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trial failure

AbbVie terminates Phase 3 brain cancer study after Depatux-M shows no benefit

AbbVie has terminated a Phase 3 study of the efficacy of Depatux-M (depatuxizumab mafodotin) in the treatment of newly diagnosed glioblastoma (GBM) in patients whose tumours have epidermal growth factor receptor (EGFR) amplification, after it was identified in an interim analysis that the therapy presented no survival benefit to patients.

Boehringer's Pradaxa fails to meet Phase 3 endpoint in preventing recurrent stroke

Boehringer has announced that Pradaxa (dabigatran etexilate mesylate) has failed to meet its primary endpoint in its Phase 3 study, proving unable to show superiority over acetylsalicylic acid (ASA) in preventing recurrent stroke in patients with embolic stroke of undetermined source (ESUS).

The drug particularly failed to present a statistically significant difference in the risk of recurrent stroke. The manufacturer did, however, note that after one year of treatment, a trend emerged showing Pradaxa to improve this very metric over ASA.

BMS blockbuster Opdivo falls short at Phase 3 in MGMT-unmethylated glioblastoma multiforme

Bristol-Myers Squibb’s blockbuster immunotherapy Opdivo (nivolumab) has hit a hurdle, failing its primary endpoint in a Phase 3 trial investigating its efficacy in the treatment of newly diagnosed O6-methylguanine-DNA methyltransferase (MGMT)-unmethylated glioblastoma multiforme (GBM).

Data from the trial revealed that the drug, when used in combination with radiation, did not sufficiently improve overall survival (OS). However, Opdivo’s safety profile was found to be consistent with previous studies.

Allergy Therapeutics' adjuvanted birch allergoid drug shocks with Phase 3 failure

UK-based biotech firm Allergy Therapeutics has been left disappointed after it became evident that its adjuvanted birch allergoid product failed its primary endpoint in the treatment of birch-pollen induced seasonal allergic rhinitis.

Newly revealed Phase 3 data indicated that the drug “did not show a statistically significant difference between active and placebo arms”, with trial participants failing to achieve an adequate combined symptom medication score averaged over the peak birch pollen season.

Lilly's Lartruvo/chemo combo surprises with Phase 3 failure in soft tissue carcinoma

Eli Lilly has reluctantly pulled back the curtain on new Phase 3 data for its platelet-derived growth factor receptor alpha (PDGFR-α) blocking antibody Lartruvo (olaratumab), revealing that the therapy failed to present clinical benefit in the treatment of advanced or metastatic soft tissue sarcoma (STS) when used in combination with standard of care chemotherapy drug doxorubicin, compared to doxorubicin alone.

The ANNOUNCE study sought to determine the overall survival (OS) benefit of the combination – it’s primary endpoint.

Verona's shares drop 34% on Phase 2 failure of nebulised ensifentrine in COPD

Verona Pharma has seen its shares crater following the Phase 2 failure of its nebulised ensifentrine, known as RPL554, in combination with Boehringer’s Stiolto Respimat (tiotropium/olodaterol) in the treatment of chronic obstructive pulmonary disease (COPD).

Share value fell by as much as 34% when news broke that the therapy failed to meet statistical significance in its primary endpoint of improving lung function compared to placebo, as measured by peak forced expiratory volume in one second (FEV1).

Phase 3 failure of asthma therapy sends Vectura's ailing shares falling

Vectura has announced it is terminating development of its severe asthma therapy VR475, an inhaled formulation of the corticosteroid budesonide, after it failed in Phase 3 trials to demonstrate a significant impact on the condition.

Specifically, the therapy failed to show a reduction in the annualised rate of asthma exacerbations compared to placebo in severe asthma that is uncontrolled despite the use of high doses of inhaled steroids and a second controller medication. The drug was delivered via Vectura’s proprietary nebuliser.

Zynerba's cannabis-based transdermal patch fails at Phase 1, shares slide 21%

Image Credit: Michel Porro/Getty Images

As public focus on the issue of medicinal cannabis continues to grow, Zynerba Pharmaceuticals has announced that its transdermal tetrahydrocannabinol (THC) patch ZYN001 has failed in Phase 1 trials to achieve targeted levels of THC in the blood of patients.

Zynerba attempted to assess the efficacy of a range of dosages and wear times in 60 participants, who wore the patches for a duration of between 24 hours and two weeks, but the drug did not hit the target levels of 5ng/ml to 15ng/ml of THC. The news caused the company shares to plummet 21%.

Summit Pharma axes Duchenne drug after Phase 2 failures

Summit Therapeutics has revealed it is to terminate development of its Duchenne muscular dystrophy (DMD) drug ezutromid after it failed to achieve its primary or secondary endpoints in a Phase 2 trial after 48 weeks of treatment.

Keytruda combo fails at Phase 3 in metastatic melanoma

Shares in biopharma firm Incyte were sent reeling by as much as 20% when the company announced that the results of a Phase 3 study had revealed that its IDO1 inhibitor epacadostat, when applied in combination with MSD’s Keytruda (pembrolizumab), failed to meet its primary endpoint of improving progression-free survival (PFS) in patients with unresectable or metastatic melanoma compared to Keytruda alone.

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