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Celcuity's Gedatolisib Beats Novartis's Alpelisib in Phase 3 VIKTORIA-1 PIK3CA-Mutant Breast Cancer Trial
Celcuity announced on May 1, 2026, that the Phase 3 VIKTORIA-1 trial met its primary PFS endpoint, with the gedatolisib triplet (gedatolisib + fulvestrant + palbociclib) demonstrating a statistically significant and clinically meaningful improvement in progression-free survival versus alpelisib (Piqray) + fulvestrant in patients with HR+/HER2-/PIK3CA-mutant advanced breast cancer after CDK4/6 inhibitor + AI progression, according to Fierce Biotech. The secondary endpoint comparing the gedatolisib doublet (gedatolisib + fulvestrant) versus alpelisib + fulvestrant also showed significant PFS improvement. Gedatolisib is a pan-PI3K/mTOR dual inhibitor. Detailed results will be presented as a late-breaking abstract at ASCO (May 29–June 2, 2026). Celcuity already has an NDA under Priority Review for gedatolisib in PIK3CA wild-type breast cancer (PDUFA July 17, 2026) and plans an sNDA for the PIK3CA-mutant indication. Piqray generated $382 million in 2025 revenue (down 15%), facing pressure from Roche's inavolisib (Itovebi). Celcuity secures potential best-in-class positioning across PIK3CA subtypes Novartis's Piqray franchise faces direct competitive displacement
Nuvalent forges Guardant Health alliance for precision oncology diagnostics expansion
Nuvalent announced on April 30, 2026, a multi-year companion diagnostics collaboration with Guardant Health, leveraging Guardant's Infinity™ liquid biopsy platform across Nuvalent's targeted oncology pipeline, including zidesamtinib (ROS1-selective) and NVL-655 (ALK-selective) for non-small cell lung cancer (Fierce Biotech). The alliance positions Nuvalent to develop blood-based companion diagnostics alongside its clinical programs in ROS1-positive, ALK-positive, and HER2-altered NSCLC, rather than building internal diagnostic capabilities. Guardant's established liquid biopsy technology provides a validated platform for identifying patients most likely to benefit from Nuvalent's precision therapies. Nuvalent secures diagnostic expertise without internal investment Guardant expands companion diagnostic footprint in targeted therapy The collaboration reflects the evolving model where targeted therapy success increasingly depends on diagnostic-therapeutic integration from early development stages.
FDA Accepts Protocol Amendment to Nanobiotix/J&J Phase 3 NANORAY-312 Trial of NBTXR3 in HNSCC
Nanobiotix and Johnson & Johnson announced FDA acceptance of a protocol amendment to the Phase 3 NANORAY-312 trial evaluating NBTXR3 (JNJ-1900), a hafnium oxide radioenhancer activated by radiotherapy, in locally advanced head and neck squamous cell carcinoma (CancerNetwork). The amendment eliminates the planned interim analysis, which Nanobiotix stated could accelerate topline results to H1 2027. NANORAY-312 is a 1:1 randomized trial comparing NBTXR3 + radiotherapy ± cetuximab versus placebo + radiotherapy ± cetuximab in patients aged 60+ who are cisplatin-ineligible, with PFS as the primary endpoint. J&J holds global commercialization rights to NBTXR3 under a 2022 licensing agreement. Nanobiotix/J&J accelerate potential first-in-class radioenhancer toward registration The trial addresses a significant unmet need in elderly, cisplatin-ineligible HNSCC patients with limited treatment options.
Pipeline Watch
MimiVax partnered with Roswell Park to initiate Phase 2 evaluation of SurVaxM vaccine targeting survivin in metastatic neuroendocrine tumors (PharmaTimes). The survivin-targeting approach expands beyond brain cancer applications, potentially addressing a significant unmet need in neuroendocrine malignancies where treatment options remain limited.
Merck initiated the Phase 3 MK-6482-033 study combining belzutifan (Welireg) with Exelixis's zanzalintinib versus cabozantinib monotherapy in patients with recurrent renal cell carcinoma following adjuvant therapy (ClinicalTrials.gov). Belzutifan is an HIF-2α inhibitor co-developed with Exelixis for certain RCC combinations. The trial explores extending belzutifan's utility beyond VHL-associated applications into broader post-adjuvant kidney cancer treatment.
Genmab and AbbVie initiated a China-specific Phase 3 sub-study comparing epcoritamab (Epkinly), a CD3×CD20 bispecific antibody, against investigator's choice chemotherapy in relapsed/refractory DLBCL patients, with overall survival as the primary endpoint (ClinicalTrials.gov). The regional trial design reflects the increasing importance of China-specific data for global bispecific antibody approvals and market access strategies.
The SWOG S1826 trial (NCT03907488) comparing nivolumab-AVD (N-AVD) versus brentuximab vedotin-AVD (BV-AVD) in newly diagnosed Stage III-IV classic Hodgkin lymphoma has published practice-changing results in the New England Journal of Medicine, demonstrating 92% two-year PFS with N-AVD versus 83% with BV-AVD (ClinicalTrials.gov; NEJM). The trial has completed enrollment and is in follow-up for long-term overall survival data.
Competitive Landscape
Celcuity's Phase 3 VIKTORIA-1 victory over Piqray reshapes PIK3CA-mutated breast cancer competitive dynamics (Fierce Biotech). Celcuity gains potential best-in-class positioning across PIK3CA subtypes Novartis's Piqray franchise ($382M, 2025) faces direct competitive displacement Gedatolisib's dual PI3K/mTOR mechanism may provide superior efficacy compared to PI3Kα-selective approaches.
| Company | Drug | Mechanism | Status |
|---|---|---|---|
| Celcuity | Gedatolisib | Pan-PI3K/mTOR | Phase 3 Win (VIKTORIA-1) |
| Novartis | Alpelisib (Piqray) | PI3Kα-selective | Marketed ($382M) |
| Roche | Inavolisib (Itovebi) | PI3Kα-selective | Marketed (2024) |
Nuvalent's Guardant alliance demonstrates essential integration between targeted therapies and diagnostic platforms for ROS1/ALK/HER2-altered NSCLC (Fierce Biotech). Biotech companies increasingly recognize that successful precision medicine requires diagnostic partnerships rather than internal development, shifting competitive advantages toward platform integration capabilities.
Nanobiotix/J&J's NANORAY-312 protocol amendment acceptance, eliminating the interim analysis and potentially accelerating results to H1 2027, signals growing FDA confidence in the NBTXR3 radioenhancer platform for cisplatin-ineligible HNSCC patients (CancerNetwork). A positive readout could establish a new treatment paradigm for elderly head and neck cancer patients with limited options.
Forward Looking
- Celcuity's ASCO late-breaking abstract (May 29–June 2, 2026) will reveal detailed VIKTORIA-1 data for gedatolisib versus Novartis's Piqray in PIK3CA-mutated breast cancer; the gedatolisib NDA for PIK3CA wild-type has a PDUFA date of July 17, 2026.
- Nanobiotix/J&J's NANORAY-312 trial of radioenhancer NBTXR3 in cisplatin-ineligible HNSCC targets topline results in H1 2027, following elimination of the planned interim analysis.
- Companion diagnostics partnerships like Nuvalent's Guardant collaboration may become essential for precision oncology success as regulatory requirements increasingly demand integrated diagnostic strategies from early development.
- MimiVax's survivin vaccine (SurVaxM) expansion into neuroendocrine tumors at Roswell Park tests whether cancer vaccine approaches can address multiple solid tumor types beyond initial glioblastoma applications.