Sanrisso (rilertinib) / Nanjing Sanhome Pharma - LARVOL DELTA

Cost-effectiveness of rilertinib versus osimertinib in second-line treatment in EGFR T790M resistance mutation advanced non-small cell lung cancer in China. (PubMed, Front Pharmacol) - "PSA showed rilertinib's cost-effective probabilities were 51.6% at one-time GDP per capita and 90.2% at three-times GDP per capita ($40,334.05) WTP threshold. From a Chinese healthcare system perspective, second-line treatment of EGFR T790M resistance mutation advanced NSCLC with rilertinib may have cost-effectiveness compared with osimertinib."

HEOR • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Cost-effectiveness of Rilertinib Versus Osimertinib in Second-line Treatment in EGFR T790M Resistance Mutation Advanced Non-Small Cell Lung Cancer in China (Frontiers) - "The incremental life-years (LYs) and quality-adjusted life years (QALYs) for the rilertinib group versus the osimertinib group were 0.34 and 0.30, respectively. The total cost for the rilertinib group was $3,774.60 higher than that for the osimertinib group. The incremental cost-effectiveness ratio (ICER) for rilertinib group compared with osimertinib group was $12,786.08, which is lower than one time the GDP per capita ($13,444.68)."

HEOR • Non Small Cell Lung Cancer

A Phase III Study of Rilertinib Versus Gefitinib as First-Line Therapy for Patients with Locally Advanced or Metastatic EGFR-Mutated NSCLC (IASLC-WCLC 2024) - P3 | "Conclusions : Rilertinib is a well-tolerated third-generation EGFR-TKI that demonstrated superior efficacy compared with gefitinib in first-line treatment for patients with EGFR mutation-positive NSCLC, along with an acceptable safety profile without new signals. Rilertinib could serve as a new treatment option for this population."

Clinical • Metastases • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

China clinical practice guideline for epidermal growth factor receptor tyrosine kinase inhibitors in stage â…£ non-small cell lung cancer (version 2023) (PubMed, Zhonghua Yi Xue Za Zhi) - "As of August 23, 2023, the first generation EGFR-TKIs, gefitinib, icotinib, and erlotinib; the second generation EGFR-TKIs, afatinib and dacomitinib; and the third generation EGFR-TKIs, osimertinib, almonertinib, furmonertinib and befotertinib were all approved for marketing by China National Medical Products Administration (NMPA). In addition, multiple domestic third-generation EGFR-TKIs are undergoing clinical trials, such as rezivertinib (BPI-7711), limertinib (ASK120067), and oritinib (SH-1028). Meanwhile, mobocertinib and sunvozertinib, which targets EGFR 20ins mutations, were also approved by NMPA. With the increasing variety of EGFR-TKIs approved for marketing subsequently, it brings confusion to clinicians when choosing specific medications, and there is an urgent need to develop relevant treatment guidelines. Hence, the Medical Oncology Branch of China International Exchange and Promotive Association for Medical and Health Care and the Chinese Association for..."

Clinical guideline • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • EGFR

SH-1028 Tablets Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB NSCLC With Sensitizing EGFR Mutations (clinicaltrials.gov) - P3 | N=242 | Recruiting | Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd.

New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Drug-drug interaction potential of SH-1028, a third-generation EGFR-TKI: in vitro and clinical trials. (PubMed, Invest New Drugs) - "A phase I drug-drug interaction study in healthy volunteers was performed to evaluate the impact of co-administering rifampicin (a strong CYP3A4 inducer) and itraconazole (a strong CYP3A4 inhibitor) on the pharmacokinetics of SH-1028. In the clinical application of SH-1028, special attention should be paid to the interaction between SH-1028 and drugs or foods that affect the activity of CYP3A4. (Clinical trial registration number: CTR20210558)."

Journal • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CYP1A2

Safety, efficacy, and pharmacokinetics of SH-1028 in EGFR T790M-positive advanced non-small cell lung cancer patients: A dose-escalation phase 1 study. (PubMed, Cancer) - "Lung cancer has a high morbidity and mortality, with an estimated 1.8 million deaths in 2020. Non-small cell lung cancer accounts for approximately 85% of lung cancer. First- or second-generation EGFR TKIs' weak selectivity often led to the occurrence of treatment-related adverse events, such as interstitial lung disease, rash, diarrhea, etc., along with acquired drug resistance within approximately 1 year. A dose of 200 mg of SH-1028 once daily showed a preliminary antitumor activity with manageable safety in patients with EGFR T790M mutation."

Journal • Metastases • P1 data • PK/PD data • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • EGFR

Development and validation of an LC-MS/MS method for simultaneous determination of SH-1028, an irreversible third-generation EGFR TKI, and two of its metabolites in human plasma: application in clinical pharmacokinetics. (PubMed, Xenobiotica) - "After multiple-dose administration, SH-1028 exhibited a slight accumulation, with a mean accumulation ratio (R) of 2.00.4. The study assessed the PK properties of SH-1028 following single and multiple doses in patients with advanced NSCLC and would provide meaningful information for the further development of SH-1028."

Journal • PK/PD data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Oritinib (SH-1028), a third-generation EGFR tyrosine kinase inhibitor in locally advanced or metastatic NSCLC patients with positive EGFR T790M: results of a single-arm phase II trial (ELCC 2022) - P2 | "No interstitial lung disease were reported. Conclusions Oritinib demonstrated potential clinical benefit and tolerable in advanced NSCLC patients with EGFR T790M mutation."

Clinical • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

And Still They Come Over Troubled Waters: Can Asia's Third-Generation EGFR Tyrosine Kinase Inhibitors (Furmonertinib, Aumolertinib, Rezivertinib, Limertinib, Befotertinib, SH-1028, and Lazertinib) Affect Global Treatment of EGFR+ NSCLC. (PubMed, J Thorac Oncol) - No abstract available

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Efficacy and safety of SH-1028 in patients with EGFR T790M positive non-small-cell lung cancer: a multicenter, single-arm, open-label, phase 2 trial. (PubMed, J Thorac Oncol) - P2 | "SH-1028 is efficacious and tolerable in second-line treatment of advanced NSCLC patients with positive EGFR T790M."

Journal • P2 data • Dermatology • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • EGFR

Beyond osimertinib: The development of 3-generation EGFR Tyrosine Kinase Inhibitors. (PubMed, J Thorac Oncol) - P3 | "In this review, we profiled many of the third-generation EGFR TKIs in late stage clinical development (e.g. almonertinib, lazertinib, alflutinib, rezivertinib, ASK120069, SH-1028, D-0316 and abivertinib) of their interim results of phase 1-3 trials and their chemical structures when publicly available. Additionally, we summarized the results of clinical trials that previously reported third-generation EGFR TKIs (rociletinib, olmutinib, nazartinib, maverlertinib) including phase 3 results of rociletinib and naquotinib. We further profiled the next-generation combination clinical trial design of third-generation EGFR TKIs including FLAURA2 (NCT04035486), MARIPOSA (NCT04487080), ACROSS1 (NCT04500704) and ACROSS2 (NCT04500717)."

Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

[VIRTUAL] Oritinib (SH - 1028), a Third - generation EGFR - TKI in Advanced NSCLC Patients with Positive EGFR T790M: Results of a Single - arm Phase Ib Trial (IASLC-WCLC 2021) - P2 | "Conclusion Oritinib demonstrated potential clinical benefit in advanced NSCLC patients with EGFR T790M mutation following prior therapy with EGFR TKIs. The phase II study (n=220 patients) is ongoing to confirm these findings."

Clinical • P1 data • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • EGFR

SH-1028, An Irreversible Third-Generation EGFR TKI, Overcomes T790M-Mediated Resistance in Non-Small Cell Lung Cancer. (PubMed, Front Pharmacol) - "Both SH-1028 and osimertinib have a pyrimidine structure (a typical mutant-selective EGFR TKI structure). The main metabolite of SH-1028, Imp3, was tested and showed no wild-type EGFR inhibition or off-target effects. In conclusion, SH-1028 is a new third-generation EGFR inhibitor that exhibits potent activity against EGFR sensitive and resistant (T790 M) mutations."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

The Absorption, Metabolism and Excretion of [14C]SH-1028 in Chinese Healthy Male Volunteers (clinicaltrials.gov) - P1; N=6; Completed; Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd.

Clinical • New P1 trial

The Effect of Itraconazole and Rifampicin on the Pharmacokinetics of SH-1028 (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd.

Clinical • New P1 trial

A Study of SH-1028 Tablets Versus Gefitinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov) - P3; N=240; Not yet recruiting; Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd.

Clinical • New P3 trial • EGFR

A Study to Evaluate the Safety and Efficacy of SH-1028 in Locally Advanced or Metastatic NSCLC (clinicaltrials.gov) - P2; N=300; Not yet recruiting; Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd.

Clinical • New P2 trial

Safety and Tolerability of SH-1028 in Patients With Advanced Solid Cancer (clinicaltrials.gov) - P1; N=14; Not yet recruiting; Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd.

Clinical • New P1 trial

Safety and Tolerability of SH-1028 in Patients With Advanced Solid Cancer (clinicaltrials.gov) - P1; N=14; Recruiting; Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd.; Trial primary completion date: Dec 2018 ➔ Dec 2019

Clinical • Trial primary completion date

Safety, Tolerability and Pharmacokinetics of SH-1028 in Patients With Advanced NSCLC (clinicaltrials.gov) - P1; N=85; Recruiting; Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd.; Trial primary completion date: Dec 2018 ➔ Dec 2019

Clinical • Trial primary completion date

Safety, Tolerability and Pharmacokinetics of SH-1028 in Patients With Advanced NSCLC (clinicaltrials.gov) - P1; N=85; Recruiting; Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd.

Clinical • New P1 trial

Newly added product (clinicaltrials.gov) - Non-small Cell Lung Cancer, Phase 2

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