A checkpoint inhibitor under development from China’s CStone Pharmaceuticals hit the mark in a Phase III non-small cell lung cancer study.
A checkpoint inhibitor under development from China’s CStone Pharmaceuticals hit the mark in a Phase III non-small cell lung cancer study. The company reported that sugemalimab met its endpoint of overall survival in front-line treatment of metastatic NSCLC.
CStone reported that data from the GEMSTONE-302 registrational clinical study of sugemalimab combined with chemotherapy showed statistically significant and clinically meaningful OS improvement in patients. In a previous study, sugemalimab also hit the mark in progression-free survival. Based on that data, the National Medical Products Administration (NMPA) of China approved sugemalimab combined with chemotherapy for the first-line treatment of patients with metastatic squamous and non-squamous NSCLC in December 2021.
“After being approved in China last month and with the first batch of prescriptions issued recently, now the OS analysis of the GEMSTONE-302 study demonstrated that sugemalimab in combination with chemotherapy brought significant improvement to the overall survival of patients even with high percentage of patients in the chemotherapy control group received subsequent PD-1/PD-L1 inhibitors, including crossover treatment based on the protocol design, after disease progression,” Dr. Jason Yang, chief medical officer of CStone Pharmaceuticals said in a statement. “As OS represents the gold standard efficacy endpoint in cancer clinical trials, the achievement of the OS endpoint further demonstrates the important value of sugemalimab in the first-line treatment of NSCLC.”
Sugemalimab is a PD-(L)-1 monoclonal antibody addressing stage III and stage IV NSCLC in all-comer settings.
CStone wasn’t the only company to post positive cancer data this week. Several other companies also reported impressive news.
Celucity – Minnesota-based Celucity’s lead drug candidate, gedatolisib, was granted Fast Track designation by the U.S. Food and Drug Administration to treat patients with HR+/HER2- metastatic breast cancer after progression on CDK4/6 therapy. Celucity reported that it remains on track to receive feedback from the FDA and to finalize the design and protocol of its Phase III clinical trial in the first quarter of 2022. Additionally, the company said it plans to begin two Phase II clinical trials assessing gedatolisib in HR+/HER2- breast cancer patients selected with a CELsignia PI3K Pathway Test. One trial will study gedatolisib in combination with fulvestrant in up to 25 patients with metastatic breast cancer. The second trial will study up to 15 patients diagnosed with early-stage breast cancer, evaluating gedatolisib in combination with palbociclib and letrozole.
ImmunityBio – California’s ImmunityBio announced interim results from its Phase II QUILT 88 study assessing overall survival in metastatic pancreatic cancer. The study is assessing the combination treatment that includes ImmunityBio’s IL-15 receptor agonist Anktiva, its off-the-shelf targeted natural killer cells (PD-L1 t-haNK), and aldoxorubicin, an albumin-modulated agent, plus low-dose chemotherapy. The combination has been dubbed the Nant Cancer Vaccine.
To date, 27% of third-line or greater patients remain on study. The median overall survival in this advanced group of patients, all of whom failed two to six prior lines of treatment, is 5.8 months. The interim data shows that patients treated with its combination immunotherapy saw overall survival rates for patients doubled compared to the historical survival rate of three months after two prior lines of therapy. Based on these findings, ImmunityBio said it intends to meet with the FDA later this year to discuss the path for the approval of combination therapies for pancreatic cancer.
The Phase II data also shows that serious adverse events related to the treatment were low.
HutchMed – China’s HutchMed announced it would present an updated analysis of the ongoing Phase I/Ib trial of fruquintinib Saturday at the 2022 ASCO Gastrointestinal Cancers Symposium. Fruquintinib is a highly selective and potent oral inhibitor of VEGFR-1, -2 and -3. The company is assessing the drug in refractory metastatic colorectal cancer, the third most common cancer globally.
Merck – Merck’s vaunted checkpoint inhibitor Keytruda has hit the mark again in the Phase III KEYNOTE-394 trial assessing Keytruda, plus best supportive care (BSC) in patients in Asia with advanced hepatocellular carcinoma (HCC) previously treated with the chemotherapy drug, sorafenib. Data showed that Keytruda, as a second-line monotherapy, improved overall survival, progression-free survival and objective response rate in these patients.
Merck said Keytruda demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of OS, reducing the risk of death by 21% compared to placebo and BSC. The median OS for Keytruda patients was 14.6 months, slightly longer than the 13 months for patients on placebo plus BSC. The percentage of patients who were alive at two years was 34.3% for the Merck drug compared to 24.9% for placebo. Full data will be presented later this week at ASCO GI.
In the U.S., KEYTRUDA has been approved under accelerated approval for treating patients with HCC who have been previously treated with sorafenib based on ORR and duration of response data from KEYNOTE-224. According to the company, data from KEYNOTE-394 will be evaluated as a potential confirmatory study in the U.S.
