The trial failed in succession and BMS announced Opdivo's withdrawal from the field of small cell lung cancer treatment

BMS has announced that it has decided to withdraw the approval of Opdivo for the treatment of small cell lung cancer (SCLC) in the United States after communicating with the FDA.
August 2018, Opdivo became the first FDA-approved PD-1/L1 drug for small cell lung cancer.
the results of the CheckMate032 study at the time, or ORR (objective remission rate) in patients with relapsed or wide-term SCLC who received Opdivo reached 12 percent.
for patients who are effective in Opdivo treatment, most can get DOR (remission duration) of up to 17.9 months.
overall, patients received good resistance to Opdivo treatment.
, however, the drug failed to reach the main trial endpoint in two corroropirative studies in different treatment settings.
October 2018, BMS announced the failure of the Opdivo clinical trial CheckMate-331.
CheckMate-331 is a large Phase III clinical study that compares the efficacy of Opdivo with chemotherapy for second-line treatment of small cell lung cancer.
trial results showed that the total survival of patients in the Opdivo treatment group was even shorter than that of the chemotherapy group (7.5 months vs. 8.4 months), while the objective remission rate in the Opdivo group was only 14% and the medium non-progression survival was only 1.4 months.
, the objective remission rate of patients in the chemotherapy group reached 16%, with a medium progression-free survival of 3.8 months.
November 2018, the drug suffered another setback when the trial failed.
in the CheckMate-451 study of patients with a wide range of stageSCLC who did not develop the disease after first-line platinum chemotherapy, opdivo's treatment with the CTLA-4 inhibitor Yeervoy (ipilimumab) did not reach the main endpoint of the trial compared to the placebo.
trial results showed that opdivo and Yervoy combined treatments were worse than placebos.
after nine months of follow-up, the overall survival rate of patients in the combined therapy group did not have significantly longer results than in the placebo group.
survival rate of patients in the placebo group was 9.6 months, while the combined treatment was only 9.2 months.
addition to the combined treatment results, Opdivo monotherapy did not extend the overall survival of patients compared to placebo.
at the time, Opdivo's approval did help increase treatment options for small cell lung cancer patients in the United States.
about 84 percent of lung cancer patients in the United States are non-small cell lung cancer, while the rest are small cell lung cancer, according to the American Cancer Society.
the vast majority of patients with small cell lung cancer are diagnosed in a wide range of stages.
small cell lung cancer is likely to have spread widely by the time it is diagnosed, small cell lung cancer is often difficult to cure.
as Opdivo's multiple trials failed, industry insiders ben skeptical that the drug would continue to maintain the approval of small-cell lung cancer, raising concerns about the drug's prospects.
the FDA's goal in accelerating drug approval is to bring innovative drugs for serious illness to market more quickly.
approved in this way, it is important to demonstrate in future validation trials that the drug does have sufficient therapeutic benefits.
, however, the FDA rarely reverses drug approvals after confirming the failure of the trial.
, such as Roche Tecentriq, retained its bladder cancer adaptation approval after the failed IMVigor-211 trial.
, but in some cases, even if the FDA doesn't take any action, drugmakers may find it pointless to further promote failed drugs.
2019, Lilly Pharmaceuticals announced that Lartruvo, which treats late-stage soft tissue sarcoma, would be withdrawn from the market after a failed Phase 3 trial.
competitors, Mercadon Keytruda received accelerated approval for small cell lung cancer in June 2019 based on positive data from keyNOTE-158 and KEYNOTE-028 trials.
However, in January this year, the phase III clinical trial KEYNOTE-604 also suffered a setback, the results showed that Keytruda combined chemotherapy (etoposide plus platinum drugs) to treat a wide range of small cell lung cancer (ES-SCLC) can improve the patient's progression survival (PFS), but the total survival period (OS) did not achieve statistically improved.
, Roche Tecentriq, used in combination with chemotherapy, has also been approved for first-line treatment for small cell lung cancer, which reduces the risk of death by 30 percent.
AstraZeneta, was also approved in March last year, with combination therapies improving the risk of death by 27 per cent.
source: 1.Opdivo's in small cell lung cancer no more Bristol Myers pulls out after failure trial 2.Bristol-Myers Squibb Pulls Small Cell Lung Cancer For Opdivo