This week’s Oncology update highlights regulatory progress, biomarker-driven clinical advances, ADC momentum, and expanding treatment options across solid tumours.
In Today’s Newsletter
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🧬 LP-300 HARMONIC protocol shift [1] [US • 19 May 2026]
https://ir.lanternpharma.com/news-1/news/news-details/2026/Lantern-Pharma-Announces-Successful-Outcome-of-FDA-Type-C-Meeting-Request-for-HARMONIC-Phase-2-Trial-of-LP-300-in-Never-Smokers-with-NSCLC/default.aspx
Context: Lantern Pharma is studying LP-300 plus carboplatin and pemetrexed in the Phase 2 HARMONIC trial for never-smokers with advanced NSCLC after kinase inhibitor progression.
Key point: FDA raised no objections to protocol amendments enriching for EGFR exon 21 L858R, extending LP-300 dosing to eight cycles, and moving to a single-arm design.
Implication: May influence prescriber choice and payer reviews pending full data.
🫁 HYRNUO Priority Review in 1L HER2-mutated NSCLC [2] [US • 18 May 2026]
https://www.bayer.com/en/us/news-stories/new-drug-application-for-hyrnuo
Context: Bayer’s HYRNUO (sevabertinib) is an oral HER2/EGFR TKI already accelerated-approved in previously treated HER2 TKD-mutated NSCLC.
Key point: FDA granted Priority Review for first-line use in adults with locally advanced or metastatic HER2-mutated NSCLC, based on SOHO-01 Cohort F.
Implication: May influence prescriber choice and payer reviews pending full data.
🫁 Serplulimab CHMP opinion in sqNSCLC [3] [EU • 23 May 2026]
https://www.henlius.com/en/NewsDetails-5939-26.html
Context: Henlius’ serplulimab (Hetronifly in Europe) is an anti-PD-1 mAb already approved in Europe for ES-SCLC, nsqNSCLC, and ESCC.
Key point: CHMP recommended serplulimab plus chemotherapy for 1L unresectable locally advanced or metastatic squamous NSCLC.
Implication: May influence prescriber choice and payer reviews pending full data.
🎯 Trodelvy CHMP opinion in 1L metastatic TNBC [4] [EU • 22 May 2026]
https://www.gilead.com/news/news-details/2026/gilead-receives-chmp-positive-opinion-for-trodelvy-in-first-line-metastatic-triple-negative-breast-cancer-for-patients-not-candidates-for-pd-l1-inhibitors
Context: Gilead’s Trodelvy (sacituzumab govitecan) is a Trop-2-directed ADC, with ASCENT-03 testing monotherapy in 1L metastatic TNBC not eligible for PD-1/PD-L1 inhibitors.
Key point: CHMP recommended Trodelvy monotherapy after ASCENT-03 showed a statistically significant PFS benefit versus chemotherapy.
Implication: May influence prescriber choice and payer reviews pending full data.
🎯 Datroway FDA approval in 1L metastatic TNBC [5] [US • 22 May 2026]
https://www.astrazeneca.com/media-centre/press-releases/2026/datroway-approved-in-us-for-1l-triple-negative-bc.html
Context: AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan) is a TROP2-directed DXd ADC studied in TROPION-Breast02.
Key point: FDA approved Datroway for adults with unresectable or metastatic TNBC who are not PD-1/PD-L1 inhibitor candidates.
Implication: May influence prescriber choice and payer reviews pending full data.
🧪 Camizestrant CHMP opinion in ESR1-mutated breast cancer [6] [EU • 22 May 2026]
https://www.astrazeneca.com/media-centre/press-releases/2026/camizestrant-recommended-for-breast-cancer-in-eu.html
Context: AstraZeneca’s camizestrant is an oral SERD evaluated in SERENA-6 with a CDK4/6 inhibitor for ER-positive, HER2-negative advanced breast cancer with emergent ESR1 mutation.
Key point: CHMP recommended camizestrant plus a CDK4/6 inhibitor after SERENA-6 showed reduced risk of progression or death versus aromatase inhibitor plus CDK4/6 inhibitor.
Implication: May influence prescriber choice and payer reviews pending full data.
🚻 KEYTRUDA plus Padcev CHMP opinion in MIBC [7] [EU • 22 May 2026]
https://www.merck.com/news/merck-receives-positive-eu-chmp-opinion-for-keytruda-pembrolizumab-plus-padcev-enfortumab-vedotin-ejfv-as-perioperative-treatment-for-adults-with-cisplatin-ineligible-resectable-muscle/
Context: Merck’s KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin) was studied in KEYNOTE-905/EV-303 for cisplatin-ineligible resectable muscle-invasive bladder cancer.
Key point: CHMP recommended perioperative KEYTRUDA plus Padcev, based on EFS, OS, and pCR improvements versus surgery alone.
Implication: May influence prescriber choice and payer reviews pending full data.
🚻 ANKTIVA sBLA accepted in papillary NMIBC [8] [US • 19 May 2026]
https://immunitybio.com/immunitybio-announces-fda-acceptance-of-supplemental-bla-for-anktiva-plus-bcg-in-bcg-unresponsive-non-muscle-invasive-bladder-cancer-with-papillary-disease-pdufa-date-set-for-january-6-2027/
Context: ImmunityBio’s ANKTIVA (nogapendekin alfa inbakicept) plus BCG is already FDA-approved for BCG-unresponsive NMIBC with CIS, with or without papillary tumours.
Key point: FDA accepted an sBLA for BCG-unresponsive NMIBC with papillary disease without CIS and set a PDUFA date of 06 Jan 2027.
Implication: May expand screening, initiation, and follow-up at scale.
🧬 Enhertu CHMP opinion in HER2-positive solid tumours [9] [EU • 22 May 2026]
https://www.astrazeneca.com/media-centre/press-releases/2026/enhertu-recommended-in-eu-for-her2-solid-tumours.html
Context: AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) is a HER2-directed DXd ADC evaluated across DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02.
Key point: CHMP recommended Enhertu monotherapy for previously treated unresectable or metastatic HER2-positive solid tumours with no satisfactory options.
Implication: May influence prescriber choice and payer reviews pending full data.
🧬 Alecensa Japan approval in ALK-positive solid tumours [10] [Japan • 18 May 2026]
https://www.chugai-pharm.co.jp/english/news/detail/20260518153001_1249.html
Context: Chugai’s Alecensa (alectinib) is an ALK inhibitor already used in ALK-positive NSCLC and recurrent or refractory ALK-positive anaplastic large cell lymphoma.
Key point: Japan’s MHLW approved Alecensa for advanced or recurrent ALK fusion-positive solid tumours, including pediatric patients, based on the TACKLE study.
Implication: Introduces competition that may affect pricing and formulary access.
Why it matters
- Precision oncology is driving the week’s regulatory activity, with EGFR, HER2, ALK, ESR1, TROP2, PD-1, and Nectin-4 linked updates.
- ADCs remain central, with Trodelvy, Datroway, Enhertu, and Padcev involved in breast, bladder, and tumour-agnostic settings.
- Breast cancer updates span TNBC, ER-positive disease, and HER2-positive solid tumour biology.
- Lung cancer updates continue to segment by biomarker and histology, including HER2-mutated NSCLC, EGFR L858R NSCLC, and sqNSCLC.
- Bladder cancer activity is moving across both muscle-invasive and non-muscle-invasive disease settings.
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FAQ
What changed for Lantern Pharma’s LP-300 program?
Lantern said FDA raised no objections to HARMONIC amendments that enrich for EGFR exon 21 L858R, extend LP-300 dosing, and move the trial to a single-arm design. [1]
Is Bayer’s HYRNUO approved for first-line HER2-mutated NSCLC?
No. Bayer said FDA granted Priority Review for the first-line sNDA, but HYRNUO is not currently approved in that setting. [2]
How do Trodelvy and Datroway differ in these TNBC updates?
Trodelvy received a CHMP positive opinion in the EU, while Datroway received FDA approval in the US for 1L metastatic TNBC patients not eligible for PD-1/PD-L1 inhibitors. [4], [5]
What is the regulatory status of AstraZeneca’s camizestrant in Europe?
CHMP recommended camizestrant plus a CDK4/6 inhibitor for ER-positive, HER2-negative advanced breast cancer with emergent ESR1 mutation. [6]
What is the regulatory status of KEYTRUDA plus Padcev in EU MIBC?
CHMP recommended the regimen as perioperative treatment for cisplatin-ineligible resectable MIBC. European Commission review is next. [7]
What is notable about Chugai’s Alecensa approval?
Chugai said Japan’s MHLW approved Alecensa for ALK fusion-positive solid tumours, including pediatric patients. [10]
Entities / Keywords
Lantern Pharma, LP-300, HARMONIC, EGFR exon 21 L858R, never-smoker NSCLC
Bayer, HYRNUO, sevabertinib, HER2-mutated NSCLC, SOHO-01
Henlius, serplulimab, Hetronifly, sqNSCLC, CHMP
Gilead, Trodelvy, sacituzumab govitecan, ASCENT-03, metastatic TNBC
AstraZeneca, Daiichi Sankyo, Datroway, datopotamab deruxtecan, TROPION-Breast02
AstraZeneca, camizestrant, SERENA-6, ESR1 mutation, ER-positive breast cancer
Merck/MSD, KEYTRUDA, pembrolizumab, Padcev, enfortumab vedotin, KEYNOTE-905, EV-303, MIBC
ImmunityBio, ANKTIVA, nogapendekin alfa inbakicept, BCG, NMIBC, QUILT-3.032
AstraZeneca, Daiichi Sankyo, Enhertu, trastuzumab deruxtecan, HER2-positive solid tumours
Chugai, Alecensa, alectinib, ALK fusion-positive solid tumours, TACKLE, MHLW
References
- https://ir.lanternpharma.com/news-1/news/news-details/2026/Lantern-Pharma-Announces-Successful-Outcome-of-FDA-Type-C-Meeting-Request-for-HARMONIC-Phase-2-Trial-of-LP-300-in-Never-Smokers-with-NSCLC/default.aspx
- https://www.bayer.com/en/us/news-stories/new-drug-application-for-hyrnuo
- https://www.henlius.com/en/NewsDetails-5939-26.html
- https://www.gilead.com/news/news-details/2026/gilead-receives-chmp-positive-opinion-for-trodelvy-in-first-line-metastatic-triple-negative-breast-cancer-for-patients-not-candidates-for-pd-l1-inhibitors
- https://www.astrazeneca.com/media-centre/press-releases/2026/datroway-approved-in-us-for-1l-triple-negative-bc.html
- https://www.astrazeneca.com/media-centre/press-releases/2026/camizestrant-recommended-for-breast-cancer-in-eu.html
- https://www.merck.com/news/merck-receives-positive-eu-chmp-opinion-for-keytruda-pembrolizumab-plus-padcev-enfortumab-vedotin-ejfv-as-perioperative-treatment-for-adults-with-cisplatin-ineligible-resectable-muscle/
- https://immunitybio.com/immunitybio-announces-fda-acceptance-of-supplemental-bla-for-anktiva-plus-bcg-in-bcg-unresponsive-non-muscle-invasive-bladder-cancer-with-papillary-disease-pdufa-date-set-for-january-6-2027/
- https://www.astrazeneca.com/media-centre/press-releases/2026/enhertu-recommended-in-eu-for-her2-solid-tumours.html
- https://www.chugai-pharm.co.jp/english/news/detail/20260518153001_1249.html