid chemoradiation. It would be great to see this compared to chemoradiation followed by immunotherapy rather than chemotherapy alone.

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Randomized Phase III Trial of Ramucirumab Beyond Progression Plus Irinotecan in Patients With Ramucirumab-Refractory Advanced Gastric Cancer: RINDBeRG Trial

May 1, 2025

The RINDBeRG phase III trial investigated Ram + IRI versus IRI alone in Ram-refractory advanced gastric cancer, showing a significant improvement in progression-free survival (PFS) (3.8 vs 2.8 months) but no significant difference in overall survival (OS) (9.4 vs 8.5 months). The combination therapy achieved a higher overall response rate (ORR) (22.1% vs 15.0%) and disease control rate (DCR) (64.4% vs 52.1%), indicating likely modest antitumor activity. This combo offers a slight edge in delaying progression, but the lack of overall survival (OS) benefit means we’ll need to carefully consider its role in practice.

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Acalabrutinib Plus Bendamustine-Rituximab in Untreated Mantle Cell Lymphoma

May 1, 2025

The ECHO phase III trial evaluated acalabrutinib + bendamustine-rituximab (BR) vs placebo plus BR in untreated mantle cell lymphoma (MCL) patients ineligible for transplant, showing a significant improvement in progression-free survival (PFS) (66.4 vs 49.6 months) with a hazard ratio (HR) of 0.73. The combination achieved a higher overall response rate (ORR) (91.0% vs 88.0%) and complete response (CR) rate (66.6% vs 53.5%), supporting its efficacy in this older population. Of note, side effects like pneumonia, atrial fibrillation, and infections were more frequent with acalabrutinib, with serious adverse effects in 69% versus 62% for placebo. This triplet regimen could redefine first-line treatment for our MCL patients, but we’ll need to stay vigilant about managing toxicities, especially in older patients.

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Phase II (Alliance A091802) Randomized Trial of Avelumab Plus Cetuximab Versus Avelumab Alone in Advanced Cutaneous Squamous Cell Carcinoma

May 1, 2025

The Alliance A091802 phase II trial evaluated avelumab + cetuximab vs avelumab alone in advanced-cSCC, demonstrating an improvement in progression-free survival (PFS) (11.1 vs 3.0 months) with a hazard ratio (HR) of 0.48. The combo achieved a modestly higher overall response rate (ORR) (27.6% vs 21.4%), suggesting synergy of the dual blockade. This non-chemotherapy combo shows real promise for our patients with advanced cSCC, but we’ll need to keep an eye on the toxicity profile (more rash and allergic reactions) as we consider it for broader use.

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Daratumumab or Active Monitoring for High-Risk Smoldering Multiple Myeloma

May 1, 2025

The AQUILA trial compared daratumumab to active monitoring in high-risk smoldering multiple myeloma, demonstrating a significant improvement in progression-free survival (PFS) (84% vs 54% at 48 months) and a trend toward better overall survival (OS) (94% vs 86% at 48 months). Dara also achieved a higher rate of deep responses, with 60% of patients reaching minimal residual disease (MRD) negativity compared to none in the monitoring arm. This looks like a game-changer to delay progression, but we’ll need to weigh the toxicity profile carefully in practice and wait for survival data.

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Overall Survival with Inavolisib in PIK3CA-Mutated Advanced Breast Cancer

May 1, 2025

The INAVO120 trial assessed inavolisib + palbociclib–fulvestrant vs placebo plus palbociclib–fulvestrant in PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer, showing significant improvements in progression-free survival (PFS) (15.0 vs 7.3 months) and overall survival (OS) (34.0 vs 27.0 months). The triplet regimen achieved a higher overall response rate (ORR) (62.7% vs 28.0%), establishing it as a potential new standard for this endocrine-resistant population. Notably, side effects like hyperglycemia, stomatitis, diarrhea, and ocular effects were more frequent with inavolisib.

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Adjuvant Cemiplimab or Placebo in High-Risk Cutaneous Squamous-Cell Carcinoma

May 1, 2025

The C-POST trial investigated adjuvant cemiplimab vs placebo in high-risk cutaneous squamous cell carcinoma (CSCC) post-surgery and radiation, demonstrating significant improvement in disease-free survival (DFS) (24-month 87% vs 64%) with a 68% reduction in recurrence or death risk (HR 0.32). There were also reduced locoregional and distant recurrence rates. If approved, this would be the first drug in this indication, so keep an eye out for the FDA review.

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Trastuzumab Deruxtecan or Ramucirumab plus Paclitaxel in Gastric Cancer

May 1, 2025

The DESTINY-Gastric04 trial compared trastuzumab deruxtecan (T-DXd) vs ramucirumab + paclitaxel as second-line therapy for HER2+ advanced gastric or gastroesophageal junction (GEJ) cancer, showing significant improvements in progression-free survival (PFS) (7.1 vs 5.7 months) and overall survival (OS) (13.6 vs 10.2 months). The antibody-drug conjugate (ADC) also achieved a higher objective response rate (43.6% vs 28.4%). This is no surprise as this T-DXd seems to be a game changer in many diseases. Toxicities were as expected.

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Encorafenib, Cetuximab, and mFOLFOX6 in BRAF-Mutated Colorectal Cancer

May 1, 2025

The BREAKWATER trial evaluated encorafenib, cetuximab, and mFOLFOX6 as a first-line therapy for BRAF V600E–mutated metastatic colorectal cancer, showing very significant improvements in progression-free survival (PFS) (12.8 vs 7.1mos) and overall survival (OS) (30.3 vs 15.1mos). The combo also achieved a higher overall response rate (ORR). (60 vs 40%), positioning it as a new standard for this challenging patient population. Of note, side effects like nausea, diarrhea, and neuropathy, which were more frequent with this regimen. I would use this in the appropriate patient.

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FCS Hematology Oncology Review creates a platform for our physician network to observe the most recent articles and studies available in the oncology and hematology world. By sharing these articles we are building our wealth of knowledge of new observations and treatments as they come available.

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