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23/06/2025 Datroway has been approved in the US for locally advanced or metastatic EGFR-mutated NSCLC ( Ref ) The US FDA approved AstraZeneca and Daiichi's datopotamab deruxtecan (Datroway; TROP2 ADC) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated NSCLC who have received prior EGFR-directed therapy and platinum-based chemotherapy. The indication is approved under accelerated approval based on ORR and DoR results from a subgroup analysis of the Phase 2 TROPION-Lung05 trial and supported by data from the Phase 3 TROPION-Lung01 trial. The approval follows a priority review and breakthrough therapy designation. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Daraxonrasib received the FDA Breakthrough Therapy Designation for previously treated metastatic pancreatic cancer with KRAS G12 mutations ( Ref ) The US FDA granted the Breakthrough Therapy Designation to Revolution Medicines' daraxonrasib (RAS(ON) multi-selective inhibitor) for previously treated metastatic PDAC in patients with KRAS G12 mutations. The designation has been granted based on encouraging data from the Phase 1 RMC-6236-001 trial of daraxonrasib in patients with previously treated metastatic PDAC. Revolution is currently conducting the Phase 3 RASolute 302 trial of daraxonrasib in patients with previously treated metastatic PDAC. The study design focuses on a core population of patients with RAS G12X mutations, and an expanded population of patients RAS G12X, G13X or Q61X mutations, or those without any identified targetable mutation. The dual primary endpoints for the study are PFS and OS in the core patient population.

22/06/2025 The Phase 3 STELLAR-303 trial of zanzalintinib + atezolizumab achieved significant OS benefit in metastatic colorectal cancer ( Ref ) Per topline results from the Phase 3 STELLAR-303/NCT05425940 pivotal trial, Exelixis' zanzalintinib (third-generation oral tyrosine kinase inhibitor) + Roche's atezolizumab (aPD-L1) demonstrated a statistically significant improvement in OS vs regorafenib in previously treated, non-microsatellite instability (MSI)-high metastatic colorectal cancer (CRC) These findings are from the final analysis conducted by the Independent Data Monitoring Committee of one of the dual primary endpoints of OS in the ITT population of all randomized patients, regardless of the presence of liver metastases. The trial will proceed to the planned final analysis for the other dual primary endpoint of OS in patients without liver metastases (non-liver metastases, NLM). The safety profiles of zanzalintinib + atezolizumab and of regorafenib were generally consistent with what has been previously observed, and no new safety signals were identified. Exelixis will be discussing the findings with regulatory authorities and presenting the detailed results at an upcoming medical conference.

19/06/2025 Initial patient screening completed in Transgene's Phase 2 trial of TG4050 vaccine in resectable SCCHN ( Ref ) Transgene completed the initial patient screening in the randomized Phase 2 part of its Phase 1/2 TG4050.02/NCT04183166 trial evaluating TG4050 (individualized neoantigen vaccine) mono as an adjuvant Tx of HPV-ve SCCHN In Ph1 part of the trial, the vaccine elicited promising outcomes with a 2-yr DFS rate of 100.0% Transgene expects to complete randomization of all patients in the Phase 2 part by end-2025, following a second screening of patients conducted after surgery and adjuvant chemo ± radiotherapy First Phase 2 immunogenicity data are expected by H2'26, and preliminary efficacy data by H2'27

18/06/2025 The Phase 3 IDeate-Prostate01 trial of ifinatamab deruxtecan has been initiated in pretreated, metastatic CRPC patients ( Ref ) The first patient has been dosed in the Phase 3 IDeate-Prostate01/NCT06925737 trial evaluating Daiichi Sankyo and Merck & Co./MSD's ifinatamab deruxtecan (I-DXd; B7-H3 ADC) vs docetaxel in patients with metastatic castration-resistant prostate cancer (CRPC) with disease progression during or after treatment with an androgen receptor pathway inhibitor. This multicenter, open-label, randomized trial will enroll ~1,440 patients and evaluate OS and radiographic PFS as the primary endpoints Mark Rutstein, Head, Therapeutic Area Oncology Development, Daiichi Sankyo: “ Despite the emergence of new therapies, the current treatment landscape for patients with metastatic castration-resistant prostate cancer is challenging, and there is a need for new treatments. Following the promising results seen in our earlier phase trial, IDeate-Prostate01 has been initiated to evaluate whether ifinatamab deruxtecan may replace standard taxane-based chemotherapy as a potential treatment strategy in patients with metastatic castration-resistant prostate cancer with disease progression during or after treatment with androgen receptor pathway inhibitors .” Marjorie Green, SVP and Head of Oncology, Global Clinical Development, Merck Research Laboratories: “IDeate-Prostate01 marks the initiation of the third pivotal trial in the ifinatamab deruxtecan development program and reinforces our commitment to addressing critical unmet needs for patients. Our continued progress in the exploration of this potential first-in-class B7-H3 antibody drug conjugate in collaboration with Daiichi Sankyo, speaks to our pursuit of novel science in the hopes of making a difference for patients in need of new options.”

June 2nd Week, 2025 Regulatory Events   🎯 The US FDA approved Merck & Co./ MSD 's pembrolizumab (anti-PD-1) mono Q3W, 2Cy, as a neoadjuvant Tx followed by adjuvant pembro Q3W, 3Cy + RT ± cisplatin after surgery, then pembro mono Q3W, 12Cy, for adults with resectable locally advanced SCCHN with PD-L1 CPS ≥1. (Ref 1)  ❓ What were the factors that influenced the FDA’s decision to limit the label to PD-L1 CPS ≥1?  🎯 The US FDA approved  Nuvation Bio ’s taletrectinib (ROS1 inhibitor) for the Tx of adult patients with locally advanced or metastatic ROS1+ve NSCLC. (Ref 2)  ❓ How is this approval going to impact the Tx paradigm of ROS1+ve NSCLC?  🎯 The US FDA approved  UroGen Pharma ’s Zusduri (mitomycin and sterile hydrogel) for the Tx of adults with recurrent Low-Grade Intermediate-Risk NMIBC. (Ref 3)  ❓ What are the key unmet needs of recurrent LG-IR-NMIBC?  🎯 The US FDA approved  BeOne Medicines ’ new tablet formulation of zanubrutinib (small molecule inhibitor of BTK) for all five previously approved indications. (Ref 4)  ❓ What are the pros and cons of the tablet formulation of zanubrutinib?    Special Designations   ⭐ The US FDA accepted  Jazz Pharmaceuticals ’ sNDA for lurbinectedin (DNA alkylating agent) +  Roche ’s atezolizumab (anti-PD-L1) as a first-line maintenance Tx for extensive-stage SCLC patients whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin, and etoposide for Priority Review, with a PDUFA action date of Oct 7, 2025. (Ref 5)  ❓ What are the clinical outcomes of the combination that support the priority review? ⭐ The US FDA granted Fast Track Designation to  Cantargia AB ’s nadunolimab (anti-IL1RAP) + gemcitabine and nab-paclitaxel for the Tx of patients with previously untreated metastatic pancreatic ductal adenocarcinoma with high IL1RAP expression. (Ref 6)  ❓ How do the outcomes of the combination compare against the current benchmarks?  ⭐ The US FDA granted Fast Track Designation to  Radiopharm Theranostics ’ RAD101 (imaging small molecule targeting FASN) to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin including leptomeningeal disease. (Ref 7)  ❓ Who are the other key players with assets that have received the FTD for the imaging of brain metastases?  To know answers to these questions and for additional insights, write to us at  support@oncofocus.com .  🌐 References:  1) https://www.merck.com/news/fda-approves-keytruda-pembrolizumab-for-pd-l1-resectable-locally-advanced-head-neck-squamous-cell-carcinoma-as-neoadjuvant-treatment-continued-as-adjuvant-treatment-combined-with-radiother/ 2) https://investors.nuvationbio.com/news/news-details/2025/U-S--Food-and-Drug-Administration-Approves-Nuvation-Bios-IBTROZI-taletrectinib-a-Next-Generation-Oral-Treatment-for-Advanced-ROS1-Positive-Non-Small-Cell-Lung-Cancer/default.aspx 3) https://investors.urogen.com/news-releases/news-release-details/us-fda-approves-urogens-zusduritm-mitomycin-intravesical 4) https://ir.beonemedicines.com/news/us-fda-approves-tablet-formulation-of-beones-brukinsar-for-all-approved-indications/644dc063-4114-48b8-9636-c60cb6cc6bd1 5) https://investor.jazzpharma.com/news-releases/news-release-details/zepzelcar-lurbinectedin-and-atezolizumab-tecentriqr-combination 6) https://cantargia.com/en/press-releases/cantargias-nadunolimab-antibody-awarded-us-fda-fast-track-designation 7) https://www.biospace.com/press-releases/radiopharm-theranostics-granted-u-s-food-and-drug-administration-fast-track-designation-for-rad101-imaging-in-brain-metastases

June 1st Week, 2025 Regulatory Events 🎯  Takeda  and  Pfizer ’s brentuximab vedotin (Adcetris; CD30 ADC) + ECADD chemo regimen has been approved by the European commission for the Tx of adult patients with newly diagnosed stage IIb with risk factors/III/IV Hodgkin lymphoma. (Ref 1)  ❓ Can brentuximab-based regimen be the standard of care? What are its strengths and limitations?   🎯  Tempest Therapeutics ’ amezalpat (selective PPAR⍺ antagonist) has been granted an Orphan Drug Designation (ODD) by the European Medicines Agency (EMA) for the Tx of hepatocellular carcinoma. (Ref 2)  ❓ What are the current Tx strategies and recent therapeutic advancements in HCC?   🎯  Innovent Biologics ' IBI363 (PD-1 x IL-2α-bias BsAb fusion protein) has been granted a Breakthrough Therapy Designation by China's NMPA for the Tx of LA/M squamous NSCLC patients who have progressed on prior PD-(L)1 and platinum-based chemotherapy. (Ref 3)  ❓ How do IBI363’s clinical efficacy compare with that of approved regimens? Can it be an acquisition target?  Clinical Developments   🔬 The Ph3 HARMONi trial of  Summit Therapeutics, Inc.  and  Akeso Biopharma ’s ivonescimab (PD-1 x VEGF BsAb) + platinum-doublet chemotherapy in EGFR+ve non-squamous NSCLC patients who have progressed on a 3rd gen-TKI demonstrated a statistically significant and clinically meaningful improvement in PFS. (Ref 4)  ❓ What is the expected regulatory timeline for ivonescimab’s approval in the US and Europe?    Mergers & Collaborations   🤝  Vividion Therapeutics, Inc. , a wholly owned and independently operated subsidiary of  Bayer  AG, acquired exclusive worldwide development and commercialization rights for VVD-214 (RO7589831; Werner helicase inhibitor), which was co-developed by Vividion and  Roche . (Ref 5)  ❓ What is the projected revenue potential for VVD-214?  To know answers to these questions and for additional insights, write to us at  support@oncofocus.com . 🌐 References:  1) https://www.takeda.com/newsroom/newsreleases/2025/europe-adcetris-approval/ 2) https://ir.tempesttx.com/news-releases/news-release-details/tempest-receives-orphan-drug-designation-european-medicines 3) https://www.innoventbio.com/InvestorsAndMedia/PressReleaseDetail?key=538 4) https://www.smmttx.com/wp-content/uploads/2025/05/2025_PR_0530-_-HARMONi-Data-_-FINAL.docx.pdf 5) https://vividion.com/news/vividion-therapeutics-and-bayer-further-strengthen-oncology-development-pipeline-with-clinical-stage-wrn-inhibitor/

May 5th Week, 2025 Regulatory Events 🎯 The EC approved  Bristol Myers Squibb ’s subcutaneous nivolumab (Opdivo Quantig; anti-PD-1) co-formulated with  Halozyme, Inc. ’s recombinant human hyaluronidase (rHuPH20) for use across multiple adult solid tumors as monotherapy, monotherapy maintenance following completion of nivolumab + ipilimumab IV, or in combination with chemotherapy or cabozantinib. (Ref 1) ❓ What is the development status of other key subcutaneous immune checkpoint inhibitors? Special Designations ⭐ The US FDA granted the Priority Review status to  Bayer ’s sevabertinib (HER2 & EGFR TKi) for the Tx of HER2+ve NSCLC, who have received a prior systemic therapy. (Ref 2) ❓ What is the estimated launch timeline for sevabertinib? ⭐ Singapore's  Experimental Drug Development Centre (EDDC)  EBC-129 (CEACAM5 & CEACAM6 ADC) has been granted the Fast Track designation by the US FDA for the Tx of pancreatic ductal adenocarcinoma (PDAC). (Ref 3) ❓ What are the clinical outcomes that support the designation? ⭐ Shanghai  Henlius ’ AC101/HLX22 (anti-HER2) has been granted the Orphan Drug Designation by the EC for the Tx of gastric cancer. (Ref 4) HLX22 was originally developed through a discovery collaboration between  Alligator Bioscience AB ’s subsidiary, Atlas Therapeutics, and  AbClon . ❓ What is the current development status of HLX22 in this indication? Setbacks 🛑  Daiichi Sankyo US  and Merck & Co./ MSD  voluntarily withdrew the BLA seeking accelerated approval of patritumab deruxtecan (HER3 ADC) in the US for EGFR mutated NSCLC patients previously treated with at least 2 systemic therapies due to the failure in meeting statistically significant OS in the Phase 2 HERTHENA-Lung01 trial. (Ref 5) ❓ How is this failure of patritumab deruxtecan going to impact its overall development status? 🛑  Adlai Nortye ’s Phase 3 BURAN trial of buparlisib (PI3K inhibitor) + paclitaxel did not meet the primary endpoint of OS vs paclitaxel alone in recurrent and metastatic HNSCC patients that have progressed after anti-PD-(L)1-based treatment. (Ref 6) ❓ What are the possible reasons for failure of the regimen in this indication? To know answers to these questions and for additional insights, write to us at  support@oncofocus.com . 🌐 References: 1) https://news.bms.com/news/details/2025/Bristol-Myers-Squibb-Receives-European-Commission-Approval-for-the-Subcutaneous-Formulation-of-Opdivo-nivolumab-Across-Multiple-Solid-Tumor-Indications/default.aspx 2) https://www.bayer.com/media/en-us/sevabertinib-bay-2927088-granted-fda-priority-review-for-the-treatment-of-patients-with-her2-mutant-non-small-cell-lung-cance r/ 3) https://www.eddc.sg/experimental-drug-development-centre-granted-u-s-fda-fast-track-designation-for-antibody-drug-conjugate-ebc-129-to-treat-pancreatic-ductal-adenocarcinoma/ 4) https://alligatorbioscience.se/en/mfn_news/alligator-bioscience-announces-european-orphan-drug-designation-for-hlx22-in-gastric-cancer/ 5) https://www.merck.com/news/patritumab-deruxtecan-biologics-license-application-for-patients-with-previously-treated-locally-advanced-or-metastatic-egfr-mutated-non-small-cell-lung-cancer-voluntarily-withdrawn/#:~:text=About%20EGFR%2DMutated%20Non%2DSmall%20Cell%20Lung%20Cancer&text=NSCLC%20accounts%20for%20about%2087,up%20to%2070%25%20of%20patients . 6) https://ir.adlainortye.com/news-releases/news-release-details/adlai-nortye-announces-topline-results-phase-iii-buran-trial

May 4th Week, 2025 Regulatory Events   🎯 The US FDA granted a Fast Track designation to  CSPC Pharmaceutical Group  ’s CPO301 (SYS6010; EGFR ADC) for the Tx of oncogenic driver mutation negative, non-squamous NSCLC patients who have progressed on prior platinum chemotherapy and anti-PD-(L)1 therapy. (Ref 1) ❓ Which other ADCs are being developed for this setting?   🎯  Zai Lab 's ZL-1310 (DLL3 ADC) was granted a Fast Track designation by the US FDA for the Tx of ES-SCLC patients who have progressed on prior platinum-based chemotherapy. (Ref 2) ❓ What is the current SoC for ES-SCLC Tx?   🎯 The EMA granted a pediatric study waiver to  Alligator Bioscience AB ’ mitazalimab (CD40 agonist) for the Tx of pancreatic cancer. (Ref 3) ❓ How do pediatric study waivers accelerate timelines for therapies like mitazalimab?   🎯 China’s NMPA approved  Jacobio Pharma ’s glecirasib (KRAS G12C inhibitor), which was outlicensed to  Shanghai Allist Pharmaceuticals Co., Ltd  in China, for the Tx of KRAS G12C mutated NSCLC patients who have progressed on at least one prior systemic therapy. (Ref 4) ❓ How does it compare against other approved assets in this setting? Clinical Events   🔬 The Ph3 TALENTACE trial of  Roche ’s atezolizumab (Tecentriq; anti-PD-L1) + Roche’s bevacizumab (Avastin; anti-VEGF) + on-demand transarterial chemoembolization (TACE) in previously untreated HCC patients, conducted by  Chugai Pharmaceutical Co., Ltd.  in China and Japan, met its primary endpoint of TACE PFS. (Ref 5) ❓ Is a similar treatment regimen currently being investigated in global clinical trials? Deals & Collaborations 🤝 In >$6.0 billion deal ($1.25 upfront),  Pfizer  gained global (ex-China) rights for  3SBio Inc. ’s SSGJ-707 (PD-1 x VEGF BsAb) (Ref 6) ❓ What clinical data are available for SSGJ-707, and how do its outcomes compare to other PD-1 x VEGF BsAbs? 🤝  Antengene  and Merck & Co/ MSD  entered into a global clinical collaboration agreement to evaluate Antengene's ATG022 (CLDN18.2 ADC) in combination with Merck & Co/MSD’s pembrolizumab (Keytruda; anti-PD-1) in advanced solid tumors. (Ref 7) ❓ What are the potential therapeutic indications for this regimen? To know answers to these questions and for additional insights, write to us at  support@oncofocus.com . 🌐 References: 1) https://doc.irasia.com/listco/hk/cspc/announcement/a250519b.pdf 2) https://ir.zailaboratory.com/news-releases/news-release-details/zai-lab-receives-us-fda-fast-track-designation-zl-1310-dll3 3) https://alligatorbioscience.se/en/mfn_news/alligator-bioscience-announces-paediatric-study-waiver-for-mitazalimab-granted-by-the-european-medicines-agency/ 4) https://www.jacobiopharma.com/en/news/glecirasib_China_NDA 5) https://www.chugai-pharm.co.jp/english/news/detail/20250521173000_1161.html?year=2025&category= 6) https://www.pfizer.com/news/press-release/press-release-detail/pfizer-enters-exclusive-licensing-agreement-3sbio 7) https://www.antengene.com/static/upload/sofa/20250520/a50aba484d6e6314814d746ad705d0f3.pdf

May 3rd Week, 2025 Regulatory Events   🎯  Incyte  and  MacroGenics, Inc. ’s retifanlimab (anti-PD-1) + carboplatin + paclitaxel has been approved by the US FDA for the first-line Tx of inoperable, locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). Retifanlimab has also been approved as a single agent for the Tx of locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemo. (Ref 1)  ❓ What is the status of the other anti-PD-1 based regimens in this cancer type? 🎯  AbbVie ’s telisotuzumab vedotin (anti- c-Met ADC) has been granted accelerated approval by the US FDA for the Tx of locally advanced or metastatic, non-squamous NSCLC with high c-Met protein overexpression, and who have received a prior systemic Tx. (Ref 2)  ❓ How will this approval impact the Tx paradigm of the indication?    Clinical Events   🔬 The Phase 3 KEYNOTE-B96 trial of Merck & Co./ MSD ’s pembrolizumab (anti-PD-1) + chemo ± bevacizumab met its primary endpoint of PFS for the Tx of platinum-resistant recurrent ovarian cancer patients whose tumors expressed PD-L1 and in all comers, and secondary endpoint of OS in patients whose tumors express PD-L1. (Ref 3)  ❓ What are the current PFS and OS benchmarks in this indication?   🔬 The Phase 3 RC48-C016 trial of  Pfizer  and  RemeGen Biosciences ’ disitamab vedotin (anti-HER2 ADC) + toripalimab (anti-PD-1) met its primary endpoints of PFS and OS vs chemotherapy as a first-line Tx for HER2+ve, locally advanced or metastatic, urothelial carcinoma. (Ref 4)  ❓ Which are the other anti-HER2 ADCs being developed for this indication?  Special Designations   ⭐ The US FDA granted the orphan drug designation to  Thermosome ’s THE001 (thermosensitive liposomal formulation of doxorubicin) for the treatment of soft tissue sarcomas. (Ref 5)  ❓ What are the key unmet needs of patients with soft tissue sarcomas?  Setbacks   🛑  iTeos Therapeutics  and  GSK  terminated the belrestotug (anti-TIGIT) development program and ended their collaboration based on disappointing results from the Ph2 GALAXIES Lung-201 and the Ph2 GALAXIES H&N-202 trials. (Ref 6)  ❓ Which other anti-TIGIT agents continue to be evaluated in solid tumors?  To know answers to these questions and for additional insights, write to us at  support@oncofocus.com   🌐 References:  1) https://investor.incyte.com/news-releases/news-release-details/incyte-announces-fda-approval-zynyzr-retifanlimab-dlwr-making-it 2) https://news.abbvie.com/2025-05-14-U-S-FDA-Approves-EMRELIS-TM-telisotuzumab-vedotin-tllv-for-Adults-With-Previously-Treated-Advanced-Non-Small-Cell-Lung-Cancer-NSCLC-With-High-c-Met-Protein-Overexpression 3) https://www.merck.com/news/merck-announces-phase-3-keynote-b96-trial-met-primary-endpoint-of-progression-free-survival-pfs-in-patients-with-platinum-resistant-recurrent-ovarian-cancer-whose-tumors-expressed-pd-l1-and-in-all-c/ 4) https://www.remegen.com/index.php?v=show&cid=115&id=2596 5) https://finance.yahoo.com/news/thermosome-receives-u-orphan-drug-080000546.html 6) https://investors.iteostherapeutics.com/news-releases/news-release-details/iteos-reports-topline-interim-results-galaxies-lung-201-study

May 2nd Week, 2025 Special Designations ⭐ The US FDA granted the Fast Track designation to  Adcentrx Therapeutics ’ ADRX-0706 (Nectin-4 ADC) for the Tx of locally advanced or metastatic squamous cell cervical cancer. (Ref 1)  ❓ What are the outcomes of ADRX-0706 that supported the Fast Track designation? ⭐ The US FDA granted the Fast Track designation to  Glenmark Pharmaceuticals  (Ichnos Glenmark Innovation)’s ISB2001 (BCMA x CD38 x CD3 trispecific antibody) for the Tx of R/R multiple myeloma patients who have received ≥3 prior lines of Tx including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 mAb. (Ref 2)  ❓ What are the key competitors' drugs that have also received the Fast Track designation in this setting? ⭐ The US FDA granted the Fast Track designation to  ITALFARMACO S.P.A. ’s givinostat (HDAC inhibitor) for the Tx of polycythemia vera. (Ref 3)  ❓What are the key unmet needs for patients with polycythemia vera?    Clinical Events     🔬 The Phase 3 DESTINY-Breast11 trial of  AstraZeneca  and  Daiichi Sankyo ’s trastuzumab deruxtecan (HER2 ADC) followed by paclitaxel, trastuzumab and pertuzumab achieved a statistically significant pCR rate as a neoadjuvant Tx vs SOC in high-risk, HER2+ve, early-stage breast cancer. (Ref 4)  ❓What is the current benchmark for pCR in this indication?  🔬 In the Phase 2b TACTI-003 trial,  Immutep Limited 's eftilagimod alfa (soluble LAG-3 protein) +  MSD /Merck&Co’s pembrolizumab (anti-PD-1) achieved a mOS of 17.6 mos as a first-line Tx of recurrent or metastatic HNSCC with PD-L1 CPS <1. (Ref 5)  ❓What are the other LAG-3 agents being evaluated as a first-line Tx for SCCHN? To know answers to these questions and for additional insights, write to us at  support@oncofocus.com   🌐 References:  1) https://www.adcentrx.com/adcentrx-therapeutics-granted-fast-track-designation-adrx-0706/ 2) https://iginnovate.com/2025/05/03/ichnos-glenmark-innovation-igi-receives-usfda-fasttrack-designation-for-isb-2001-for-relapsed-refractory-multiple-myeloma/ 3) https://www.globenewswire.com/news-release/2025/05/06/3074789/0/en/Italfarmaco-Announces-U-S-FDA-Grants-Fast-Track-Designation-to-Givinostat-in-Treatment-of-Polycythemia-Vera.html 4) https://www.astrazeneca.com/media-centre/press-releases/2025/enhertu-improved-pcr-in-early-stage-breast-cancer.html 5) https://www.immutep.com/detail/immutep-s-efti-in-combination-with-keytruda-r-pembrolizumab-drives-strong-overall-survival-in-head-and-neck-cancer-with-cps-1.html

May 1st Week, 2025 Regulatory Events   🎯  Summit Therapeutics, Inc.  and  Akeso Biopharma ’s ivonescimab (PD-1 x VEGF BsAb) mono has been approved in China for the 1L Tx of NSCLC with PD-L1 ≥1%. (Ref 1)  ❓ When can we expect ivonescimab to receive the first approval in the key markets?   🎯 The UK’s MHRA approved  Bristol Myers Squibb ’s nivolumab (anti-PD-1) subcutaneous formulation for a broad range of cancers, including kidney, melanoma, lung, head and neck, bladder, colorectal, liver, stomach, and cancers of the oesophagus. (Ref 2)  ❓ What are the other subcutaneous formulations of immune checkpoint inhibitors under development?  Special Designation   ⭐The US FDA granted the Fast Track designation for  BioInvent International AB ’s BI-1808 (anti-TNFR2) for the Tx of R/R mycosis fungoides and Sézary syndrome. (Ref 3)  ❓ What are the outcomes of BI-1808 that supported the Fast Track designation?   ⭐ The US FDA granted the Fast Track designation for  Incyclix Bio ’s INX-315 (CDK2 inhibitor) for the Tx of CCNE1-amplified platinum-R/R ovarian cancer. (Ref 4)  ❓ What are the key competitor drugs that have also received the Fast Track designation in this setting?  ⭐ The US FDA granted the Breakthrough Device Designation for  Roche ’s VENTANA TROP2 (EPR20043) RxDx Device making it the first among the computational pathology companion diagnostic devices. (Ref 5)  ❓ Which are the other companies developing similar diagnostic devices?  Clinical Events   🔬In the Phase 3 CREST trial,  Pfizer ’s sasanlimab (anti-PD-1) + BCG (induction and maintenance) met its primary endpoint of EFS vs BCG alone (induction and maintenance) in BCG-naïve, high-risk NMIBC. However, interim OS data suggested no difference between the Tx arms. (Ref 6)  ❓ Does the combo have the potential to become the SOC based on the EFS benefit?   🔬The Phase 2/3 KN026-001 trial of  Alphamab Oncology  and  CSPC Pharmaceutical Group  ’s KN026 (anti-HER2 BsAb) + chemotherapy met the primary endpoint of PFS as a ≥ 2L Tx of HER2+ve gastric or gastroesophageal junction cancer. (Ref 7)  ❓ What are the current PFS benchmarks for this indication?  Setbacks   🛑  AstraZeneca  discontinued the Phase 3 CAPItello-280 trial of capivasertib (ATP-competitive inhibitor) + docetaxel + ADT vs placebo + docetaxel + ADT in metastatic CRPC as it was unlikely to meet the dual primary endpoints of rPFS and OS. (Ref 8)  ❓ What are the other key Phase 3 trials ongoing in this indication?  To know answers to these questions and for additional insights, write to us at  support@oncofocus.com   🌐 References:  1) https://www.akesobio.com/en/media/akeso-news/250426/ 2) https://www.gov.uk/government/news/mhra-authorises-cancer-treatment-variation-with-an-administration-time-of-3-5-minutes 3) https://www.bioinvent.com/en/press/bioinvent-receives-fda-fast-track-designation-bi-1808-treatment-cutaneous-t-cell-lymphoma 4) https://incyclixbio.com/news_releases/incyclix-bio-granted-u-s-fda-fast-track-designation-for-inx-315-to-treat-ccne1-amplified-platinum-resistant-refractory-ovarian-cancer/ 5) https://www.roche.com/media/releases/med-cor-2025-04-29 6) https://www.pfizer.com/news/press-release/press-release-detail/pfizers-sasanlimab-combination-significantly-improves-event 7) https://www.alphamabonc.com/en/html/news/2669.html 8) https://www.astrazeneca.com/media-centre/press-releases/2025/update-on-capitello-280-phase-iii-trial.html

April 4th Week, 2025 Regulatory & Market News 🎯  Akeso Biopharma ’s penpulimab-kcqx (anti-PD-1) + chemo received the US FDA approval for the Tx of previously untreated recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (nkNPC). 👉 The FDA also approved single agent penpulimab-kcqx for the Tx of nkNPC patients who have progressed following platinum chemo and at least one other prior line of therapy. (Ref 1) ❓ How does this approval affect the current Tx landscape of NPC? 🎯  Bristol Myers Squibb ’s nivolumab (Opdivo; anti-PD-1) + BMS’ ipilimumab (Yervoy; anti-CTLA-4) received the NICE recommendation for reimbursement for the Tx of patients with previously untreated MSI-H/dMMR metastatic/unresectable Colorectal Cancer (CRC) (Ref 2) ❓ How would this impact other companies looking to enter CRC space? 🎯  Daiichi Sankyo  filed a supplemental NDA to Japan’s MHLW for extension of trastuzumab deruxtecan’s (Enhertu; HER2 ADC) indication to include solid tumors that are HER2 overexpressed (IHC 3+) or amplified (ERBB2) and are refractory or intolerant to standard treatments. (Ref 3) ❓ Are there any tumor-agnostic treatments approved in Japan currently? Clinical Updates 🔬 Per interim analysis of the Ph3 DESTINY-Breast09 trial,  AstraZeneca  and Daiichi Sankyo’s trastuzumab deruxtecan (Enhertu; HER2 ADC) +  Roche ’s pertuzumab (Perjeta; anti-HER2/neu) demonstrated statistically significant and clinically meaningful improvement in PFS vs THP (taxane, trastuzumab and pertuzumab) in patients with previously untreated HER2+ Breast Cancer. (Ref 4) ❓What is the current benchmark for PFS in HER2+ Breast Cancer? 🔬 In a China-specific Ph3 AK112-306/HARMONi-6 trial, Akeso BioPharma and  Summit Therapeutics, Inc. 's ivonescimab (PD-1 x VEGF BsAb) + chemo met primary endpoint of PFS vs  BeiGene 's tislelizumab (anti-PD-1) + chemo as a first-line Tx in advanced squamous NSCLC. (Ref 5) ❓ When are the results of the first global Phase 3 trial of ivonescimab in NSCLC expected to be available? 🔬 In a Ph3 ASCENT-04/KEYNOTE-D19 trial,  Gilead Sciences  's sacituzumab govitecan-hziy (Trodelvy; TRP2 ADC) + Merck&Co/ MSD 's pembrolizumab (Keytruda; anti-PD-1) demonstrated statistically significant and clinically meaningful improvement in PFS vs pembrolizumab + chemo in patients with previously untreated, locally advanced or metastatic, PD-L1+ (CPS ≥ 10) TNBC. 👉 Additionally, an early trend in improvement for OS (key secondary endpoint) was observed in sacituzumab Tx arm (Ref 6) ❓ Can the sacituzumab + pembro regimen become a new standard of care? 🌐 References: 1) https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-penpulimab-kcqx-non-keratinizing-nasopharyngeal-carcinoma 2) https://www.thepharmaletter.com/nice-recommends-nhs-use-of-opdivo-and-yervoy-combo-for-mcrc 3) https://www.daiichisankyo.com/files/news/pressrelease/pdf/202504/20250424_E.pdf 4) https://www.astrazeneca.com/media-centre/press-releases/2025/enhertu-combination-improved-pfs-in-1l-her-positive-mbc.html 6) https://www.akesobio.com/en/media/akeso-news/250423/ 7) https://www.gilead.com/news/news-details/2025/trodelvy-plus-keytruda-demonstrates-a-statistically-significant-and-clinically-meaningful-improvement-in-progression-free-survival-in-patients-with-previously-untreated-pd-l1-metastatic-trip