From the Watchtower · Page 2
Oncology intelligence, in the open.
Briefings 25–48 of 65, newest first.
Per Endpoints, Merck's Welireg-Lenvima wins FDA approval in advanced ccRCC
The FDA approved belzutifan plus Eisai's lenvatinib on 24 September 2026 for adults with advanced renal cell carcinoma with a clear-cell component after a PD-1 or PD-L1 inhibitor, pushing the HIF-2α inhibitor past its VHL-disease niche.
Per Endpoints, Elevar's Lyrfigtu wins first FDA nod in FGFR2 bile duct cancer
Endpoints News reports the FDA cleared lirafugratinib for FGFR2 fusion or rearrangement cholangiocarcinoma second-line, Elevar's first approval, in a cancer diagnosed in about 8,000 Americans a year.
SOTIO's SOT106 ADC lands FDA Orphan Drug and osteosarcoma Fast Track
The LRRC15-targeting antibody-drug conjugate now holds Orphan Drug status in soft tissue sarcoma and Fast Track in osteosarcoma, per SOTIO, but it has yet to dose a patient.
MAIA reports Phase 3 THIO enrolling on pace in 3rd-line NSCLC
MAIA's 22 September release cites enrollment momentum, not data, for the 300-patient THIO-104 trial of its telomere-targeting agent sequenced ahead of cemiplimab after checkpoint-inhibitor failure.
CHMP backs J&J's teclistamab for earlier-line relapsed/refractory myeloma
The EMA's committee adopted a positive opinion on 17 September 2026 recommending TECVAYLI after just one prior therapy, per the EMA, J&J's release and OncLive, pushing the BCMA bispecific fight closer to second line.
CancerNetwork: CHMP backed Lifyorli combo for platinum-resistant ovarian cancer
CancerNetwork and Corcept's wire release via STT Info report the glucocorticoid-receptor antagonist combo cleared the EMA's CHMP on 18 September 2026; the binding European Commission decision follows, which the company expects in the fourth quarter of 2026.
Roche says Lunsumio combo hits PFS goal in Phase 3 CELESTIMO trial
Roche reports its Phase III CELESTIMO trial of mosunetuzumab plus lenalidomide beat rituximab plus lenalidomide on progression-free survival in relapsed/refractory follicular lymphoma, the confirmatory study for the bispecific's US accelerated approval.
Pfizer withdraws EU bladder cancer filing for Zumrad after CHMP concerns, per AllSci
Trade press reports the CHMP-triggered retreat ended Zumrad's EU Joint Clinical Assessment; a later report frames it as Pfizer following AstraZeneca, a link Prognyx could not confirm in primary records.
Enhertu posts 14.3-month first-line PFS in HER2-mutant NSCLC (DESTINY-Lung04)
AstraZeneca reports a Phase III first-line PFS win over the immunotherapy-chemo standard; the hazard ratio and overall survival are not yet disclosed.
Gotistobart lifts median OS in PRESERVE-003 stage 1 squamous NSCLC
BioNTech and OncoC4 reported 18.5-month median OS versus 10.0 months for docetaxel in non-pivotal stage 1 of PRESERVE-003; the pivotal stage 2 test is still the decision point. [1]
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.
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.