US pharmaceutical giant Gilead announced on Monday that its anti-cancer drug Trodelvy failed to significantly improve survival rates in a trial of advanced lung cancer patients, causing its stock price to drop by over 10%.
This California based pharmaceutical company tested Trodelvy in patients with squamous and non squamous non-small cell lung cancer (the most common type of lung cancer). Gilead stated in a statement that the difference in survival between patients receiving Trodelvy treatment and those receiving chemotherapy alone is not statistically significant and does not meet the criteria for trial success.
This is a blow for Gilead, as the company is striving to become an important player in the cancer field, with Trodelvy being one of Gilead's best-selling anti-cancer drugs. Gilead stated that he plans to discuss the results with regulatory agencies and submit complete data at the upcoming medical conference.
According to the American Society of Clinical Oncology, by 2023, approximately 230000 adults in the United States will be diagnosed with lung cancer, with non-small cell lung cancer accounting for 81% of all diagnosed cases.
Trodelvy, an antibody coupled drug (ADC), has been approved for the treatment of certain types of breast cancer and bladder cancer. In the first nine months of last year, it brought Gilead a revenue of 765 million dollars.
Antibody conjugated drugs are a targeted anti-cancer therapy that is likened to "guided missiles". As the name suggests, each ADC consists of three parts: specific antibodies, highly efficient cytotoxic agents, and conjugates that connect the two. By specifically recognizing antigens on the surface of tumor cells, ADCs can accurately deliver toxins to cancer cells while reducing damage to normal cells.
ADC is also one of the most popular fields in the pharmaceutical industry. At the beginning of this month, Johnson&Johnson announced to acquire Ambrx Biopharma with 2 billion dollars in pure cash. Because Ambrx currently has many ADC research projects, involving prostate cancer, breast cancer, renal cell cancer and other aspects.
BMO Capital Markets analyst Evan Seigerman stated that these data have raised doubts about Trodelvy's use as a second-line treatment. However, he added that Trodelvy still has the opportunity to occupy a portion of the market share as an initial treatment drug for non-small cell lung cancer.
Jefferies analysts said that the failure of the Trodelvy trial was not entirely surprising, as data from other similar drugs in early studies was mixed. However, this trial failure is another blow to the drug's development plan and may reduce investor confidence in Gilead's sales of anti-cancer drugs.
At the same time, Gilead has also reached an agreement with Merck to conduct global phase 2 and phase 3 clinical trials of Trodelvy in combination with Keytruda as first-line treatment for metastatic non-small cell lung cancer patients.
Merdad Parsey, Chief Medical Officer of Gilead, stated that the Phase 3 first-line trial is currently recruiting patients and results cannot be obtained "for at least a few years". "The latest data makes us continue to believe in Trodelvy's potential in metastatic non-small cell lung cancer, as well as our broader lung cancer clinical development projects."
In September 2020, Geely made a big bet by announcing the acquisition of biotech company Immunomedicine for $21 billion, accelerating its expansion in the cancer field. We hope that the latter's Trodelvy will become a best-selling anti-cancer drug, diversifying Gilead's sources of income.