News briefing: Otsuka’s $886M cancer drug is now a 3-time loser in PhIII; Keytruda approved for classical Hodgkin lymphoma
Two years after Otsuka unveiled a flop in their first Phase III trial of guadecitabine as a frontline treatment, they’re back with 2 more pivotal setbacks. But researchers are leaving the door ajar for more studies ahead.
The company’s California subsidiary Astex, acquired for $886 million back in 2013, says that ASTRAL-2 and ASTRAL-3 — which recruited patients who had been previously treated for AML and MDS/CMML — couldn’t beat the mark for statistical significance.
Astex president and CMO Mohammad Azab noted:
The ASTRAL studies generated for the medical community one of the largest bodies of clinical and genetic data from prospective randomized studies using hypomethylating agent treatment. Guadecitabine was associated with improved outcomes in certain subgroups, but that needs to be validated by additional studies.
The actual data will be presented at a scientific conference to be selected later.
Otsuka was pulled in by promising mid-stage data on the drug, confident that it had the kind of proof-of-concept data in humans that justified an ambitious Phase III program. The drug is billed as a next-generation DNA hypomethylating agent, but it initially failed against a group of patients who received one of several alternative therapies: azacitidine, decitabine, or low dose cytarabine. — John Carroll
Keytruda gets another approval, this time in classical Hodgkin lymphoma
The FDA has approved an expanded indication for Merck’s best-seller Keytruda drug.
Adults with relapsed or refractory classical Hodgkin lymphoma are now able to be treated with Keytruda as a monotherapy, Merck said Thursday. The approval is based on the results from a Phase III study that showed Keytruda reduced the risk of disease progression or death by 35% compared to Takeda’s Adcetris.
Additionally, Keytruda received an updated pediatric indication for the treatment refractory cHL, or cHL that has relapsed after two or more lines of therapy.
Merck’s Phase III study was a randomized, open-label, active-controlled trial conducted in 304 patients, who received either Keytruda or Adcetris through an IV once every three weeks. Treatment was continued until unacceptable toxicity, disease progression or until patients reached 35 dosing cycles after about two years.
Keytruda is already approved to treat a variety of cancers, including melanoma, non-small cell lung cancer, small cell lung cancer, and head and neck squamous cell cancer, among others. The drug netted Merck more than $6.6 billion in sales through the first half of 2020, and peak annual sales could hit $24.3 billion by 2026, according to EvaluatePharma. — Max Gelman
Peter Thiel-backed skin microbiome biotech nets $17 million Series B
Azitra, a biotech once funded by billionaire Peter Thiel, has pulled in another $17 million, including $8 million from its partners at Leaps by Bayer.
The companies partnered up earlier this year to develop Azitra’s skin microbiome products, mainly the biotech’s proprietary panel of Staphylococcus epidermidis strains to identify potential treatments for skin conditions and diseases. Thursday’s cash will build on that collaboration deal, which brings Azitra’s total money raised to $34 million when including the rest of the round after an extended Series A closed in late 2019.
Azitra is focusing its research in three specific areas: consumer skincare products, bio-engineered skin disease treatments and advanced microbiome products for military and public health applications. Its lead candidate is a cream for cancer patients who develop rashes while taking EGFR therapy, currently in Phase I trials. — Max Gelman