From the Watchtower
Oncology intelligence, in the open.
Oncology competitive-intelligence briefings — trials, readouts, FDA moves and deals, traced to the primary record and published as the field moves.
Every briefing is written and audited by a named person, and every fact traces to a document you can open. See the method · Oncology competitive intelligence
The Watchtower, by email
One email per briefing, nothing else. You confirm by clicking the link we send; you leave in one click.
Double opt-in. Never sold, no open tracking. Privacy.
BeOne’s CLL Phase 3 puts sonrotoclax against venetoclax plus acalabrutinib
The recruiting 500-patient NCT07277231 trial turns BeOne’s sonrotoclax-zanubrutinib strategy from a broad CLL program into a direct fixed-duration BCL2/BTK combination contest, while public sources still show no results for the pivotal CLL studies.[1]
Zipalertinib's REZILIENT3 hits its PFS endpoint in first-line EGFR exon 20 lung cancer; full data land 13 September
Taiho and Cullinan report a Phase 3 first-line PFS win at interim; the hazard ratio and median PFS are not yet disclosed and are set for IASLC on 13 September 2026, while the only regulatory date on record — a 27 February 2027 PDUFA — governs a separate post-platinum filing.
Per Endpoints News, Bristol Myers Squibb claims Phase 2 success for a GPRC5D-directed CAR-T in multiple myeloma
Endpoints News reports the win frames a GPRC5D CAR-T as a post-relapse option for myeloma patients who progress after CAR-T therapy.
AstraZeneca reports durvalumab-tarlatamab maintenance improves survival in first-line ES-SCLC
The company's 8 September press release reports statistically significant overall and progression-free survival gains from adding tarlatamab to durvalumab first-line maintenance, after durvalumab plus platinum-etoposide induction, in NCT07005128; no hazard ratios, medians or p-values were released.
Per Endpoints News, Novartis pauses immunology and neuroscience CAR-T studies after three patient deaths
Per Endpoints News, Novartis has halted immunology and neuroscience studies of an experimental CAR-T therapy after three patient deaths.
Pfizer licenses its terminated CD228 ADC PF-08046031 to Medicus Pharma while keeping the patents and over $1B in potential milestones
Prognyx read: a large pharma divesting an ADC rather than buying one — Pfizer hands off a Seagen-derived asset it had already shelved (per Endpoints and Fierce Biotech), but structures the exit to keep patent ownership and pivotal-stage optionality.
FDA grants accelerated approval to AstraZeneca's Etcamah (camizestrant), an oral SERD, for ESR1-mutant HR+/HER2- advanced breast cancer
The FDA granted accelerated approval to Etcamah (camizestrant) for HR-positive, HER2-negative advanced breast cancer upon detection of an ESR1 mutation during aromatase-inhibitor and CDK4/6-inhibitor therapy — the SERENA-6 switch setting — months after a spring-2026 adcomm reportedly voted against the drug.
AbbVie's etentamig cuts progression-or-death risk 60% in Phase 3 CERVINO myeloma trial
AbbVie reports the BCMA×CD3 bispecific met dual primary endpoints versus standard therapies; the readout rests on trade coverage and a syndicated release, and Prognyx maps CERVINO to registered Phase 3 trial NCT06158841 on matching trial design.
Summit files HARMONi-2 OS-positive update for ivonescimab
Summit’s 3 September 2026 8-K says Akeso reported statistically significant OS improvement for ivonescimab monotherapy versus pembrolizumab monotherapy in China’s HARMONi-2 Phase III trial in PD-L1-positive advanced NSCLC. [1]
Per Endpoints, a CBER Director Overruled Reviewers to Clear Replimune's Tudriqev
Endpoints reports that Asha Das overruled CBER reviewers to grant accelerated approval to Replimune's melanoma treatment Tudriqev; Prognyx did not receive a primary FDA approval record, label or review memo in the dossier [1].
Enhertu plus pertuzumab wins EU first-line HER2-positive metastatic breast cancer approval
AstraZeneca says the European approval creates the first new first-line HER2-positive metastatic breast cancer regimen in more than a decade [1]; the supplied dossier did not include an EMA/EC label, EPAR, pivotal trial identifier, or efficacy table behind the decision.
Briefing ·PMV announces 31 August rezatapopt ovarian update for PYNNACLE
PMV announced updated interim rezatapopt ovarian data on 31 August 2026; the updated ORR, safety, cutoff date, denominator, and central-review data are not present in the supplied dossier excerpt.[1]
Ipsen closes the Kartos acquisition — and inherits one recruiting Phase 3 with a 31 December 2026 primary completion date
The MDM2 inhibitor navtemadlin arrives at Ipsen as a single live trial — 600 patients, placebo-controlled on top of ruxolitinib — while four earlier Kartos studies sit unverified on the registry with no results posted. A USD 450m price tag comes from a press headline, not from the release text Prognyx could read.
Merck and Moderna declare a Phase 3 melanoma win for intismeran autogene, per Endpoints News — Moderna's own filings had put the readout on the 2026 calendar
Endpoints News reports the personalized cancer vaccine succeeded in its first Phase 3; the endpoint detail comes from a joint release Prognyx could reach only through a news aggregator, while the primary records — a JCO five-year Phase IIb dataset and three Moderna 8-K exhibits — describe the programme around the result rather than its size.
Iberdomide (Zenbexus) wins accelerated approval in relapsed myeloma — and five sponsors already run combinations built on it
Endpoints News reported the clearance on 13 August 2026; Prognyx located no FDA label or agency record, the exact agency action date is unconfirmed, and the randomized phase 3 EXCALIBER-RRMM (NCT04975997) does not reach primary completion until 16 November 2027.
Zipalertinib plus chemo meets its PFS endpoint at interim in first-line EGFR exon 20 NSCLC
REZILIENT3, a randomised open-label Phase 3 in 285 previously untreated patients, hit its primary endpoint at a planned interim; the Independent Data Monitoring Committee recommended unblinding and the partners will seek US approval pending FDA discussions.
Endpoints reports the FDA rejected ITM's neuroendocrine-tumor radiopharmaceutical over manufacturing
Endpoints News reported on 10 August 2026 that the FDA rejected ITM Isotope Technologies Munich's radiopharmaceutical for neuroendocrine tumors, with manufacturing cited and no clinical or safety point reported in the sources reviewed.
Divesiran hits 88% versus 19% in Phase 2 polycythemia vera — Silence takes quarterly dosing into a 1H 2027 Phase 3
Topline comes from Silence's own release filed as an 8-K exhibit on 10 August 2026; Prognyx retrieved no ClinicalTrials.gov record for SANRECO, and no rusfertide primary source, so no comparison to rusfertide is drawn here.
Briefing ·Galleri's randomized endpoint came back at 1.03 — and an FDA advisory committee is reported for September
GRAIL's randomised NHS-Galleri trial read 1.03 (95% CI 0.92–1.14, p=0.6234) against its own primary endpoint, in the company's SEC-filed deck. Endpoints News reports an FDA advisory committee for September 2026; Prognyx found no FDA notice, committee name or meeting date among the primary records assembled here.
Two Phase 3s target low-intensity follicular lymphoma standards: surovatamig vs radiotherapy, mosunetuzumab vs rituximab
NCI's NCT06337318 is recruiting toward 600; ALLG's NCT07736950 is due to open 12 January 2027 with 138 planned — surovatamig's mechanism is not in the records reviewed.
Nurix enrols the first patient in a Phase 3 designed to demonstrate bexobrutideg's superiority over pirtobrutinib
Nurix says DAYBreak CLL-306 is designed to demonstrate superiority, not non-inferiority; the registry record named in the release, NCT07516093, lists 620 patients, progression-free survival by independent review committee and primary completion in October 2029.
Pluvicto approved with an ARPI in PSMA-positive mHSPC: radioligand therapy arrives in first-line metastatic prostate cancer
Novartis announced the FDA approval on 31 July 2026; the Prescribing Information Prognyx reviewed still carries only the castration-resistant indication, and no efficacy data from the registrational trial appears in the public records available.
Selinexor's TP53 wild-type bet misses: XPORT-EC-042 returns a hazard ratio of 0.76 (95% CI 0.51–1.12), double the SIENDO subgroup's 0.38
Karyopharm's confirmatory Phase 3 in TP53 wild-type endometrial cancer failed on progression-free survival — and on a cross-trial read, about four-fifths of the lost separation sits in the control arm, not the drug arm.
J&J's reported $785M upfront for Sail comes with a $2.58B option on in vivo CAR-T — and almost no clinical record to price it against
The $2.58 billion acquisition option rests on a single trade report; the nearest in vivo-adjacent myeloma Phase 1 in the records reviewed has not opened, and the sourced ex vivo contrast case still gives chemotherapy conditioning before infusion.