Memorial Sloan Kettering Cancer Center

KEYNOTE-564 trial (NCT03142334) in clear cell renal cell carcinoma (ccRCC) patients demonstrated a significant OS benefit with pembrolizumab vs placebo, marking a paradigm shift in adjuvant immunotherapy for kidney cancer.

FDA approval of lutetium-177 (177Lu) vipivotide tetraxetan (177Lu PSMA-617; Pluvicto) for metastatic castration-resistant prostate cancer (mCRPC) has led to its widespread use, with ongoing research exploring its potential in earlier disease stages. Oncologists are adapting to its regular use, focusing on patient selection via PSMA-PET scans. Early therapy with 177Lu-PSMA-617 has shown benefits in radiographical progression-free survival (rPFS) and quality of life (QOL), with ongoing trials aiming to expand its indications and improve patient outcomes.

FDA approves Itovebi, a new breast cancer drug for hormone-sensitive, HER2-negative, PIK3CA-mutated cases, doubling progression-free survival to 15 months. Itovebi, inavolisib, is taken with palbociclib and fulvestrant. Common side effects include lab abnormalities, mouth inflammation, diarrhea, fatigue, nausea, rash, decreased appetite, COVID-19 infection, and headache, with a hyperglycemia risk.

Durvalumab (Imfinzi) and pembrolizumab (Keytruda) combinations are now standard in perioperative treatment for resectable NSCLC. These neoadjuvant ICIs plus chemotherapy followed by adjuvant ICI regimens significantly improve event-free survival and pathologic complete response rates. The approach is well-tolerated and often yields complete eradication of cancer, challenging traditional progression management strategies. Upcoming conferences will further explore these advancements and their implications for patient care.

The nanomedicine market was valued at USD 223.6 billion in 2023 and is projected to reach USD 634.2 billion by 2032, with a CAGR of 12.2%. This growth is driven by increased demand for advanced drug delivery systems and rising chronic disease incidence. North America leads the market, while Asia-Pacific is expected to grow the fastest.

The nanomedicine market, valued at USD 223.6 billion in 2023, is projected to reach USD 634.2 billion by 2032, driven by advanced drug delivery systems and rising chronic diseases. Key players include Johnson & Johnson, Mallinckrodt Pharmaceuticals, and Teva Pharmaceutical Industries. Recent developments include Novartis's nanoparticle-based ovarian cancer treatment and Merck's partnership with Stanford for immunotherapy research.

FDA approves Itovebi (inavolisib) in combo with palbociclib and fulvestrant for HR-positive, HER2-negative, PIK3CA-mutated breast cancer, based on INAVO120 study showing 57% reduction in disease worsening risk. Itovebi-based regimen more than doubled progression-free survival, maintaining manageable safety and tolerability.

Dr. Steven-Huy Han prescribes Ocaliva for primary biliary cholangitis, unsure of its long-term benefits. The FDA's accelerated approval process, often based on surrogate markers, has led to debate over drug effectiveness. Ocaliva's approval was supported by patient testimony, despite limited long-term data. The FDA requires additional trials post-approval, but some companies struggle to meet these requirements. The accelerated approval process, driven by impatience for new treatments, has led to the approval of drugs with uncertain long-term benefits.

Martin H. Voss discusses the CheckMate 214 trial evaluating nivolumab plus ipilimumab in intermediate/poor-risk RCC, showing benefits in ORR and PFS. NCCN and FDA endorse this combination for these patients, though favorable-risk patients had better short-term outcomes with sunitinib. Recent 8-year follow-up data highlights long-term benefits and treatment-free survival as a new end point.

The FDA approved Roche’s Itovebi (inavolisib) combined with Ibrance and Faslodex for HR-positive, HER2-negative, PIK3CA-mutated breast cancer, based on the Phase III INAVO120 trial showing significant PFS improvement. The regimen more than doubled PFS and maintained a manageable safety profile, offering a new treatment standard for PIK3CA-mutated breast cancers.