ASCO Updates: RemeGen, Genentech, Johnson & Johnson, Bristol-Myers Squibb and Bayer


As the American Society of Clinical Oncology (ASCO) Annual Meeting winds down, here’s a look at some of Monday’s top stories.

RemeGen, a China-based biotech company, presented data on RC48 at ASCO for second-line urothelial cancer. This treatment was already approved for human trials in China. A company spokesperson told BioSpace, “RC48 combines an antibody that targets a specific protein on the surface of tumor cells with a payload of chemotherapy that penetrates and kills cancer cells. Having higher affinity to HER2 means that RC48 is better internalized by the tumor cell, which has translated into higher response rates in patients. For patients with advanced bladder cancer who’ve been previously treated with immunotherapy and chemotherapy, current treatment options are extremely limited, and this higher response rate is extremely encouraging.”

For patients, this means the antibody drug-conjugate RC48 is better at finding and killing cancer cells and can deliver benefit to patients who might have less HER2 expression compared to lower affinity antibodies. In the trial, the drug showed rapid tumor shrinkage in patients with advanced bladder cancer who were previously treated with immunotherapy and chemotherapy.

Asked by BioSpace as to the status of approval in China and the U.S., the company stated, “We are committed to delivering treatment to patients as soon as possible. We believe our data represents a significant advancement for the patients, families, caregivers and healthcare professionals who need more options for the medical management of this hard-to-treat cancer and look forward to ongoing discussions with Chinese and U.S. health officials.”

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Genentech, a Roche company, announced data from its Impower150 Phase III trial. The trial looked at a combination of Tecentriq, Avastin, carboplatin and paclitaxel in chemotherapy-naïve, metastatic non-squamous non-small cell lung cancer (NSCLC) patients. The combination showed an overall survival (OS) advantage in baseline liver metastases compared to a combination of Avastin alone with chemotherapy.

Amgen presented the first clinical data from a Phase I trial of AMG 510, the first KRAS G12C inhibitor to hit the clinic. There were no dose-limiting toxicities reported. The drug also showed anti-tumor activity as a monotherapy in patients with locally-advanced or metastatic KRASG12C mutant solid tumors.

“KRAS has been a target of active exploration in cancer research since it was identified as one of the first oncogenes more than 30 years ago,” stated Amgen’s David M. Reese, executive vice president of Research and Development, “but it remained undruggable due to a lack of traditional small molecule binding pockets on the protein. AMG 510 seeks to crack the KRAS code by exploiting a previously hidden groove on the protein surface.”

Johnson & Johnson’s Janssen Pharmaceutical presented long-term follow-up data from two pivotal Phase III trials of Imbruvica (ibrutinib) in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), a type of non-Hodgkin lymphoma. The results from the RESONATE trial had a median follow-up of 65.3 months and showed that Imbruvica alone sustained progression-free survival (PFS) benefit compared to ofatumumab in previously treated CLL/SLL, with a median PFS of 44.1 months compared to 8.1 months, respectively. The second data was from the RESONATE-2 trial at median follow-up of five years. RESONATE-2 showed durable PFS with Imbruvica monotherapy compared to chlorambucil, 70% compared to 12%, respectively.

Bristol-Myers Squibb announced updated results from trials looking at Opdivo (nivolumab) and Yervoy (ipilimumab), alone or in combination, in advanced or metastatic melanoma. First, a five-year analysis of the Phase I CA209-004 trial, the longest follow-up for Opdivo plus Yervo in patients with previously treated or untreated advanced melanoma. With a median follow-up of 43.1 months in all patients, at four years or longer, overall survival (OS) was stable at 57%.

Second, the Phase III CheckMate -067 study, which explored the long-term quality of life (QoL) and symptom burden. The study found that QoL was maintained during a treatment-free interval (TFI) in patients with previously untreated unresectable or metastatic melanoma after discontinuing of treatment with Opdivo or Opdivo plus Yervoy. A four-year analysis of the study also found that the drugs alone or in combination in patients with untreated unresectable or metastatic melanoma showed QoL and symptoms maintained from baseline during extended treatment.

Bayer presented new data on Vitrakvi (larotrectinib) in adults and children with TRK fusion cancer and primary central nervous system (CNS) tumors or brain metastases. The data included 14 patients with primary CNS tumors, including cases of glioma, glioblastoma, glioneural tumors, and astrocytoma. In the group, Vitrakvi showed an overall response rate (ORR) of 36%, including 14% complete responses (CR) and 21% partial responses (PR). The remaining 64% had stable disease. No patients showed signs of progressive disease as based on best response investigator assessment using RANO (Response Assessment in Neuro-Oncology) and RECIST 1.1 (Response Evaluation Criteria In Solid Tumors). In five patients with NTRK gene fusion positive solid tumors with brain metastases, the ORR was 60%.

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