Common Safety Follow-up Trial of Tecemotide (L-BLP25)

• Tecemotide (Biological), also known as L-BLP25: Subjects who received tecemotide (L-BLP25) for the treatment of non-small cell lung cancer (NSCLC) or multiple myeloma in a feeder trial will continue to be treated with tecemotide (L-BLP25) and have safety assessments performed until the discontinuation criteria in the respective feeder trial protocol are met.
• No intervention (Other): Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25), will only be observed for progressive disease (PD) (if applicable) and survival in 6-month intervals and will not be provided treatment with tecemotide (L-BLP25).

Primary outcomes

• Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death [Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years]: An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect, AEs leading to discontinuation and AEs leading to death.

Secondary outcomes

• Overall Survival (OS) [From randomization to death, assessed up to 3.6 years]: Overall survival time was defined as the time from randomization to death. Subjects without events were censored at the last date they were known to be alive.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Signed written informed consent.
* Registration and treatment in a clinical trial with tecemotide (L-BLP25) under sponsorship of Merck KGaA/EMD Serono/Merck Serono Japan (feeder trial). \[Note, subjects who have been allocated to treatments not containing tecemotide (L BLP25) in the feeder trial are eligible for this trial and will be followed-up for progressive disease (PD) (if applicable) and survival.\]
* End of Treatment procedures have been performed in the feeder trial.
* Other protocol defined inclusion criteria could apply

Exclusion Criteria

* Pregnancy and lactation period; women of childbearing potential, unless using effective contraception as determined by the Investigator. Subjects whom the Investigator considers may be at risk of pregnancy will have a pregnancy test performed per institutional standard
* Known hypersensitivity to any of the trial treatment ingredients (if applicable)
* Legal incapacity or limited legal capacity
* Any other reason that, in the opinion of the Investigator, precludes the subject from participating in the trial
* Other protocol defined exclusion criteria could apply

Participant flow

Outcome results

• Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death (Primary), Number, Subjects: Non-small Cell Lung Cancer (NSCLC) 12; Multiple Myeloma 7
• Overall Survival (OS) (Secondary)

Adverse events

Time frame: Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)

Serious adverse events by term

Other adverse events by term

68 more terms not shown.

Limitations and caveats: The study was terminated prematurely as the sponsor decided to discontinue program with Tecemotide in non-small cell lung cancer (NSCLC).

• Medical Responsible, Study director, Merck KGaA, Darmstadt, Germany