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Oncology competitive-intelligence briefings: trials, readouts, FDA moves and deals, traced to the primary record and published as the field moves.
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Merck's pembrolizumab cuts progression risk 43% in dMMR endometrial cancer
FDA approves Pfizer's talazoparib-enzalutamide for HRR-mutant prostate cancer
The 26 October approval covers androgen pathway modulation-naive or -sensitive disease across 12 HRR genes, wider than AKEEGA's BRCA2-restricted combination label.
Amgen's Imdelltra plus Imfinzi cuts death risk 58% in first-line ES-SCLC
Phase III DeLLphi-305 data, presented at ESMO and published in NEJM, cut the risk of death by 58% for the tarlatamab plus durvalumab first-line maintenance combination versus durvalumab alone in extensive-stage small cell lung cancer.
Innovent's arcotatug tavatecan clears OS and PFS in Phase 3 gastric cancer at ESMO
Keytruda-Padcev wins EU approval for resectable bladder cancer, any cisplatin status
The European Commission's 21 October clearance makes pembrolizumab plus enfortumab vedotin, per Merck, the EU's first PD-1-inhibitor-plus-ADC perioperative regimen for muscle-invasive bladder cancer without a cisplatin-eligibility restriction.
FDA accelerated approval: GSK's Jemperli, first immunotherapy for dMMR rectal cancer
Accelerated approval rests on the single-arm AZUR-1 trial, where 68% of evaluable patients reached a clinical complete response at 12 months by investigator read while the blinded primary endpoint sits at 47% and is still maturing [1][2].
Riboscience to present RBS2418's first overall-survival data at ESMO 2026
Riboscience says its ESMO 2026 poster will carry first Phase 1b overall-survival and immune-activation data for its lead oral ENPP1 inhibitor RBS2418, as monotherapy and in combination in advanced metastatic cancers including MSS colorectal cancer; the figures themselves are not yet public.
CHMP backs a label change for Janssen's myeloma bispecific Talvey
On 15 October 2026 the CHMP recommended a change to Talvey's EU marketing authorisation; the EMA record does not state what the change covers.
Verastem's VS-7375 hits 50% response in second-line pancreatic cancer, Phase 3 next
FDA expands ImmunityBio's Anktiva label to papillary-only NMIBC
The 14 October approval adds high-grade papillary-only tumors to the Anktiva plus BCG label, a group ImmunityBio puts at roughly 85% of non-muscle invasive bladder cancer.
Gilead pays Vir $90M upfront for three masked T-cell engagers in solid tumors
Gilead takes an exclusive license to three preclinical PRO-XTEN dual-masked T-cell engagers; Vir keeps discovery and is eligible for up to $135M upfront and near-term, plus up to $1.74B in later milestones.
Intismeran autogene improves RFS and DMFS in resected melanoma, Merck says
Merck and Moderna will present the first Phase 3 data for their personalized mRNA vaccine plus Keytruda at the ESMO 2026 Presidential Symposium, with Moderna already preparing for a potential launch.
T-MAXIMUM wins FDA clearance for a Phase 2 CAR-T trial in brain metastases
T-MAXIMUM's B7-H3 allogeneic CAR-T MT027 moves into lung and breast brain metastases; the clearance rests on the company's own release, with no trial registration yet.
FDA approves atezolizumab plus chemo for adjuvant Stage III dMMR colon cancer
Genentech's atezolizumab moves from unresectable, metastatic dMMR tumors into curative-intent adjuvant therapy for resected Stage III colon cancer, cleared on the ATOMIC trial's disease-free survival outcome.
FDA approves Pfizer's tucatinib triplet for HER2-positive breast cancer maintenance
The 7 October approval adds oral tucatinib to a trastuzumab and pertuzumab maintenance backbone after induction, on the strength of the 654-patient HER2CLIMB-05 trial; Prognyx could not confirm the size of the benefit from public sources in this briefing.
AbbVie's c-Met ADC wins dual FDA Breakthrough Therapy tags in CRC and lung cancer
The c-Met antibody-drug conjugate ABBV-400, carrying a topoisomerase 1 inhibitor payload, gains US Breakthrough Therapy Designation in colorectal and non-small cell lung cancer.
Epcoritamab plus R-CHOP cuts first-line DLBCL progression risk 51% in Phase 3
Genmab and AbbVie's CD3xCD20 bispecific added to R-CHOP met the Phase 3 trial's primary endpoint in newly diagnosed DLBCL; in all enrolled patients (IPI 2-5, a key secondary endpoint) the risk of progression or death was cut 51% (HR 0.49, 95% CI 0.36-0.67, p<0.0001) versus R-CHOP alone, on a topline readout.
Revolution Medicines begins dosing its RAS(ON) doublet in G12D pancreatic cancer
Revolution Medicines has begun treating patients in RASolute 309 (NCT07805954), a global Phase 3 study pitting its RAS(ON) doublet against gemcitabine and nab-paclitaxel in first-line metastatic RAS G12D pancreatic cancer, with primary completion targeted for March 2029.
FDA clears Lilly's pirtobrutinib for untreated CLL without 17p deletion
The 2 October approval, based on BRUIN CLL-313 versus bendamustine plus rituximab, moves Lilly's reversible BTK inhibitor from relapsed mantle cell lymphoma into untreated CLL/SLL.
AstraZeneca and Daiichi Sankyo to evaluate Datroway with Summit's ivonescimab
AstraZeneca and Daiichi Sankyo will evaluate their Trop-2 ADC Datroway in combination with Summit Therapeutics' ivonescimab across multiple tumour types.
Roche's giredestrant combo improves PFS in post-CDK4/6i ER+ breast cancer
Roche's investigational oral SERD plus everolimus beat standard endocrine therapy plus everolimus on progression-free survival in the post-CDK4/6i setting; the hazard ratio and median PFS are not yet public.
Merck licenses preclinical KRAS G12D(ON) inhibitor SPR2015 from SciBrunch
An exclusive global license announced 28 September 2026 brings Merck a preclinical oral KRAS G12D(ON) inhibitor.
AstraZeneca takes $2B Summit stake, pairs its Claudin 18.2 ADC with ivonescimab
AstraZeneca pairs its Claudin 18.2 ADC sonesitatug vedotin with Summit's PD-1/VEGF bispecific ivonescimab in GI cancers, buying into overall-survival wins over pembrolizumab and durvalumab.
Merck and Daiichi Sankyo withdraw I-DXd accelerated-approval BLA
The sponsors ended the US accelerated-approval filing after FDA discussions, while the randomized Phase 3 survival trial continues.[1][2]