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Drugmakers unveil new clinical data at US cancer meet
  • By Nam Doo-hyun
  • Published 2018.06.08 14:41
  • Updated 2018.06.08 14:41
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Korean and global pharmaceutical companies disclosed their newest clinical data on anticancer pipelines at the American Society of Clinical Oncology conference, which ran from Friday to Tuesday in Chicago, the U.S.

Ono Pharma Korea and Bristol-Myers Squibb Korea Pharmaceutical on Monday announced partial results of their phase-3 study CheckMate-227 on Opdivo (ingredient: nivolumab), an anticancer treatment.

The annual meeting of the American Society of Clinical Oncology (ASCO), the world’s largest cancer research conference, was held in Chicago, the U.S., from Friday to Tuesday.

The Part 1b of the study compared Opdivo plus low-dose Yervoy and Opdivo plus chemotherapy with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) with PD-L1 expression less than 1 percent.

The latest trial was the first to check both the combination of two immuno-oncology therapies and the combination of immunotherapy-chemotherapy.

The results showed that in patients with the high tumor mutational burden (TMB), the one-year progression-free survival (PFS) rate was 45 percent with Opdivo plus low-dose Yervoy, which was more than five times higher than that of chemotherapy. Opdivo plus chemotherapy showed higher response rate at 60.5 percent.

“Opdivo plus chemotherapy improved progression-free survival versus chemotherapy in first-line lung cancer patients whose tumors do not express PD-L1,” said Hossein Borghaei, study investigator and chief of thoracic medical oncology at Fox Chase Cancer Center in Philadelphia.

Taken together with the totality of CheckMate-227 data presented to date, Opdivo plus low-dose Yervoy therapy had a long-term efficacy in patients with high TMB, he added.

On Sunday, Abbvie revealed the results of combination therapy using Imbruvica (ibrutinib) with Venclexta (venetoclax) in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients with no treatment experiences.

The phase-2 study showed 77 percent of 30 patients did not develop a minimal residual disease (MRD) after six cycles of the combo therapy. At the 12th cycle, 90 percent of the 14 patients achieved responses with no detectable MRD, with 93 percent showing MRD negativity in a peripheral blood test and 86 percent, in a bone marrow test.

Danelle James, head of clinical science at Pharmacyclics, a subsidiary of Abbvie, said the findings well demonstrated “potential benefit of combining the two agents with complementary mechanisms of action.”

He added that the combo treatment could be one step closer to cure lymphocytic leukemia.

Germany’s Merck also presented many clinical results, boasting abundant anticancer pipelines.

Merck’s disclosures include Erbitux (cetuximab) data related to head and neck squamous cell carcinoma, data on Bavencio (avelumab) in patients with metastatic Merkel cell carcinoma, additional efficacy data of the dual-acting immunotherapy fusion protein M7824 for NSCLC and data on low-molecular drug Tepotinib for NSCLC.

Merck hopes its latest clinical data will reaffirm Erbitux’ status as the standard therapy to treat metastatic colorectal cancer and metastatic squamous cell carcinoma in head and neck. Also, the company’s data on avelumab from the two-year results of JAVELIN Merkel 200 trial drew attention as the first study to report long-term survival data for immunotherapy in metastatic Merkel cell carcinoma.

Korean pharmaceutical firms also joined the event to open their latest clinical data.

Samsung Bioepis announced the one-year follow-up study results after the completion of the breast cancer therapy SB3 (trastuzumab). The company published the results of the first year out of the five-year follow-up research on the homepage of the ASCO.

According to the results, SB3 showed 96.7 percent survival rate, a similar level to the original Herceptin’s 94.3 percent.

On the other hand, Genexine’s clinical results on the combination of Hyleukin-7 with Nekter’s IL-2 were not as good as anticipated, bringing down the company’s stock prices.

“Although the combo’s therapeutic effects were weaker in interim results than earlier, it is still more potent than monotherapy,” Genexine said. “We are still recruiting patients. As we will continue to announce accumulated clinical results, the final results of the drug candidate should be followed in the long-term.”

hwz@docdocdoc.co.kr

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