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Savolitinib: First Approval

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Abstract

Savolitinib (Orpathys®; HUTCHMED, AstraZeneca) is a receptor tyrosine kinase mesenchymal epithelial transition factor (MET) inhibitor being developed for the treatment of metastatic non-small cell lung cancer (NSCLC), papillary and clear cell renal cell carcinoma (RCC), gastric cancer and colorectal cancer. Based on the results of a pivotal phase II trial in patients with NSCLC/pulmonary sarcomatoid carcinoma, savolitinib was recently granted approval in China (conditional on the results of a phase III trial) for the treatment of metastatic NSCLC with MET exon 14-skipping alterations in patients who have progressed after or who are unable to tolerate platinum-based chemotherapy. This article summarizes the milestones in the development of savolitinib leading to this first approval.

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References

  1. Comoglio PM, Giordano S, Trusolino L. Drug development of MET inhibitors: targeting oncogene addiction and expedience. Nat Rev Drug Discov. 2008;7(6):504–16.

    Article  CAS  PubMed  Google Scholar 

  2. Hogan Lovells. China: progress on conditional approval and compassionate use of new drugs. 2018. https://www.engage.hoganlovells.com/knowledgeservices/news/the-china-food-and-drug-administration-pushes-forward-on-conditional-approval-and-compassionate-use-of-new-drugs. Accessed 10 Aug 2021.

  3. National Medical Products Administration. ORPATHYS: NMPA approval notice. 2021. https://www.nmpa.gov.cn/yaowen/ypjgyw/20210623094324131.html. Accessed 10 Aug 2021.

  4. Hutchmed. Savolitinib: Chinese prescribing information. Shanghai: Hutchmed; 2021.

  5. Hutchison China MediTech Limited. HUTCHMED: Change of company name [media release]. 4 May 2021.

  6. Hutchison MediPharma, AstraZeneca. AstraZeneca and Hutchison Medi Pharma enter into global collaboration to co-develop and commercialize novel cancer therapy [media release]. 21 Dec 2011.

  7. Hutchinson China MediTech Limited, AstraZeneca. Chi-Med and AstraZeneca amend co-development agreement to accelerate savolitinib global development program [media release]. 1 Aug 2016.

  8. Gavine PR, Ren Y, Han L, et al. Volitinib, a potent and highly selective c-Met inhibitor, effectively blocks c-Met signaling and growth in c-MET amplified gastric cancer patient-derived tumor xenograft models. Mol Oncol. 2015;9(1):323–33.

    Article  CAS  PubMed  Google Scholar 

  9. Ding Q, Ou M, Zhu H, et al. Effect of food on the single-dose pharmacokinetics and tolerability of savolitinib in Chinese healthy volunteers. Fundam Clin Pharmacol. 2021. https://doi.org/10.1111/fcp.12697.

    Article  PubMed  Google Scholar 

  10. Lu S, Fang J, Li X, et al. Once-daily savolitinib in Chinese patients with pulmonary sarcomatoid carcinomas and other non-small-cell lung cancers harbouring MET exon 14 skipping alterations: a multicentre, single-arm, open-label, phase 2 study. Lancet Respir Med. 2021. https://doi.org/10.1016/S2213-2600(21)00084-9.

    Article  PubMed  PubMed Central  Google Scholar 

  11. Han J, Sequist L, Ahn M, et al. Osimertinib + savolitinib in pts with EGFRm MET-amplified/overexpressed NSCLC: phase Ib TATTON parts B and D final analysis [abstract no. FP14.03]. J Thorac Oncol. 2021;16(Suppl 3):S227–8.

    Article  Google Scholar 

  12. Choueiri TK, Heng DYC, Lee JL, et al. Efficacy of savolitinib vs sunitinib in patients with MET-driven papillary renal cell carcinoma: The SAVOIR phase 3 randomized clinical trial. JAMA Oncol. 2020;6(8):1247–55.

    Article  PubMed  Google Scholar 

  13. Choueiri TK, Plimack E, Arkenau HT, et al. Biomarker-based phase II trial of savolitinib in patients with advanced papillary renal cell cancer. J Clin Oncol. 2017;35(26):2993–3001.

    Article  CAS  PubMed  Google Scholar 

  14. Rodriguez CS, Larkin J, Patel PM, et al. Clinical activity of durvalumab and savolitinib in MET-driven, metastatic papillary renal cancer [abstract no. 4511]. J Clin Oncol. 2021;39(Suppl 15).

  15. Pal SK, Tangen C, Thompson IM Jr, et al. A comparison of sunitinib with cabozantinib, crizotinib, and savolitinib for treatment of advanced papillary renal cell carcinoma: a randomised, open-label, phase 2 trial. Lancet. 2021;397(10275):695–703.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  16. Lee J, Kim ST, Kim K, et al. Tumor genomic profiling guides patients with metastatic gastric cancer to targeted treatment: the VIKTORY umbrella trial. Cancer Discov. 2019;9(10):1388–405.

    CAS  PubMed  Google Scholar 

  17. Oxnard GR, Cantarini M, Frewer P, et al. SAVANNAH: a phase II trial of osimertinib plus savolitinib for patients (pts) with EGFR-mutant, MET-driven (MET+), locally advanced or metastatic non-small cell lung cancer (NSCLC), following disease progression on osimertinib [abstract no. TPS9119]. J Clin Oncol. 2019;37(Suppl 15).

  18. Hutchison China MediTech Limited. Chi-Med announces progress in savolitinib lung cancer program and update on kidney cancer strategy [media release]. 20 Dec 2018.

  19. Jia J, Niedzwiecki D, Arrowood C, et al. A phase II study of savolitinib (volitinib, AZD6094, HMPL-504) in subjects with MET amplified metastatic colorectal cancer (mCRC) detected by cell-free (cf)DNA [abstract no. TPS270]. J Clin Oncol. 2020;38(Suppl 4).

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  1. Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand

    Anthony Markham

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  1. Anthony Markham
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Correspondence to Anthony Markham.

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The preparation of this review was not supported by any external funding.

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During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. A. Markham is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

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This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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Markham, A. Savolitinib: First Approval. Drugs 81, 1665–1670 (2021). https://doi.org/10.1007/s40265-021-01584-0

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