Lartruvo (olaratumab) / Eli Lilly - LARVOL DELTA

Role of PROs in HTA and Reimbursement Decisions Across UK, Germany, France, Italy, and Spain (ISPOR-EU 2025) - "In Germany, crizotinib's positive benefit rating was supported by robust PRO data (EORTC QLQ-C30, EQ-5D), while regorafenib's absence of robust PRO evidence downgraded its rating from "minor added benefit" to "no proven added benefit". UK's NICE cited PROs as pivotal in positive appraisals of pemetrexed and roflumilast, referencing significant improvements in symptom scales and quality-of-life...France's HAS rejected olaratumab and avelumab due to lack of robust PROs, but supported dupilumab and onasemnogene abeparvovec, where validated PROs and caregiver-reported outcomes strengthened value claims... PROs are increasingly integrated into HTA submissions across EU4 + UK, yet their impact on reimbursement varies. Methodological rigor, validated instruments, and disease context remain critical for influencing positive decisions."

Reimbursement • US reimbursement • Rheumatology

CARDIOTOXICITY AND OVERALL SURVIVAL IN PATIENTS WITH SARCOMA TREATED WITH DOXORUBICIN, OLARATUMAB AND DEXRAZOXANE: A REAL-WORLD EXPERIENCE IN DENMARK (CTOS 2025) - "Administering dexrazoxane with doxorubicin in the first treatment cycle showed no statistically significant reduction in cardiotoxicity and improvement in OS. Further data from a larger retrospective study are pending."

Clinical • Real-world • Real-world evidence • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

TIME TOXICITY AND EFFECT OF CHEMOTHERAPY FOR PATIENTS WITH METASTATIC SOFT TISSUE SARCOMA - A RETROSPECTIVE REAL-WORLD STUDY OF 244 PATIENTS (CTOS 2025) - "Of these, 153 received doxorubicin with dexrazoxane, 47 received doxorubicin with olaratumab, and 44 received doxorubicin monotherapy. This study provides novel and comprehensive data on survival outcomes and treatment efficacy in patients with metastatic STS. Importantly, our findings underscore that a substantial proportion of patients' remaining lifespan is spent attending hospital, emphasizing the need to consider time toxicity in treatment decisions and shared clinical decision-making."

Metastases • Real-world • Real-world evidence • Retrospective data • Leiomyosarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Maintenance after first-line treatment for advanced soft tissue sarcoma. (PubMed, Crit Rev Oncol Hematol) - "Among seven trials assessing continuation maintenance therapy, two demonstrated significant improvement in progression-free survival (PFS): trabectedin following doxorubicin/trabectedin treatment in patients with advanced/metastatic leiomyosarcoma and anlotinib following epirubicin/anlotinib treatment across all histological subtypes. One trial investigating switch maintenance with regorafenib reported significant improvement in PFS in patients with nonadipocytic STS...Promising results observed with olaratumab in a randomized phase II trial were not confirmed in a subsequent phase III trial. Early phase trials involving doxorubicin/trabectedin in patients with liposarcoma, doxorubicin/lurbinectedin in patients with leiomyosarcoma and those with liposarcoma, and doxorubicin/pembrolizumab revealed promising associations that warrant exploration in future randomized trials. For pembrolizumab, biomarkers for appropriate patient selection are lacking. This literature review..."

Journal • Review • Leiomyosarcoma • Liposarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

From Growth Factors to Structure: PDGF and TGF-β in Granulation Tissue Formation. A Literature Review. (PubMed, J Cell Mol Med) - "Strategies employing steroid agents and Mitomycin-C aim to mitigate ostium granulation. The potential use of PDGF receptor blockers, such as olaratumab, warrants further investigation for managing excessive granulation. In conclusion, PDGF and TGFβ emerge as critical regulators in granulation tissue formation, underscoring their significance in wound healing processes and offering avenues for therapeutic intervention."

Journal • Review • Fibrosis • Immunology • Ophthalmology • TGFB1

Real-world survival outcomes and MDM2 prevalence in US patients with metastatic dedifferentiated liposarcoma. (PubMed, Future Oncol) - "The most common first-line treatment was doxorubicin with olaratumab (23.5%). Median TTNT was 3.9 months for the full cohort and 4.8 months for the MDM2-amplified, TP53 WT subgroup. The descriptive analysis here contributes real-world data describing treatment patterns, biomarker status, and clinical outcomes for patients with DDLPS, an aggressive and poorly characterized form of LPS with limited treatment options."

Journal • Real-world evidence • Retrospective data • Liposarcoma • Oncology • Sarcoma • Solid Tumor • MDM2 • TP53

Anlotinib in combination with epirubicin followed by maintenance anlotinib versus placebo plus epirubicin as first-line treatment for advanced soft tissue sarcoma (STS): A randomized, double-blind, parallel-controlled, phase III study. (ASCO 2025) - P3 | "The phase 3 ANNOUNCE trial failed to demonstrate an overall survival (OS) benefit with olaratumab plus doxorubicin compared to doxorubicin. Anlotinib in combination with epirubicin followed by maintenance ALTN demonstrated a statistically significant and clinically meaningful PFS benefit compared to epirubicin alone in pts with previously untreated advanced STS, which could serve as a potential new first-line treatment for locally advanced or metastatic STS. The final OS outcomes are currently under ongoing follow-up."

Clinical • Combination therapy • Metastases • P3 data • Leiomyosarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Synovial Sarcoma

Industry promotion of oncology drugs with accelerated approval that failed confirmatory trials. (ASCO 2025) - "Pepaxto was excluded from our analysis as it had no reported payments on OpenPayments...Following announcement of negative postapproval confirmatory study results, average monthly payments received by all physicians increased for Marqibo (vinCRIStine sulfate) from $138 in the year preceding announcement to $164 during the period between announcement of negative results and market withdrawal, but decreased for Farydak (panobinostat) ($12,317 to $4,916), Blenrep (belantamab mafodotin) ($152,417 to $119,394), and Ukoniq (umbralisib) ($23,139 to $14,130). Lartruvo (olaratumab) and Aliqopa (copanlisib) had almost no payments after announcement of negative confirmatory study results. Industry payments for oncology drugs with accelerated approvals mostly decreased after announcement of negative confirmatory trial results; however, there was evidence of continued promotion for certain drugs until a request for voluntary withdrawal was made by FDA. This suggests that regulatory..."

Oncology

Chemotherapy in giant cell tumour of soft tissue: A case-series (Sarcoma-RC 2025) - "A patient received both doxorubicin and olaratumab first-line but progressed 1.3 months after. Legal entity responsible for the study The authors. Funding Has not received any funding."

Clinical • Giant Cell Tumor of Bone • Oncology • Sarcoma • Solid Tumor • Tenosynovial Giant Cell Tumor

ZOLAR: 89Zr-olaratumab Dosimetry in Participants With Soft Tissue Sarcoma (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Telix Pharmaceuticals (Innovations) Pty Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Aug 2024 ➔ Oct 2024 | Trial primary completion date: Dec 2025 ➔ Mar 2026

Enrollment open • Trial initiation date • Trial primary completion date • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • PDGFRA

THE ROLE OF SYSTEMIC TREATMENT IN ADVANCED SOLITARY FIBROUS TUMORS: EXPERIENCE AT A REFERRAL CENTER. (CTOS 2024) - "Limited data have suggested promising activity with the combination therapy of temozolomide/bevacizumab (TZ/BV), but the rarity of this tumor subtype limits the development of large, randomized trials...Other 1st-line therapies were anthracyclin-based regimens: doxorubicin/dacarbazine in 3 pts (18.7%), doxorubicin monotherapy in 2 pts (12.5%) and adriamicine/olaratumab in one patient...One patient received 1st-line TZ/BV, achieving PR with a TTP of 47 m. Trabectedin and gemcitabine/docetaxel were also given as 1st line in one patient each, both with PD as the best response...For second and subsequent lines, median GMI was as follows: 0,41 (0.12-1.9), GMI ≥1.33 in 1 of 4 pts for pazopanib; 1.25 (0.4-3.7), GMI ≥1.33 in 2 of 4 pts for gemcitabine-dacarbazine; 3.67 (0.44-12.84), GMI ≥1.33 in 3 of 4 pts for TZ/BV (although the only patient with GMI < 1.33 is still on treatment and non-progressive at the time of analysis)... This retrospective study suggests that systemic..."

Metastases • Oncology

Economic Evaluations and Health Economic Models of Soft Tissue Sarcomas: Systematic Literature Review From a European and North American Perspective (ISPOR-EU 2024) - "19 compared pharmaceutical therapies, the majority (n=18) investigated trabectedin, pazopanib or olaratumab. Although a fairly large number of publications are available on the economic evaluation of STS, these mostly focus on a narrow patient sub-group, not eligible for surgery. The applied methodology of modelling, especially for pharmaceuticals, is mostly simplified and universally used across different jurisdictions."

HEOR • Review • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

KEYNOTE-505: A Study of Olaratumab (LY3012207) Plus Pembrolizumab in Participants With Advanced or Metastatic Soft Tissue Sarcoma (clinicaltrials.gov) - P1 | N=41 | Completed | Sponsor: Eli Lilly and Company | Phase classification: P1a/1b ➔ P1

Metastases • Phase classification • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

ANNOUNCE: A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma (clinicaltrials.gov) - P3 | N=509 | Completed | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Completed

Metastases • Trial completion • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Osteosarcoma patient-derived orthotopic xenograft (PDOX) models for identification of novel and effective therapeutics. (ASCOBT 2024) - " Effective treatment for drug-resistant osteosarcoma includes regorafenib, as monotherapy, and temozolomide-irinotecan, trabectedin-irinotecan, sorafenib-everolimus, sorafenib-palbociclib, and olaratumab-doxorubicin-cisplatin, as combinations. Owing to the high concordance of drug efficacy between patients and their corresponding PDOX models, these models provide improved and personalized treatment options for patients with osteosarcoma. The patient does not need to suffer from the potential drug toxicity and morbidity of ineffective chemotherapies. In an era of growing promise of new treatment and precision medicine, PDOX models can offer a unique opportunity to provide specific and individualized therapy and novel therapeutic options for osteosarcoma patients."

Clinical • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

ZOLAR: 89Zr-olaratumab Dosimetry in Participants With Soft Tissue Sarcoma (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: Telix Pharmaceuticals (Innovations) Pty Ltd

New P1 trial • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • PDGFRA

What are the Optimal Systemic Treatment Options for Rhabdomyosarcoma? (PubMed, Curr Treat Options Oncol) - "Currently, multiagent chemotherapy comprising vincristine, actinomycin D, and ifosfamide/cyclophosphamide remains standard systemic treatment for rhabdomyosarcoma...Recent clinical studies have shown efficacies and safeties of temozolomide combined with vincristine/irinotecan, olaratumab combined with doxorubicin or vincristine/irinotecan, and long-term maintenance therapy. Furthermore, basic researches demonstrated new therapeutic targets. Future studies using these approaches are required to assess their clinical significances."

Journal • Review • Oncology • Rhabdomyosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Results of a Randomized, Double-Blind, Placebo-Controlled, Phase 1b/2 Trial of Nabpaclitaxel + Gemcitabine ± Olaratumab in Treatment-Naïve Participants with Metastatic Pancreatic Cancer. (PubMed, Cancers (Basel)) - "Olaratumab plus chemotherapy failed to improve the OS or PFS in participants with metastatic PDAC. There were no new safety signals."

Clinical • Journal • Metastases • P1/2 data • Fatigue • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Results of a Randomized, Double-Blind, Placebo-Controlled, Phase 1b/2 Trial of Nabpaclitaxel + Gemcitabine ± Olaratumab in Treatment-Naïve Participants with Metastatic Pancreatic Cancer (Multidisciplinary Digital Publishing Institute) - P1/2 | N=184 | NCT03086369 | Sponsor: Eli Lilly and Company | "In phase 1b, 22 participants received olaratumab at doses of 15 and 20 mg/kg with a fixed dose of nabpaclitaxel and gemcitabine. In phase 2, 159 participants were randomized to receive olaratumab 20 mg/kg in cycle 1 followed by 15 mg/kg in the subsequent cycles (n = 81) or the placebo (n = 78) on days 1, 8, and 15 of a 28-day cycle, plus nabpaclitaxel and gemcitabine. The primary objective of the trial was not met, with a median OS of 9.1 vs. 10.8 months (hazard ratio [HR] = 1.05; 95% confidence interval [CI]: 0.728, 1.527; p = 0.79) and the median progression-free survival (PFS) was 5.5 vs. 6.4 months (HR = 1.19; 95% CI: 0.806, 1.764; p = 0.38), in the olaratumab vs. placebo arms, respectively."

P1/2 data • Pancreatic Cancer

Best Overall Response-associated Signature to Doxorubicin in Soft Tissue Sarcomas: A Transcriptomic Analysis from ANNOUNCE. (PubMed, Clin Cancer Res) - "The refined REDSARC signature provides a potential tool to direct the application of doxorubicin in sarcomas and other malignancies. Validation and further refinement of the signature in other potentially subtype specific prospective cohorts is recommended."

Journal • Leiomyosarcoma • Liposarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Undifferentiated Pleomorphic Sarcoma

Leiomyosarcoma: Reviewing first-line options (Sarcoma-RC 2024) - "PFSl in different treatment lines: Doxorubicin (D): 8 months, Doxorubicin + dacarbazine(D+DTIC): 12 months, Doxorubicin+trabectedin(D+tra): 9 months, Epirubicin + ifosfamide (Epi+Ifo): 7 month, gemcitabine + docetaxel (Gem+Doc): 7 months and Doxorubicin + olaratumab (D+olara): 7 months, p=0,07. Limitation of retrospective assessment. Slight increase in progression-free survival comparing with the literature. Epi+Ifo should not be a standard option in leiomyosarcoma, as literature data show a low response and limited disease control."

Clinical • Ewing Sarcoma • Leiomyosarcoma • Oncology • Sarcoma • Solid Tumor

ANNOUNCE: A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma (clinicaltrials.gov) - P3 | N=509 | Active, not recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Dec 2024 ➔ Jul 2024

Metastases • Trial completion date • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

TOLERABILITY AND OUTCOMES FOR TREATMENT OF OLDER MYXOID LIPOSARCOMA POPULATION (CTOS 2023) - "Systemic therapies included: doxorubicin alone or in combination with ifosfamide, olaratumab, or mitomycin C/cisplatin; trabectedin, gemcitabine, ifosfamide/etoposide, nivolumab. MLPS is considered a chemotherapy and RT sensitive sarcoma subtype. In this cohort of pts age ≥70 yrs with MLPS, the majority received surgery with perioperative radiation therapy. Few pts received perioperative chemotherapy for localized high grade MLPS, precluding meaningful analysis."

Clinical • Liposarcoma • Oncology • Sarcoma • Solid Tumor

CHARACTERISTICS AND OUTCOMES FOR PATIENTS IN THE UNITED STATES WITH DEDIFFERENTIATED LIPOSARCOMA FROM A REAL-WORLD DATA SET (CTOS 2023) - "The most common 1L treatment was doxorubicin (doxo) with olaratumab (23.5%), followed by gemcitabine and cisplatin (15.7%)...In 2L, eribulin was the most common (21.9%), followed by gemcitabine (15.6%)... Patient demographics are consistent with a 2012 report on 208 patients from 11 institutions (10 European members of the Connective Tissue Cancers Network of Excellence and Memorial Sloan Kettering Cancer Center [New York, NY]); however, median OS observed is lower than the reported 15.2 months. For those receiving 1L doxo monotherapy or in combination, rwPFS was comparable to this report and to a 2017 report on 51 patients at MD Anderson Cancer Center (Houston, TX). These results may highlight an awareness gap between academic centers and community practices for treating DDLPS."

Clinical • Real-world • Real-world evidence • Liposarcoma • Oncology • Sarcoma • Solid Tumor • MDM2 • TP53

LASTING COMPLETE RESPONSE TO PEMBROLIZUMAB IN MISMATCH REPAIR DEFICIENT CARDIAC SARCOMA: A GENOMIC CHARACTERIZATION (CTOS 2023) - "We present the case of a 73-year-old woman with a mismatch repair deficient (MMRd) undifferentiated cardiac sarcoma, who achieved a complete and durable response with the anti-PD1 inhibitor pembrolizumab after the failure of standard treatment consisting of doxorubicin together with olaratumab. The genomic analysis of the cardiac UDS displayed several markers known to predict response to ICIs: the tumor harbored a high TMB (> 10 mutations/Mb) and a MMRd/MSI signature. Of note, inactivating mutations of both FAT1 and NOTCH2 have also been associated with ICI therapy response in epithelial tumors. Moreover, the tumor displayed an extensive infiltrate by CD8+ T cells, and PD-L1 was expressed in the tumor immune microenvironment."

Clinical • IO biomarker • Mismatch repair • Tumor mutational burden • Oncology • Sarcoma • Solid Tumor • CD8 • FAT1 • MDM2 • MSH2 • MSH6 • NOTCH2 • PMS2 • TMB • TP53